CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D015535: Arthritis, Psoriatic NIH

(Synonyms: Arthritis, Psor, Arthritis, Psoriati, Arthritis, Psoriatic)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (10)


Name (Synonyms) Correlation
drug1332 Hydroxychloroquine/Chloroquine Wiki 0.50
drug151 Adalimumab Wiki 0.50
drug2166 Placebo to match filgotinib Wiki 0.50
drug1106 Filgotinib Wiki 0.50
drug562 COVID-19 infection Wiki 0.50
drug2165 Placebo to match adalimumab Wiki 0.50
drug2314 Questionnaire by phone call Wiki 0.50
drug534 COVID-19 Breastfeeding Support Wiki 0.50
drug535 COVID-19 Convalescent Plasma Wiki 0.45
drug531 COVID-19 Wiki 0.35

Correlated MeSH Terms (12)


Name (Synonyms) Correlation
D001168 Arthritis NIH 0.55
D008180 Lupus Erythematosus, Systemic NIH 0.41
D001167 Arteritis NIH 0.35
D012859 Sjogren's Syndrome NIH 0.35
D011111 Polymyalgia Rheumatica NIH 0.29
D013700 Giant Cell Arteritis NIH 0.29
D003095 Collagen Diseases NIH 0.25
D001327 Autoimmune Diseases NIH 0.25
D012216 Rheumatic Diseases NIH 0.20
D001172 Arthritis, Rheumatoid NIH 0.18
D003141 Communicable Diseases NIH 0.04
D007239 Infection NIH 0.03

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0001369 Arthritis HPO 0.55
HP:0002725 Systemic lupus erythematosus HPO 0.41
HP:0012089 Arteritis HPO 0.35
HP:0002960 Autoimmunity HPO 0.25
HP:0001370 Rheumatoid arthritis HPO 0.18

There are 4 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

The 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

This 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

This 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


HPO Nodes