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D001172: Arthritis, Rheumatoid

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (27)


Name (Synonyms) Correlation
drug604 CK0802 Wiki 0.30
drug578 C3+ Holter Monitor Wiki 0.30
drug1569 Hydroxychloroquine/Chloroquine Wiki 0.30
Name (Synonyms) Correlation
drug1939 MSB11456 Wiki 0.30
drug4040 placebo rinse Wiki 0.30
drug601 CHX0.12+CPC0.05 oral rinse (PerioAidActive Control) Wiki 0.30
drug217 Alternating face-to-face medical visits and video medical consultations Wiki 0.30
drug599 CHLORPROMAZINE (CPZ) Wiki 0.30
drug606 CLIA of IgG and IgM against SARS-Cov-2 Wiki 0.30
drug3095 Serological analyses to be lead on a pre-existing biobank Wiki 0.30
drug1288 Face-to-face medical visits Wiki 0.30
drug588 CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc Wiki 0.30
drug605 CLBS119 Wiki 0.30
drug2692 Psychoeducation and Safety Wiki 0.30
drug3171 Sofusa DoseConnect Wiki 0.30
drug589 CD24Fc Wiki 0.30
drug582 CAP-1002 Allogeneic Cardiosphere-Derived Cells Wiki 0.30
drug594 CETA Short Session (CSS) Wiki 0.30
drug1186 Enbrel Wiki 0.30
drug1140 EU-approved RoActemra Wiki 0.30
drug3506 Traditional antirheumatic drugs Wiki 0.30
drug567 Bucillamine Wiki 0.21
drug2519 Placebo Administration Wiki 0.15
drug4071 questionnaire assesment Wiki 0.13
drug3223 Standard of Care (SOC) Wiki 0.13
drug2505 Placebo Wiki 0.04
drug1520 Hydroxychloroquine Wiki 0.03

Correlated MeSH Terms (14)


Name (Synonyms) Correlation
D001168 Arthritis NIH 0.86
D025241 Spondylarthritis NIH 0.30
D001167 Arteritis NIH 0.21
Name (Synonyms) Correlation
D015535 Arthritis, Psoriatic NIH 0.17
D011111 Polymyalgia Rheumatica NIH 0.17
D013700 Giant Cell Arteritis NIH 0.17
D012859 Sjogren's Syndrome NIH 0.15
D001327 Autoimmune Diseases NIH 0.13
D003095 Collagen Diseases NIH 0.12
D008180 Lupus Erythematosus, Systemic NIH 0.12
D012216 Rheumatic Diseases NIH 0.11
D059350 Chronic Pain NIH 0.09
D003141 Communicable Diseases NIH 0.02
D007239 Infection NIH 0.02

Correlated HPO Terms (6)


Name (Synonyms) Correlation
HP:0001370 Rheumatoid arthritis HPO 0.85
HP:0001369 Arthritis HPO 0.70
HP:0012089 Arteritis HPO 0.21
Name (Synonyms) Correlation
HP:0002960 Autoimmunity HPO 0.15
HP:0002725 Systemic lupus erythematosus HPO 0.13
HP:0012532 Chronic pain HPO 0.10

Clinical Trials

Navigate: Correlations   HPO

There are 11 clinical trials


1 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
Conditions
  1. Covid-19 Infection
  2. Rheumatoid Arthritis
  3. Psoriatic Arthritis
  4. Hydroxychloroquine
Interventions
  1. 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
2 Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak

Clinical 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
Conditions
  1. Sars-CoV2
  2. Rheumatic Diseases
  3. Rheumatoid Arthritis
  4. Chronic Pain
Interventions
  1. 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
3 Antimalarial and Covid 19 in Rheumatoid Arthritis

The 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
Conditions
  1. Rheumatoid Arthritis
Interventions
  1. Drug: Hydroxychloroquine
MeSH:Arthritis Arthritis, Rheumatoid
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis

Primary Outcomes

Description: serum level

Measure: immunoglobulin mesurement

Time: 1 month
4 Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation

The 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
Conditions
  1. Rheumatoid Arthritis
  2. 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
5 Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe

The 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
Conditions
  1. COVID-19
  2. Systemic Lupus Erythematosus
  3. Sjogren's Syndrome
  4. Axial Spondyloarthritis
  5. Rheumatoid Arthritis
  6. 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
6 Impact of the Rheumatoid Factor on Serological Testing Performance for Covid-19 in Rheumatoid Arthritis Patients

Due 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
Conditions
  1. COVID-19
  2. Rheumatoid Ar
  3. Rheumatoid Arthritis
Interventions
  1. 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
7 Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study

Rheumatoid 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
Conditions
  1. Rheumatoid Arthritis
  2. COVID
Interventions
  1. 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
8 A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union-approved RoActemra® in Patients With Moderately to Severely Active Rheumatoid Arthritis (APTURA I Study)

The purpose of the study is to compare the efficacy, safety and immunogenicity of MSB11456 and EU approved RoActemra® in participants with moderately to severely active rheumatoid arthritis. Participants will be randomized at the beginning of the Core Treatment Period (Baseline to Week 24) to receive either MSB11456 or EU approved RoActemra® once a week (QW). At the beginning of the Extended Treatment Period (Week 24 to Week 52), participants who received RoActemra® will be re-randomized to either continue receiving RoActemra® QW or switch to receive MSB11456 QW.

NCT04512001
Conditions
  1. Rheumatoid Arthritis
Interventions
  1. Drug: MSB11456
  2. Drug: EU-approved RoActemra
MeSH:Arthritis Arthritis, Rheumatoid
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis

Primary Outcomes

Measure: Change from Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)

Time: Baseline; Week 24

Secondary Outcomes

Measure: Change from Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)

Time: Baseline; Week 52

Measure: Number of Participants with 20% Improvement in American College of Rheumatology (ACR20) Response

Time: Week 24

Measure: Number of Participants who Experienced One or More Treatment-Emergent Adverse Event (TEAE)

Time: Baseline to end of study, up to Week 63

Measure: Number of Participants who Experienced One or More Serious Adverse Event (SAE)

Time: Baseline to end of study, up to Week 63

Measure: Number of Participants with Positive Anti-Drug Antibodies (ADAs)

Time: Week 2; Week 55

Measure: Anti-Drug Antibodies (ADAs) Titer Levels

Time: Week 2; Week 55

Measure: Number of Participants with Confirmed Neutralizing Antibodies (NAb)

Time: Week 2; Week 55
9 Seroprevalence and Clinical Expression of SARS-CoV-2 Infection in Patients With Chronic Inflammatory Rheumatisms and Impact of Immuno-suppressive Drugs on the Persistence of Anti-SARS-CoV2 Antibodies During Two Years of Follow-up

A better understanding of the different phenotypes of COVID 19 in patients with inflammatory rheumatisms, and the persitence of antibodies against SARS CoV-2 in these patients under immunosuppressive drugs are required to propose appropriated recommendations for these patients in order to guide the strategy of vaccination in this immune-depressed population who is not immunized.

NCT04530682
Conditions
  1. Rheumatoid Arthritis
MeSH:Arthritis Arthritis, Rheumatoid
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis

Primary Outcomes

Description: Variation of anti-SARS-CoV2 antibodies titers between baseline

Measure: Seroprevalence of COVID-19 in patients with inflammatory rheumatisms

Time: 6 months

Description: Variation of anti-SARS-CoV2 antibodies titers between baseline

Measure: Seroprevalence of COVID-19 in patients with inflammatory rheumatisms

Time: 12 months

Secondary Outcomes

Description: Coagulation factors in patients with inflammatory rheumatisms compared to health professionals

Measure: Clinical expression of COVID-19 compared to health professionals : phenotypes, thrombo-embolic events and stress repercussion

Time: 6 months

Description: Coagulation factors in patients with inflammatory rheumatisms compared to health professionals

Measure: Clinical expression of COVID-19 compared to health professionals : phenotypes, thrombo-embolic events and stress repercussion

Time: 12 months

Description: Coagulation factors in patients with inflammatory rheumatisms compared to health professionals

Measure: Clinical expression of COVID-19 compared to health professionals : phenotypes, thrombo-embolic events and stress repercussion

Time: 24 months
10 Impact of a Hybrid Medical Care Model (Face-to-face Medical Visits Alternating With Video Medical Consultations) in the Rheumatoid Arthritis Patient-reported-outcomes Measures: A Non-inferiority Study

The COVID-19 outbreak has affected health care of patients with rheumatic diseases; telemedicine might help to assist patients. The primary objective is to determine if a hybrid medical care model, which consists of alternating face-to-face medical visits and video medical consultations, is not inferior, in terms of the Patient Reported Outcomes measures (PROMs), to the face-to-face medical care model, among rheumatoid arthritis (RA) outpatients. We also aim to investigate if adherence to RA-related treatment (considered a surrogate of patient´s education) might be improved when patients are re-integrated to the health care system, irrespective of the health care model. In Mexico, COVID-19 pandemic still uncontrolled. Our Institution provides health care to 1500 RA patients/year and up to August 2020, it is estimated that 500 RA patients might be affected, which is our target audience. Reinstalling institutional health care provision is challenging. This a non-inferiority, cross-over study, with 2 intervention arms. Patients will be randomized to 1. Six months of usual medical care model, followed by 4 months of a control period, and 6 months of hybrid medical care model, or 2. Six months of hybrid medical care model, followed by 4 months of a control period, and 6 months of usual medical care model. The following PROMs will be assessed at specific time points: disease activity/disease severity (RAPID-3), disability (HAQ-DI), quality of life (WHOQOL-BREF), patient satisfaction with the medical care model (questionnaire locally developed), patient´s adherence to medical care (missed scheduled visits) and patient´s adherence to RA-related treatment (the Compliance-Questionnaire).

NCT04558905
Conditions
  1. Rheumatoid Arthritis
  2. Telehealth
Interventions
  1. Other: Face-to-face medical visits
  2. Other: Alternating face-to-face medical visits and video medical consultations
MeSH:Arthritis Arthritis, Rheumatoid
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis

Primary Outcomes

Description: The disease activity measured by a RAPID-3 instrument

Measure: Rheumatoid arthritis patient´s disease activity

Time: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)

Description: Quality of life measured by a WHOQOL-BREF instrument

Measure: Rheumatoid arthritis patient´s quality of life

Time: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)

Description: Disability measured by a HAQ-DI instrument

Measure: Rheumatoid arthritis patient's disability

Time: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)

Secondary Outcomes

Description: Questionnaire locally developed

Measure: Satisfaction with medical care

Time: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)

Description: Number of missed scheduled visits

Measure: Patient´s adherence to medical care

Time: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
11 Phase 1b Proof-of-concept, Open-label Study to Assess the Safety and Pilot Efficacy of Enbrel® Administered by the Sofusa® DoseConnect™ Delivery System for the Treatment of Rheumatoid Arthritis

This is an open-label pilot study in patients with rheumatoid arthritis (RA). All patients will receive SOFUSA Enbrel 25 mg once weekly. The dose will be increased to 50 mg if the dose escalation criteria are met during the dose escalation phase of the study.

NCT04559412
Conditions
  1. Rheumatoid Arthritis
Interventions
  1. Device: Sofusa DoseConnect
  2. Drug: Enbrel
MeSH:Arthritis Arthritis, Rheumatoid
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis

Primary Outcomes

Description: Incidence and severity of adverse events and their relationships to SOFUSA administration

Measure: Incidence and severity of adverse events and their relationships to SOFUSA administration

Time: Baseline through Week 12

Secondary Outcomes

Description: Change from Baseline in DAS28(CRP) score at Week 12

Measure: Change in Disease Activity Score 28-joint count C reactive protein (DAS28(CRP))

Time: Baseline to Week 12

Description: Change from Baseline in DAS28(CRP) score over time

Measure: Change in DAS28(CRP) score over time

Time: Baseline through Week 12

Description: Change from Baseline in DAS28(ESR) score over time

Measure: Change in Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28(ESR)) over time

Time: Baseline through Week 12

Description: Change from Baseline in SDAI score over time

Measure: Change in Simplified Disease Activity Index (SDAI) score over time

Time: Baseline through Week 12

Description: Change from Baseline in CDAI score over time

Measure: Change in Clinical Disease Activity Index (CDAI) score over time

Time: Baseline through Week 12

Description: Proportion of patients with DAS28(CRP) score < 2.9 over time

Measure: Proportion of patients with low disease activity (LDA) over time as assessed by the DAS28(CRP)

Time: Baseline through Week 12

Description: Proportion of patients with DAS28(ESR) score ≤ 3.2 over time

Measure: Proportion of patients with LDA over time as assessed by the DAS28(ESR)

Time: Baseline through Week 12

Description: Proportion of patients with SDAI score ≤ 11.0 over time

Measure: Proportion of patients with LDA over time as assessed by the SDAI

Time: Baseline through Week 12

Description: Proportion of patients with CDAI score ≤ 10 over time

Measure: Proportion of patients with LDA over time as assessed by the CDAI

Time: Baseline through Week 12

Description: Proportion of patients achieving ACR20/50/70 response over time

Measure: Proportion of patients achieving ACR20/50/70 response over time

Time: Baseline through Week 12

Description: Proportion of patients achieving moderate or good EULAR response over time

Measure: Proportion of patients achieving moderate or good EULAR response over time

Time: Baseline through Week 12

Description: Proportion of patients achieving a MCID of 0.22 in HAQ-DI over time

Measure: Proportion of patients achieving a minimally clinically important difference (MCID) of 0.22 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) over time

Time: Baseline through Week 12

HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

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