Covid 19 Research using Clinical Trials (Home Page)
Report for D001168: Arthritis NIH
(Synonyms: Arthri, Arthrit, Arthriti, Arthritis)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (24)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug497 | CT-Scan Wiki | 0.41 |
| drug1981 | Questionnaire by phone call Wiki | 0.29 |
| drug474 | COVID-19 e-package: Psychological wellbeing for healthcare workers Wiki | 0.29 |
| drug1857 | Placebo to match filgotinib Wiki | 0.29 |
| drug473 | COVID-19 diagnostic test Wiki | 0.29 |
| drug484 | COVID-19 test, polymerase chain reaction for SARS-CoV-2 Wiki | 0.29 |
| drug494 | CPI-006 Wiki | 0.29 |
| drug940 | Filgotinib Wiki | 0.29 |
| drug487 | COVID-surgRES questionaire Wiki | 0.29 |
| drug479 | COVID-19 patients Wiki | 0.29 |
| drug495 | CRI management Wiki | 0.29 |
| drug2545 | Traditional antirheumatic drugs Wiki | 0.29 |
| drug1856 | Placebo to match adalimumab Wiki | 0.29 |
| drug43 | 40ml blood sample Wiki | 0.29 |
| drug477 | COVID-19 infection Wiki | 0.29 |
| drug470 | COVID-19 barrier box Wiki | 0.29 |
| drug2233 | Serological analyses to be lead on a pre-existing biobank Wiki | 0.29 |
| drug471 | COVID-19 convalescent hyperimmune plasma Wiki | 0.29 |
| drug123 | Adalimumab Wiki | 0.29 |
| drug1133 | Hydroxychloroquine/Chloroquine Wiki | 0.29 |
| drug1634 | Non-convalescent fresh frozen plasma (Standard plasma) Wiki | 0.29 |
| drug472 | COVID-19 convalescent plasma Wiki | 0.14 |
| drug2977 | questionnaire assesment Wiki | 0.13 |
| drug1086 | Hydroxychloroquine Wiki | 0.03 |
Correlated MeSH Terms (15)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001172 | Arthritis, Rheumatoid NIH | 0.76 |
| D015535 | Arthritis, Psoriatic NIH | 0.58 |
| D001167 | Arteritis NIH | 0.41 |
| D012859 | Sjogren's Syndrome NIH | 0.41 |
| D008180 | Lupus Erythematosus, Systemic NIH | 0.35 |
| D001327 | Autoimmune Diseases NIH | 0.33 |
| D011111 | Polymyalgia Rheumatica NIH | 0.33 |
| D013700 | Giant Cell Arteritis NIH | 0.33 |
| D001171 | Arthritis, Juvenile NIH | 0.29 |
| D003095 | Collagen Diseases NIH | 0.29 |
| D025241 | Spondylarthritis NIH | 0.29 |
| D012216 | Rheumatic Diseases NIH | 0.26 |
| D059350 | Chronic Pain NIH | 0.12 |
| D003141 | Communicable Diseases NIH | 0.02 |
| D007239 | Infection NIH | 0.02 |
Correlated HPO Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001369 | Arthritis HPO | 1.00 |
| HP:0001370 | Rheumatoid arthritis HPO | 0.76 |
| HP:0012089 | Arteritis HPO | 0.41 |
| HP:0002725 | Systemic lupus erythematosus HPO | 0.35 |
| HP:0002960 | Autoimmunity HPO | 0.33 |
| HP:0012532 | Chronic pain HPO | 0.12 |
There are 12 clinical trials
Clinical Trials
1 A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE).
NCT04115748 Psoriatic Arthritis Drug: Filgotinib Drug: Adalimumab Drug: Placebo to match filgotinib Drug: Placebo to match adalimumab MeSH:Arthritis Arthritis, Psoriatic
HPO:Arthritis Polyarticular arthritis
Primary Outcomes
Description: ACR20 is calculated as an at least 20% improvement from baseline in both tender and swollen joint counts and an at least 20% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire - disability index (HAQ-DI) and an acute-phase reactant high sensitivity C-reactive protein (hsCRP).
Measure: Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 Time: Week 12
Secondary Outcomes
Description: PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS covers the physician's global assessment of disease activity and participant's global assessment of disease activity, the Short-Form Health Survey (SF-36) Physical Component Score (PCS), swollen and tender joint counts, enthesitis and dactylitis, as well as hsCRP. A lower score indicates better function.
Measure: Change from Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Time: Baseline; Weeks 4, 16
Description: Minimal disease activity will be determined by tender and swollen joint counts, PASI or body surface area (BSA), participant's assessment of pain, participant's global assessment of disease activity, HAQ-DI, and SPARCC Enthesitis Index.
Measure: Percentage of Participants who Achieved Minimal Disease Activity (MDA) Response Time: Weeks 4, 8, 12, 16
Description: VLDA will be determined by tender and swollen joint counts, PASI or BSA, participant's assessment of pain, participant's global assessment of disease activity, HAQ-DI, and SPARCC Enthesitis Index.
Measure: Percentage of Participants who Achieved Very Low Disease Activity (VLDA) Response Time: Weeks 4, 8, 12, 16
Description: DAPSA is a psoriatic arthritis disease activity measure, calculated by summing swollen and tender joint counts, participant's assessment of pain, participant's global assessment of disease activity, and hsCRP.
Measure: Change from Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: The physician's global assessment of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician, using a 6-point scale, which ranges from 0 (cleared) to 5 (severe).
Measure: Change from Baseline in Physician's Global Assessment of Psoriasis (PhGAP) in Participants with Psoriasis Covering ≥ 3% of the BSA at Baseline Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Measure: Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) in Participants with Psoriatic Nail Involvement at Baseline Time: Baseline; Weeks 4, 8, 12, 16
Description: Enthesitis will be assessed using LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Measure: Change from Baseline in Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16
Description: The PsAID questionnaire assesses the impact of PsA on people's lives. It is a 12-item questionnaire, where each item will be scored between 0 and 10. All items are prioritized according to importance of the health domain it represents. A higher score on the PsAID indicates more impact of the disease.
Measure: Change from Baseline in 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) Time: Baseline; Weeks 4, 16
Description: PASDAS LDA is defined as PASDAS ≤ 3.2.
Measure: Percentage of Participants with Psoriatic Arthritis Disease Activity Score (PASDAS) Low Disease Activity (LDA) Time: Baseline; Weeks 4, 16
Description: PASDAS remission is defined as PASDAS ≤ 1.9.
Measure: Percentage of Participants who Achieve PASDAS Remission Time: Baseline; Weeks 4, 16
Description: ACR20 is calculated as an at least 20% improvement from baseline in both tender and swollen joint counts and an at least 20% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI and an acute-phase reactant hsCRP.
Measure: Percentage of Participants who Achieve an American College of Rheumatology 20% Improvement Response Time: Baseline; Weeks 2, 4, 8, 16
Description: ACR50 is calculated as an at least 50% improvement from baseline in both tender and swollen joint counts and an at least 50% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI, and an acute-phase reactant hsCRP.
Measure: Percentage of Participants who Achieve an American College of Rheumatology 50% Improvement Response Time: Weeks 2, 4, 8, 12, 16
Description: ACR70 is calculated as an at least 70% improvement from baseline in both tender and swollen joint counts and an at least 70% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant'ss assessment of pain, HAQ-DI and an acute-phase reactant (high sensitivity C-reactive protein [hsCRP]).
Measure: Percentage of Participants who Achieve an American College of Rheumatology 70% Improvement Response Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: Components of ACR include tender and swollen joint counts, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI and hsCRP.
Measure: Change from Baseline in Individual Components of the American College of Rheumatology Response Criteria Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity and hsCRP. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Measure: Change from Baseline in Participants who Achieve Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: DAS28(CRP) LDA is defined as DAS28(CRP) ≤ 3.2.
Measure: Percentage of Participants who Achieve DAS28(CRP) LDA Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: DAS28(CRP) remission is defined as DAS28(CRP) < 2.6.
Measure: Percentage of Participants who Achieve DAS28(CRP) Remission Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: Time to achieve DAS28(CRP) LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAS28(CRP) LDA, or censored if a participant does not achieve DAS28(CRP) LDA or missing.
Measure: Time to Achieve DAS28(CRP) LDA Time: First dose date up to 16 weeks
Description: DAPSA LDA is defined as DAPSA ≤ 14.
Measure: Percentage of Participants who Achieve DAPSA LDA Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: DAPSA remission is defined as DAPSA ≤ 4.
Measure: Percentage of Participants who Achieve DAPSA Remission Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: Time to achieve DAPSA LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAPSA LDA, or censored if a participant does not achieve DAPSA LDA or missing.
Measure: Time to Achieve DAPSA LDA Time: First dose date up to 16 weeks
Description: PsARC consists of four components: assessment of joint tenderness and swelling utilizing 68/66 joint counts respectively, participant's global assessment of disease activity, and physician's global assessment of disease activity.
Measure: Percentage of Participants who Achieve Psoriatic Arthritis Response Criteria (PsARC) Response Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: PASI will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Measure: Change from Baseline in Psoriasis Area and Severity Index (PASI) in Participants with Psoriasis Covering ≥ 3% of the BSA at Baseline Time: Baseline; Weeks 4, 8, 12, 16
Description: The PASI50 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI50 response represents at least a 50% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 50% Improvement (PASI50) Response Time: Weeks 4, 8, 12, 16
Description: The PASI75 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI75 response represents at least a 75% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 75% Improvement (PASI75) Response with Psoriasis Covering ≥ 3% of the Body Surface Area Time: Weeks 4, 8, 12, 16
Description: The PASI90 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI90 response represents at least a 90% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 90% Improvement (PASI90) Response Time: Weeks 4, 8, 12, 16
Description: The PASI100 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI100 response represents a 100% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 100% Improvement (PASI100) Response Time: Weeks 4, 8, 12, 16
Description: The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. Tenderness is quantified as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.
Measure: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16
Description: LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [no tenderness] to 3 [tender and withdrawn]. A higher LDI indicates worse dactylitis.
Measure: Change from Baseline in Leeds Dactylitis Index (LDI) in Participants with Dactylitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16
Description: TDC will be assessed in participants with dactylitis at Baseline. TDC is a simple count based on the presence or absence of tender joints.
Measure: Change from Baseline in Tender Dactylitis Count (TDC) Time: Baseline; Weeks 4, 8, 12, 16
Description: HAQ-DI is used to monitor the participant's self-assessed physical function or disability. This 20 -question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 function areas (getting dressed, arising, eating, walking, hygiene, reaching, gripping, and activities). HAQ-DI total score ranges from 0 to 3, with higher scores indicating greater dysfunction.
Measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: FACIT-Fatigue is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). FACIT-Fatigue total score ranges 0 to 52. Higher scores represent better fatigue status.
Measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Time: Baseline; Weeks 4, 16
Description: Composite endpoint of change from baseline in MCS and PCS scores in SF-36 Version 2. The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain will be scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Measure: Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes SF-36 Version 2 Time: Baseline; Weeks 4, 16
2 COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
Primary Outcomes
Description: ACR20 is calculated as an at least 20% improvement from baseline in both tender and swollen joint counts and an at least 20% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire - disability index (HAQ-DI) and an acute-phase reactant high sensitivity C-reactive protein (hsCRP).
Measure: Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 Time: Week 12Secondary Outcomes
Description: PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS covers the physician's global assessment of disease activity and participant's global assessment of disease activity, the Short-Form Health Survey (SF-36) Physical Component Score (PCS), swollen and tender joint counts, enthesitis and dactylitis, as well as hsCRP. A lower score indicates better function.
Measure: Change from Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Time: Baseline; Weeks 4, 16Description: Minimal disease activity will be determined by tender and swollen joint counts, PASI or body surface area (BSA), participant's assessment of pain, participant's global assessment of disease activity, HAQ-DI, and SPARCC Enthesitis Index.
Measure: Percentage of Participants who Achieved Minimal Disease Activity (MDA) Response Time: Weeks 4, 8, 12, 16Description: VLDA will be determined by tender and swollen joint counts, PASI or BSA, participant's assessment of pain, participant's global assessment of disease activity, HAQ-DI, and SPARCC Enthesitis Index.
Measure: Percentage of Participants who Achieved Very Low Disease Activity (VLDA) Response Time: Weeks 4, 8, 12, 16Description: DAPSA is a psoriatic arthritis disease activity measure, calculated by summing swollen and tender joint counts, participant's assessment of pain, participant's global assessment of disease activity, and hsCRP.
Measure: Change from Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Time: Baseline; Weeks 2, 4, 8, 12, 16Description: The physician's global assessment of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician, using a 6-point scale, which ranges from 0 (cleared) to 5 (severe).
Measure: Change from Baseline in Physician's Global Assessment of Psoriasis (PhGAP) in Participants with Psoriasis Covering ≥ 3% of the BSA at Baseline Time: Baseline; Weeks 2, 4, 8, 12, 16Description: Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Measure: Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) in Participants with Psoriatic Nail Involvement at Baseline Time: Baseline; Weeks 4, 8, 12, 16Description: Enthesitis will be assessed using LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Measure: Change from Baseline in Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16Description: The PsAID questionnaire assesses the impact of PsA on people's lives. It is a 12-item questionnaire, where each item will be scored between 0 and 10. All items are prioritized according to importance of the health domain it represents. A higher score on the PsAID indicates more impact of the disease.
Measure: Change from Baseline in 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) Time: Baseline; Weeks 4, 16Description: PASDAS LDA is defined as PASDAS ≤ 3.2.
Measure: Percentage of Participants with Psoriatic Arthritis Disease Activity Score (PASDAS) Low Disease Activity (LDA) Time: Baseline; Weeks 4, 16Description: PASDAS remission is defined as PASDAS ≤ 1.9.
Measure: Percentage of Participants who Achieve PASDAS Remission Time: Baseline; Weeks 4, 16Description: ACR20 is calculated as an at least 20% improvement from baseline in both tender and swollen joint counts and an at least 20% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI and an acute-phase reactant hsCRP.
Measure: Percentage of Participants who Achieve an American College of Rheumatology 20% Improvement Response Time: Baseline; Weeks 2, 4, 8, 16Description: ACR50 is calculated as an at least 50% improvement from baseline in both tender and swollen joint counts and an at least 50% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI, and an acute-phase reactant hsCRP.
Measure: Percentage of Participants who Achieve an American College of Rheumatology 50% Improvement Response Time: Weeks 2, 4, 8, 12, 16Description: ACR70 is calculated as an at least 70% improvement from baseline in both tender and swollen joint counts and an at least 70% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant'ss assessment of pain, HAQ-DI and an acute-phase reactant (high sensitivity C-reactive protein [hsCRP]).
Measure: Percentage of Participants who Achieve an American College of Rheumatology 70% Improvement Response Time: Baseline; Weeks 2, 4, 8, 12, 16Description: Components of ACR include tender and swollen joint counts, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI and hsCRP.
Measure: Change from Baseline in Individual Components of the American College of Rheumatology Response Criteria Time: Baseline; Weeks 2, 4, 8, 12, 16Description: DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity and hsCRP. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Measure: Change from Baseline in Participants who Achieve Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) Time: Baseline; Weeks 2, 4, 8, 12, 16Description: DAS28(CRP) LDA is defined as DAS28(CRP) ≤ 3.2.
Measure: Percentage of Participants who Achieve DAS28(CRP) LDA Time: Baseline; Weeks 2, 4, 8, 12, 16Description: DAS28(CRP) remission is defined as DAS28(CRP) < 2.6.
Measure: Percentage of Participants who Achieve DAS28(CRP) Remission Time: Baseline; Weeks 2, 4, 8, 12, 16Description: Time to achieve DAS28(CRP) LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAS28(CRP) LDA, or censored if a participant does not achieve DAS28(CRP) LDA or missing.
Measure: Time to Achieve DAS28(CRP) LDA Time: First dose date up to 16 weeksDescription: DAPSA LDA is defined as DAPSA ≤ 14.
Measure: Percentage of Participants who Achieve DAPSA LDA Time: Baseline; Weeks 2, 4, 8, 12, 16Description: DAPSA remission is defined as DAPSA ≤ 4.
Measure: Percentage of Participants who Achieve DAPSA Remission Time: Baseline; Weeks 2, 4, 8, 12, 16Description: Time to achieve DAPSA LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAPSA LDA, or censored if a participant does not achieve DAPSA LDA or missing.
Measure: Time to Achieve DAPSA LDA Time: First dose date up to 16 weeksDescription: PsARC consists of four components: assessment of joint tenderness and swelling utilizing 68/66 joint counts respectively, participant's global assessment of disease activity, and physician's global assessment of disease activity.
Measure: Percentage of Participants who Achieve Psoriatic Arthritis Response Criteria (PsARC) Response Time: Baseline; Weeks 2, 4, 8, 12, 16Description: PASI will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Measure: Change from Baseline in Psoriasis Area and Severity Index (PASI) in Participants with Psoriasis Covering ≥ 3% of the BSA at Baseline Time: Baseline; Weeks 4, 8, 12, 16Description: The PASI50 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI50 response represents at least a 50% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 50% Improvement (PASI50) Response Time: Weeks 4, 8, 12, 16Description: The PASI75 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI75 response represents at least a 75% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 75% Improvement (PASI75) Response with Psoriasis Covering ≥ 3% of the Body Surface Area Time: Weeks 4, 8, 12, 16Description: The PASI90 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI90 response represents at least a 90% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 90% Improvement (PASI90) Response Time: Weeks 4, 8, 12, 16Description: The PASI100 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI100 response represents a 100% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 100% Improvement (PASI100) Response Time: Weeks 4, 8, 12, 16Description: The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. Tenderness is quantified as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.
Measure: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16Description: LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [no tenderness] to 3 [tender and withdrawn]. A higher LDI indicates worse dactylitis.
Measure: Change from Baseline in Leeds Dactylitis Index (LDI) in Participants with Dactylitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16Description: TDC will be assessed in participants with dactylitis at Baseline. TDC is a simple count based on the presence or absence of tender joints.
Measure: Change from Baseline in Tender Dactylitis Count (TDC) Time: Baseline; Weeks 4, 8, 12, 16Description: HAQ-DI is used to monitor the participant's self-assessed physical function or disability. This 20 -question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 function areas (getting dressed, arising, eating, walking, hygiene, reaching, gripping, and activities). HAQ-DI total score ranges from 0 to 3, with higher scores indicating greater dysfunction.
Measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Time: Baseline; Weeks 2, 4, 8, 12, 16Description: FACIT-Fatigue is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). FACIT-Fatigue total score ranges 0 to 52. Higher scores represent better fatigue status.
Measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Time: Baseline; Weeks 4, 16Description: Composite endpoint of change from baseline in MCS and PCS scores in SF-36 Version 2. The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain will be scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Measure: Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes SF-36 Version 2 Time: Baseline; Weeks 4, 16The trial is a prospective, observational study aiming to identify risk factors for serious COVID-19 infection by evaluating clinical measures and biomarkers of inflammation in patients with inflammatory rheumatic disease hospitalized with COVID-19 compared with control groups.
NCT04335747 Rheumatoid Arthritis Psoriatic Arthritis Axial Spondyloarthritis Systemic Lupus Erythematosus Giant Cell Arteritis Other: COVID-19 infection MeSH:Arthritis Arthritis, Psoriatic Rheumatic Diseases Polymyalgia Rheumatica Giant Cell Arteritis Arteritis Lupus Erythematosus, Systemic Collagen Diseases
HPO:Arteritis Arthritis Polyarticular arthritis Systemic lupus erythematosus
Primary Outcomes
Description: The objective is to examine whether increased disease activity leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease
Measure: Disease activity Time: Last registration of disease activity in the medical journal before admission/inclusion
Secondary Outcomes
Description: Examine whether immune modulating treatments protect or leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease.
Measure: Immune modulating treatments Time: Current immune modulating treatments at admission/inclusion
Description: Identify prognostic biomarkers by comparing serology of patients with inflammatory rheumatic disease hospitalized with COVID-19 and comparing them with the two control groups
Measure: Biomarkers Time: Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1
3 Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease
Primary Outcomes
Description: The objective is to examine whether increased disease activity leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease
Measure: Disease activity Time: Last registration of disease activity in the medical journal before admission/inclusionSecondary Outcomes
Description: Examine whether immune modulating treatments protect or leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease.
Measure: Immune modulating treatments Time: Current immune modulating treatments at admission/inclusionDescription: Identify prognostic biomarkers by comparing serology of patients with inflammatory rheumatic disease hospitalized with COVID-19 and comparing them with the two control groups
Measure: Biomarkers Time: Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1This epidemiological, transversal, cohort study aims to determine the potential influence of an active long-term hydroxychloroquine intake over the prevalence of a history of symptoms evocative of a COVID-19 infection in patients with a history of systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome or psoriatic arthritis, during the epidemic period in France. The information is gathered using a standardized questionnaire, by phone call.
NCT04345159 SARS-CoV-2 Systemic Lupus Erythematosus Rheumatoid Arthritis Sjogren's Syndrome Psoriatic Arthritis Other: Questionnaire by phone call MeSH:Arthritis Arthritis, Psoriatic Sjogren's Syndrome Lupus Erythematosus, Systemic Autoimmune Diseases
HPO:Arthritis Autoimmunity Polyarticular arthritis Systemic lupus erythematosus
Primary Outcomes
Description: Adjusted Odds Ratio measuring the association between an exposure to long-term hydroxychloroquine intake and a history of symptoms compatible with a COVID-19 infection.
Measure: Adjusted Odds Ratio Time: 4 months after inclusion
4 IMPACT RAPPORT: IMPact of Antimalarials on Covid Infections: a Case Control sTudy of RAPPORT
Primary Outcomes
Description: Adjusted Odds Ratio measuring the association between an exposure to long-term hydroxychloroquine intake and a history of symptoms compatible with a COVID-19 infection.
Measure: Adjusted Odds Ratio Time: 4 months after inclusionThis study aims to evaluate the experience of Alberta patients with inflammatory arthritis who participate in the the RAPPORT-ONTRAAC registry during the COVID-19 pandemic, specifically comparing the experience of those taking anti-malarial medications compared to those who do not. This registry includes approximately 2500 northern Alberta patients with inflammatory arthritis who receive highly complex therapies which may be associated with side effects. This program of data collection and research has been evaluating the effectiveness and safety as well as associated health care costs of rheumatoid and psoriatic arthritis patients since 2004. The principle investigators are based at the University of Alberta while the co-investigators are academic rheumatologists at the University of Alberta. The registry has approximately 900 patients taking anti-malarials combined with their complex therapies and ~ 1500 not on anti-malarials in combination with their complex therapies. We aim to perform a case control study evaluating the impact of anti-malarial drugs (eg. hydroxychloroquine and chloroquine) on the development of COVID-19 compared to those patients who are not on anti-malarial drugs over the next 6-12 months. In addition to frequent e-mail surveys screening for the clinical symptoms of COVID-19 and understanding their concomitant arthritis medication use, we will compare the healthcare outcomes of both groups of arthritis patients with and without COVID-19 for the duration of the pandemic. This information will provide critical information beyond an anecdotal level on whether or not anti-malarials truly provide a protective benefit against COVID-19 or reduce the severity of infection. A blood sample from all participants (Covid-19 positive and negative) will be drawn approximately six months into the study for measurement of antibodies to Covid-19 and possible blood types and HLA alleles. Additionally, this study will be linked to another study "Persistence of SARS-Cov2 in immunocompromised patients" which will specifically evaluate COVID-19 serology and nasopharyngeal swab findings in the subset of patients who develop COVID-19.
NCT04347798 Covid-19 Infection Rheumatoid Arthritis Psoriatic Arthritis Hydroxychloroquine Other: Hydroxychloroquine/Chloroquine MeSH:Infection Communicable Diseases Arthritis Arthritis, Rheumatoid Arthritis, Psoriatic
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis
Primary Outcomes
Description: Number of patients developing signs and symptoms of Covid-19 or other infections
Measure: Impact of anti-malarials on the development and severity of Covid-19 in the anti-malarial group compared to the non-anti-malarial group Time: 12 months
Secondary Outcomes
Description: Number of patients developing Covid-19 infection
Measure: Incidence of Covid-19 infection in the anti-malarial group compared to the non-anti-malarial group Time: 12 months
Description: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action
Measure: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action Time: 12 months
Other Outcomes
Description: Quantitative measurement of Covid-19 serology to understand possible differences in degree of immune response adjusted for anti-malarial and/or biologic exposure
Measure: Quantification of Covid-19 antibodies in anti-malarial vs non-anti-malarial groups of inflammatory arthritis patients Time: 6 months
5 Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak
Primary Outcomes
Description: Number of patients developing signs and symptoms of Covid-19 or other infections
Measure: Impact of anti-malarials on the development and severity of Covid-19 in the anti-malarial group compared to the non-anti-malarial group Time: 12 monthsSecondary Outcomes
Description: Number of patients developing Covid-19 infection
Measure: Incidence of Covid-19 infection in the anti-malarial group compared to the non-anti-malarial group Time: 12 monthsDescription: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action
Measure: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action Time: 12 monthsOther Outcomes
Description: Quantitative measurement of Covid-19 serology to understand possible differences in degree of immune response adjusted for anti-malarial and/or biologic exposure
Measure: Quantification of Covid-19 antibodies in anti-malarial vs non-anti-malarial groups of inflammatory arthritis patients Time: 6 monthsClinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration. In recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first SARS epidemy. Even after the end of quarantine several patients were still with symptom of avoiding mainly agoraphobia, frequent hand washing and a carefull return to normal life COVID-19 infection is already associated with psychological symptom like anxiety, depression, sleep disorders and symptoms of acute stress However psychological impact of quarantine is on none in chronic painful inflammatory rheumatism in France. The prevalence of rheumatoid arthritis is 0.5% of the population with frequent comorbidity such as anxiety and depression. During the quarantine secondary to COVID-19 pandemic it's possible to evaluated the psychological impact of adult RA patients. The present study is an "emergency" being realize before the end of the quarantine.
NCT04351399 Sars-CoV2 Rheumatic Diseases Rheumatoid Arthritis Chronic Pain Other: questionnaire assesment MeSH:Arthritis Arthritis, Rheumatoid Rheumatic Diseases Collagen Diseases Chronic Pain
HPO:Arthritis Chronic pain Polyarticular arthritis Rheumatoid arthritis
Primary Outcomes
Measure: Frequency of RA patients with emotional impact (feeling of isolation) Time: maximum 1 week from baseline on
Secondary Outcomes
Description: Self reported questionnaire with questions to assess the characteristic,intensity of pain on quality of life, and consumption of analgesic.
Measure: self-reported questionnaire for painful Time: maximum 1 week from baseline on
6 Immune Cells and the Coronavirus for Inflammatory Arthritis
Primary Outcomes
Measure: Frequency of RA patients with emotional impact (feeling of isolation) Time: maximum 1 week from baseline onSecondary Outcomes
Description: Self reported questionnaire with questions to assess the characteristic,intensity of pain on quality of life, and consumption of analgesic.
Measure: self-reported questionnaire for painful Time: maximum 1 week from baseline onA team at the University of Manchester are developing a test that tcould be helpful in detecting immunity to the Coronavirus (which causes the COVID-19 disease) in participants with inflammatory arthritis. It is based on a flu assay has already developed; the team will replace the flu antigen with a Coronavirus antigen to see if it is effective. This project aims to develop a test to see if people who have had the virus have developed immunity to it. This could help to predict who might or might not get the disease a second time, who should stay at home to be protected from potential infection or who will not develop any symptoms, even if exposed to the virus. When vaccination trials against the Coronavirus will be launched, this test could also help to see if the vaccine is effective.
NCT04363047 SARS Virus Other: 40ml blood sample MeSH:Arthritis
HPO:Arthritis Polyarticular arthritis
Primary Outcomes
Description: the prevalence and abundance of CD4+ T lymphocytes specifically recognizing SARS-CoV-2 in COVID-19 patients with inflammatory arthritis, in pre- and post-infection samples; in patients without COVID-19 and in healthy volunteers with or without COVID-19. Correlation of these cells with COVID-19 severity.
Measure: Prevalence and abundance of CD4+ T lymphocytes Time: 2 years
7 Antimalarial and Covid 19 in Rheumatoid Arthritis
Primary Outcomes
Description: the prevalence and abundance of CD4+ T lymphocytes specifically recognizing SARS-CoV-2 in COVID-19 patients with inflammatory arthritis, in pre- and post-infection samples; in patients without COVID-19 and in healthy volunteers with or without COVID-19. Correlation of these cells with COVID-19 severity.
Measure: Prevalence and abundance of CD4+ T lymphocytes Time: 2 yearsThe antimalarial agent hydroxychloroquine(HCQ) have been used widely used for the treatment of rheumatoid arthritis and systemic lupus erythematosus. These compounds lead to improvement of clinical and laboratory parameters, but their slow onset of action differ them from glucocorticoids and nonsteroidal antiinflammatory agents. Among rheumatic diseases, the primary role of HCQ is in the management of articular and skin manifestations of systemic lupus erythematosus (SLE) and the treatment of mild to moderately active rheumatoid arthritis (RA).
NCT04389320 Rheumatoid Arthritis Drug: Hydroxychloroquine MeSH:Arthritis Arthritis, Rheumatoid
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis
Primary Outcomes
Description: serum level
Measure: immunoglobulin mesurement Time: 1 month
8 Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation
Primary Outcomes
Description: serum level
Measure: immunoglobulin mesurement Time: 1 monthThe current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Most patients with Juvenile Rheumatoid Arthritis benefit from long-term immunmodulatory therapy (DMARD - disease modifying anti-rheumatic drug), more or less combined with regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.The present study will characterize this issue by defining the proportion of patients whose usual treatment of Rheumatoid Arthritis has been modified in relation to the actual sanitary crisis.
NCT04393233 Rheumatoid Arthritis COVID MeSH:Arthritis Arthritis, Rheumatoid
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis
Primary Outcomes
Description: Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD
Measure: Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis Time: 1 Day
9 Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe
Primary Outcomes
Description: Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD
Measure: Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis Time: 1 DayThe coronavirus disease 2019 (COVID-19) pandemic is a potentially fatal disease that represents a great global public health concern. In European countries such as Spain, Italy, Germany, Portugal, England and France, the pandemic has been of utmost importance. To date, no treatment has been robustly validated, and two theoretically opposite therapeutic strategies are proposed, based either on antiretroviral therapy or on immunomodulating agents. In this complex context, people living with immune-mediated inflammatory diseases (IMID) raise specific concerns due to their potentially increased risk of infections or of severe infections. Among IMID, Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis are some key diseases. In this cross-sectional, observational, multi-centric study, the investigators aim to assess both clinical and serological prevalence of COVID-19 among samples of IMID patients in Europe. In parallel, the investigators aim to compare the prevalence of COVID-19 seroconversion across these five IMIDs, their penetration across different 6 European countries (France, Italy, Spain, Germany, United Kingdom and Portugal), and to assess the severity of COVID-19 in these patients. Moreover, changes in treatment will be assessed, including immunomodulatory tapering or discontinuation, its causes over the outbreak period, as well as the incidence of IMID flares and their severity over this same period. Finally, patient's perceptions towards the pandemic will be evaluated and compared to medication beliefs. Data will be collected through questionnaires during medical visit or phone consultation and serological tests will be performed within routine blood collection. As so, all study procedures are comprised within usual care. Through this study the investigators expect to have a better knowledge of the clinical and serological prevalence of COVID-19 in IMID across Europe, along with the psychological, clinical, and therapeutic impact of COVID-19 in this particular patient population.
NCT04397237 COVID-19 Systemic Lupus Erythematosus Sjogren's Syndrome Axial Spondyloarthritis Rheumatoid Arthritis Giant Cell Arteritis MeSH:Arthritis Arthritis, Rheumatoid Sjogren's Syndrome Spondylarthritis Polymyalgia Rheumatica Giant Cell Arteritis Arteritis Lupus Erythematosus, Systemic Autoimmune Diseases
HPO:Arteritis Arthritis Autoimmunity Polyarticular arthritis Rheumatoid arthritis Systemic lupus erythematosus
Primary Outcomes
Description: ELISA tests for COVID-19 antibodies
Measure: COVID-19 seroconversion Time: 1 day, during routine blood collection
Description: Case report form filled by the health professional
Measure: COVID-19 infection Time: During medical visit or phone consultation, up to 2 hours
Secondary Outcomes
Description: Descriptive analysis for each disease's rate
Measure: Seroconversion rate by disease Time: 1 day, during routine blood collection
Description: Descriptive analysis for each country's rate
Measure: Penetration across Europe Time: 1 day, during routine blood collection
Description: World Health Organization ordinal scale for clinical improvement at any given point of the infection, going from 0 to 8, where higher scores means worse outcome.
Measure: COVID-19 severity Time: During medical visit, up to 1 hour
Description: Descriptive analysis for overall and COVID-19-linked mortality rates
Measure: COVID-19 mortality rate Time: During contact with family members, up to 1 hour
Description: Case report form filled by the health professional
Measure: COVID-19 impact on immunomodulatory treatment Time: During medical visit, up to 1 hour
Description: Case report form filled by the patient
Measure: Patient-reported flares Time: During medical visit, up to 1 hour
Description: Fear of COVID-19 scale, going from 7 to 35, where higher scores means worse outcome.
Measure: Patient's fears towards COVID-19 Time: During medical visit, up to 1 hour
Description: Beliefs about Medicines Questionnaire, going from 11 to 55, with higher scores indicating stronger beliefs regarding medicine.
Measure: Patient's beliefs in their medicines towards COVID-19 Time: During medical visit, up to 1 hour
10 Impact of the Rheumatoid Factor on Serological Testing Performance for Covid-19 in Rheumatoid Arthritis Patients
Primary Outcomes
Description: ELISA tests for COVID-19 antibodies
Measure: COVID-19 seroconversion Time: 1 day, during routine blood collectionDescription: Case report form filled by the health professional
Measure: COVID-19 infection Time: During medical visit or phone consultation, up to 2 hoursSecondary Outcomes
Description: Descriptive analysis for each disease's rate
Measure: Seroconversion rate by disease Time: 1 day, during routine blood collectionDescription: Descriptive analysis for each country's rate
Measure: Penetration across Europe Time: 1 day, during routine blood collectionDescription: World Health Organization ordinal scale for clinical improvement at any given point of the infection, going from 0 to 8, where higher scores means worse outcome.
Measure: COVID-19 severity Time: During medical visit, up to 1 hourDescription: Descriptive analysis for overall and COVID-19-linked mortality rates
Measure: COVID-19 mortality rate Time: During contact with family members, up to 1 hourDescription: Case report form filled by the health professional
Measure: COVID-19 impact on immunomodulatory treatment Time: During medical visit, up to 1 hourDescription: Case report form filled by the patient
Measure: Patient-reported flares Time: During medical visit, up to 1 hourDescription: Fear of COVID-19 scale, going from 7 to 35, where higher scores means worse outcome.
Measure: Patient's fears towards COVID-19 Time: During medical visit, up to 1 hourDescription: Beliefs about Medicines Questionnaire, going from 11 to 55, with higher scores indicating stronger beliefs regarding medicine.
Measure: Patient's beliefs in their medicines towards COVID-19 Time: During medical visit, up to 1 hourDue to the Covid-19 worldwide outbreak, fragile patients with immune diseases, notably rheumatoid arthritis (RA), have to be even more specifically and carefully followed-up. However, it has been shown that false postive serological results often occured while detecting antibodies directed against SARS-CoV-2 in patients with positive rheumatodoid factor (RF). The investigators propose here to investigated this issue. Therefore, the investigators will test three different immunoassays on this specific population. The investigators aim to establish these assays specificity and the levels of RF for which there is a risk of anti-SARS-CoV-2 false positivity and thus ensure a better follow-up of RA patients. The RF isotype will be analysed to determine whether there is a correlation and the impact of the presence of anti-CCP (citrullinated cyclic antipeptide antibodies) will be studied and assessed.
NCT04407559 COVID-19 Rheumatoid Ar Rheumatoid Arthritis Other: Serological analyses to be lead on a pre-existing biobank MeSH:Arthritis Arthritis, Rheumatoid
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis
Primary Outcomes
Description: Evaluate the false positive results rate when using each one of the three SARS-CoV-2 serology tests in patients with rheumatoid factor plasma levels, so as to define the specificity of these tests in this RA population. all serum samples will be tested by the 3 different immunoassays. The RF plasma levels have already been measured (routine exam) and are written in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the question.
Measure: Evaluate the false positive results rate Time: 4 months
Secondary Outcomes
Description: Characterize the RF isotype (IgG, IgM or IgA) associated with the false positivity of the test.all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions
Measure: Characterize the RF isotype (IgG, IgM or IgA) associated Time: 4 months
Description: Determine the influence of RA on the false positivity rate in subjects with negative RF titer. All serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions
Measure: Determine the influence of RA on the false positivity rate in subjects Time: 4 months
Description: Assess the influence of the presence of anti-CCP on the false positivity of the SARS-CoV-2 test : all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions.
Measure: Assess the influence of the presence of anti-CCP on the false positivity of the SARS-CoV-2 test Time: 4 months
Description: Assess the relation between the RF plasma levels and the false positivity of the SARS-CoV-2 test : all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions.
Measure: Assess the relation between the RF plasma levels and the false positivity of the SARS-CoV-2 test Time: 4 months
11 Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context
Primary Outcomes
Description: Evaluate the false positive results rate when using each one of the three SARS-CoV-2 serology tests in patients with rheumatoid factor plasma levels, so as to define the specificity of these tests in this RA population. all serum samples will be tested by the 3 different immunoassays. The RF plasma levels have already been measured (routine exam) and are written in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the question.
Measure: Evaluate the false positive results rate Time: 4 monthsSecondary Outcomes
Description: Characterize the RF isotype (IgG, IgM or IgA) associated with the false positivity of the test.all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions
Measure: Characterize the RF isotype (IgG, IgM or IgA) associated Time: 4 monthsDescription: Determine the influence of RA on the false positivity rate in subjects with negative RF titer. All serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions
Measure: Determine the influence of RA on the false positivity rate in subjects Time: 4 monthsDescription: Assess the influence of the presence of anti-CCP on the false positivity of the SARS-CoV-2 test : all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions.
Measure: Assess the influence of the presence of anti-CCP on the false positivity of the SARS-CoV-2 test Time: 4 monthsDescription: Assess the relation between the RF plasma levels and the false positivity of the SARS-CoV-2 test : all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions.
Measure: Assess the relation between the RF plasma levels and the false positivity of the SARS-CoV-2 test Time: 4 monthsThe current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is concerns by these fears (the patient and their parents). Patients are treated by several classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs, corticosteroids and disease modifying anti-rheumatic drugs. The present study will characterize this issue by defining the proportion of patients whose usual treatment of Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis, and also to return to school.
NCT04407923 Juvenile Idiopathic Arthritis COVID 19 Treatment MeSH:Arthritis Arthritis, Juvenile
HPO:Arthritis Polyarticular arthritis
Primary Outcomes
Description: Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD
Measure: Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis Time: 1 Day
12 Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study
Primary Outcomes
Description: Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD
Measure: Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis Time: 1 DayRheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus, the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among RA patients.
NCT04434118 Rheumatoid Arthritis COVID Drug: Traditional antirheumatic drugs MeSH:Arthritis Arthritis, Rheumatoid
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis
Primary Outcomes
Description: Realtion between hydroxychloroquine use and COVID-19 infection
Measure: The risk of COVID-19 infection among RA patients Time: 12 week
Secondary Outcomes
Description: Number of cases and number of hospitalization days
Measure: The incidence of hospitalization for Covid-19 patients. Time: 12 week
HPO Nodes
HP:0001369: Arthritis
Genes 263
CCN6 IL2RA NFKBIL1 LBR SPTB BLNK TRAPPC2 EPB42 MVK CD79A IL36RN COMP STAT3 IL2RB TGFB3 MEFV IL12A-AS1 CASP10 MLX MMP13 SLCO2A1 COL2A1 COL2A1 ASAH1 IGHM COL2A1 APOE HNF4A COL2A1 ADA2 PTPN22 MMP14 NOD2 CD247 BTK SCARB2 COL2A1 GLA UMOD CCR1 COL11A2 LRBA CCR6 COMP EXT1 IL6 RREB1 KLRC4 COL11A1 PTPN22 PSTPIP1 HNF1B SAMHD1 HLA-C COL11A2 LRP6 GPR101 COL2A1 RAG1 KIF7 DCLRE1C NOD2 CTLA4 NLRP3 HPRT1 ABCG8 HGD MMP13 HLA-DRB1 NLRP3 SH3KBP1 SLC37A4 TF CCN6 ZNF687 GJB2 IL2RA PFKM AIP FASLG TREX1 HLA-B MATN3 ASPN TNFRSF1A C4A COL2A1 MYH14 UBAC2 FAS ARVCF ACP5 EXT2 PRG4 AEBP1 MTHFD1 ANKRD55 PTPN22 TFR2 GCH1 GJB6 COL9A1 COL11A2 PTPN22 SPP1 RNASEH2B TRAPPC2 OCRL TREX1 LRRC8A GBA COL1A1 LMX1B ACAN GP1BB TLR4 ANK1 COMP UFD1 SLC12A3 NLRP3 FAS HGD IL12A SEC61A1 PHEX COPA HPGD IRF5 FCGR2B TRPV4 PSMB9 WIPF1 CTLA4 CAV1 MVK HLA-DRB1 ATP7B MUC1 COL9A1 ACAN ATP7B EPCAM DNASE1L3 CLCNKB LMNA MMP2 IL10 IL12B RASGRP1 PTPN2 COMT COL2A1 STAT4 SLC37A4 GNAS MIF HLA-DRB1 WAS STAT4 RNF168 CLCN7 JMJD1C IL23R MEFV G6PC CFI ERAP1 F8 PSTPIP1 GHR HLA-B HIRA PRPS1 ADAR DNAJB11 MEFV PTPN2 IL10 ANKH IFIH1 STAT4 COL5A1 FRZB HPGD KIF22 TBX1 CIITA CD79B IGLL1 IRAK1 IL2RB MATN3 COL9A2 COL9A3 TNFRSF11B COMP HLA-B STAT4 PADI4 MATN3 HJV COL2A1 SMAD3 F9 TRPS1 UFSP2 RAG2 COL1A1 MEFV COL5A1 ANKRD55 SLC40A1 SLC4A1 SPTA1 FBN1 BTK RNASEH2C DNASE1 CANT1 TBX1 PHEX CD247 TCF3 PSMB4 PIK3R1 AGA CD244 COL5A2 LEMD3 FGFR3 RNASEH2A ACAN HPRT1 ANKH SEC24C GDF5 SLC22A4 UMOD HPRT1 TRPV4 HPGD BTK FAS COL9A3 UFSP2 ZMPSTE24 PTPN22 LACC1 HPRT1 NLRP3 HNF1B HOXD10 PRKCD SLC26A2 COL9A2 SMAD3 FCGR2A CCN2 CLCN7 COL3A1 ASAH1 NLRP12
Primary Outcomes
Description: Realtion between hydroxychloroquine use and COVID-19 infection
Measure: The risk of COVID-19 infection among RA patients Time: 12 weekSecondary Outcomes
Description: Number of cases and number of hospitalization days
Measure: The incidence of hospitalization for Covid-19 patients. Time: 12 week