Clinical trial NCT01061736
Conditions: Rheumatoid Arthritis
Sponsor: Sanofi
Start date: 2010-03-01; Completion date: 2013-10-01
Enrollment: 1675 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objectives:

Part A (dose ranging study):

To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.

Part B (pivotal study):

To demonstrate that sarilumab added to MTX was effective in:

* reduction of signs and symptoms of rheumatoid arthritis at 24 weeks
* inhibition of progression of structural damage at 52 weeks
* improvement in physical function at 16 weeks

Secondary Objectives:

Part B:

To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks

To assess the safety of sarilumab added to MTX

To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.

Detailed description:
The total study duration for a participant was 16-22 weeks (Part A) and 56-62 weeks (Part B) broken down as follows:

* Screening: Up to 4 weeks
* Treatment: 12 weeks (Part A) and 52 weeks (Part B)\*
* Follow-up: 6 weeks (for participants who would not continue in the long-term extension study).

'\*' Participants successfully completing their treatment period would be offered the opportunity to enter the long term extension study LTS11210 (SARIL-RA-EXTEND) (NCT01146652).

Arms: arm 1: Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of MTX for 12 weeks. arm 2: Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks. arm 3: Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks. arm 4: Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks. arm 5: Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks. arm 6: Placebo (for sarilumab) qw on top of MTX for 12 weeks. arm 7: Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210). arm 8: Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab. arm 9: Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab. arm 10: Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.
Interventions: intervention 1: Sarilumab intervention 2: Placebo (for sarilumab) intervention 3: Methotrexate intervention 4: Folic 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: Same weekly dose as received prior to enrollment intervention 4: According to local standard

Protocol documents: