Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
Primary Objective:

To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.

Secondary Objective:

To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.

Detailed description:
Total study duration was up to 62 weeks: Up to 4-week screening period, 52-week treatment period, and 6-week post-treatment follow-up period.

Arms:
arm 1: Participants received sarilumab 150 mg, subcutaneous (SC) injection, once every two weeks (q2w) along with non-MTX DMARDs (sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine) for up to 52 weeks. arm 2: Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs (sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine) for up to 52 weeks. arm 3: Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks. arm 4: Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.

Interventions: intervention 1: Sarilumab intervention 2: Sulfasalazine intervention 3: Leflunomide intervention 4: Bucillamine intervention 5: Tacrolimus intervention 6: Mizoribine
Intervention descriptions: intervention 1: Pharmaceutical form:solution intervention 2: Pharmaceutical form: Tablet Route of administration: Oral intervention 3: Pharmaceutical form: Tablet Route of administration: Oral intervention 4: Pharmaceutical form: Tablet Route of administration: Oral intervention 5: Pharmaceutical form: Capsule Route of administration: Oral intervention 6: Pharmaceutical form: Tablet Route of administration: Oral

Protocol document: