A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

sanofi-aventis recherche & développement0 个研究点目标入组 340 人开始时间: 2014年12月22日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Diagnosis of rheumatoid arthritis ?3 months duration.
•American College of Rheumatology (ACR) Class I-III functional status.
•Active RA, defined as:
•- At least 6 of 66 swollen joints and 8 of 68 tender joints,
•- High sensitivity C-reactive protein (hs-CRP)?8 mg/L or ESR?28 mm/H, and
•- DAS28ESR >5.1.
•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 for at least 12 weeks.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 230
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 110

•Age <18 years or the legal age of consent in the country of the study site, whichever is higher.
•Current treatment with disease-modifying antirheumatic drug (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 cholestyramine washout.
•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.
•Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening.

发起方