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    HP:0001369: Arthritis

    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 (28)


    Name (Synonyms) Correlation
    drug576 C21 Wiki 0.29
    drug578 C3+ Holter Monitor Wiki 0.29
    drug597 CGB-S-100 Wiki 0.29
    Name (Synonyms) Correlation
    drug1569 Hydroxychloroquine/Chloroquine Wiki 0.29
    drug1939 MSB11456 Wiki 0.29
    drug4040 placebo rinse Wiki 0.29
    drug601 CHX0.12+CPC0.05 oral rinse (PerioAidActive Control) Wiki 0.29
    drug661 COVID-19 infection Wiki 0.29
    drug599 CHLORPROMAZINE (CPZ) Wiki 0.29
    drug48 40ml blood sample Wiki 0.29
    drug3095 Serological analyses to be lead on a pre-existing biobank Wiki 0.29
    drug560 Bromhexine 8 MG Wiki 0.29
    drug588 CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc Wiki 0.29
    drug2692 Psychoeducation and Safety Wiki 0.29
    drug589 CD24Fc Wiki 0.29
    drug582 CAP-1002 Allogeneic Cardiosphere-Derived Cells Wiki 0.29
    drug586 CCP Wiki 0.29
    drug594 CETA Short Session (CSS) Wiki 0.29
    drug1140 EU-approved RoActemra Wiki 0.29
    drug3506 Traditional antirheumatic drugs Wiki 0.29
    drug2744 Questionnaire by phone call Wiki 0.29
    drug567 Bucillamine Wiki 0.20
    drug2519 Placebo Administration Wiki 0.14
    drug4071 questionnaire assesment Wiki 0.13
    drug3223 Standard of Care (SOC) Wiki 0.13
    drug1538 Hydroxychloroquine Sulfate Wiki 0.08
    drug2505 Placebo Wiki 0.04
    drug1520 Hydroxychloroquine Wiki 0.03

    Correlated MeSH Terms (16)


    Name (Synonyms) Correlation
    D001168 Arthritis NIH 0.89
    D001172 Arthritis, Rheumatoid NIH 0.70
    D015535 Arthritis, Psoriatic NIH 0.50
    Name (Synonyms) Correlation
    D001167 Arteritis NIH 0.41
    D008180 Lupus Erythematosus, Systemic NIH 0.35
    D011111 Polymyalgia Rheumatica NIH 0.33
    D013700 Giant Cell Arteritis NIH 0.33
    D001171 Arthritis, Juvenile NIH 0.29
    D025241 Spondylarthritis NIH 0.29
    D012859 Sjogren's Syndrome NIH 0.29
    D001327 Autoimmune Diseases NIH 0.26
    D003095 Collagen Diseases NIH 0.24
    D012216 Rheumatic Diseases NIH 0.20
    D059350 Chronic Pain NIH 0.09
    D003141 Communicable Diseases NIH 0.02
    D007239 Infection NIH 0.01

    Correlated HPO Terms (5)


    Name (Synonyms) Correlation
    HP:0001370 Rheumatoid arthritis HPO 0.82
    HP:0012089 Arteritis HPO 0.41
    HP:0002725 Systemic lupus erythematosus HPO 0.39
    Name (Synonyms) Correlation
    HP:0002960 Autoimmunity HPO 0.29
    HP:0012532 Chronic pain HPO 0.10

    Clinical Trials

    Navigate: Correlations   HPO

    There are 12 clinical trials


    1 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
    Conditions
    1. Rheumatoid Arthritis
    2. Psoriatic Arthritis
    3. Axial Spondyloarthritis
    4. Systemic Lupus Erythematosus
    5. Giant Cell Arteritis
    Interventions
    1. 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
    2 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
    Conditions
    1. SARS-CoV-2
    2. Systemic Lupus Erythematosus
    3. Rheumatoid Arthritis
    4. Sjogren's Syndrome
    5. Psoriatic Arthritis
    Interventions
    1. 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
    3 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
    4 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
    5 Immune Cells and the Coronavirus for Inflammatory Arthritis

    A 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
    Conditions
    1. SARS Virus
    Interventions
    1. 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
    6 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
    7 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
    8 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
    9 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
    10 Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context

    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. 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
    Conditions
    1. Juvenile Idiopathic Arthritis
    2. COVID 19
    3. 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
    11 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
    12 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

    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
    Protein Mutations 4
    A147T N363S R620W V600E

    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    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
    Protein Mutations 4
    A147T N363S R620W V600E

    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.

    Drug Reports   MeSH Reports   HPO Reports  

    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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