Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 202
Healthy volunteers: no

Brief summary:
Primary Objective:

To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

Detailed description:
Total study duration was up to 34 weeks: Screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks.

After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).

Arms:
arm 1: Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. arm 2: Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. arm 3: Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.

Interventions: intervention 1: sarilumab SAR153191 (REGN88) intervention 2: tocilizumab intervention 3: hydroxychloroquine intervention 4: methotrexate intervention 5: sulfasalazine intervention 6: leflunomide intervention 7: subcutaneous placebo intervention 8: intravenous placebo
Intervention descriptions: intervention 1: Pharmaceutical form: solution Route of administration: subcutaneous intervention 2: Pharmaceutical form: solution Route of administration: intravenous intervention 3: Dispensed according to local practice. intervention 4: Dispensed according to local practice. intervention 5: Dispensed according to local practice. intervention 6: Dispensed according to local practice. intervention 7: Pharmaceutical form: solution Route of administration: subcutaneous intervention 8: Pharmaceutical form: solution Route of administration: intravenous

Protocol document: