A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY ASSESSING THE EFFICACY AND SAFETY OF SARILUMAB MONOTHERAPY VERSUS ADALIMUMAB MONOTHERAPY IN PATIENTS WITH RHEUMATOID.
- Conditions
- -M069M069
- Registration Number
- PER-081-14
- Lead Sponsor
- Sanofi Aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 18
At both Screening and Baseline:
• Diagnosis of rheumatoid arthritis ≥3 months duration, according to the American College of Rheumatology (ACR)/European League against
Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria (1)
• ACR Class I-III functional status, based on 1991 revised criteria (2)
• Active RA defined as:
- At randomization: at least 6 of 66 swollen joints and 8 of 68 tender joints
- Between screening and randomization: High sensitivity C-reactive protein (hs-CRP) ≥8 mg/L or ESR ≥28 mm/H.
- At randomization: DAS28ESR > 5.1 using an ESR assessed between screening and randomization.
• Patients who per investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, or inadequate responders treated with an adequate MTX dose (10 to 25 mg/wk, or 6 to 25 mg/wk for patients within Asia-Pacific region) for at least 12 weeks.
• Patients must have signed a written informed consent prior to performance of any study-related procedures
• Age <18 years or the legal age of consent in the country of the study site, whichever is higher.
• Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL- 6 receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor.
• Current treatment with DMARDS / immunosuppressive agents including MTX,
cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (Randomization Visit) or leflunomide within 8 weeks prior to the Randomization Visit, or 4 weeks after standard cholestyramine washout:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method