A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY ASSESSING THE EFFICACY AND SAFETY OF SARILUMAB MONOTHERAPY VERSUS ADALIMUMAB MONOTHERAPY IN PATIENTS WITH RHEUMATOID.

Sanofi Aventis Recherche & Development,0 个研究点目标入组 18 人开始时间: 2015年4月30日最近更新: 2023年9月4日

试验速览

暂无简介。

•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:

发起方

Sanofi Aventis Recherche & Development,