Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief summary:
Primary Objective:

\- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists.

Secondary Objectives:

* To assess the safety of sarilumab;
* To document the pharmacokinetic profile of sarilumab.

Detailed description:
The duration of the study period for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period.

Participants who completed the 12-week treatment period were offered enrollment in a separate long-term extension study (LTS11210/NCT01146652).

Arms:
arm 1: Placebo 2 mL to match sarilumab once a week (qw) and 0.5 mL to match golimumab every 4 weeks (q4w) on top of MTX (15-25 mg) qw for 12 weeks. arm 2: Golimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks. arm 3: Sarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks.

Interventions: intervention 1: Sarilumab intervention 2: Placebo intervention 3: Golimumab intervention 4: methotrexate (MTX) intervention 5: Folic/folinic acid
Intervention descriptions: intervention 1: Pharmaceutical form: solution for injection

Route of administration: subcutaneous intervention 2: Pharmaceutical form: solution for injection

Route of administration: subcutaneous intervention 3: Pharmaceutical form: solution for injection

Route of administration: subcutaneous intervention 4: Pharmaceutical form: tablet or solution for injection

Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution) intervention 5: Pharmaceutical form: tablet

Route of administration: oral Folic/folinic acid continued according to local standard.

Protocol document: