Clinical trial NCT01764997
Conditions: Rheumatoid Arthritis
Sponsor: Sanofi
Start date: 2013-04-01; Completion date: 2015-01-01
Enrollment: 776 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.

To assess the quality of life of participants with RA taking sarilumab in combination with MTX.

To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

Detailed description:
The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the randomized phase of main study was 54 weeks:

* open label screening period of up to 4 weeks
* open-label treatment period of 16 weeks
* randomized screening period of 2 to 4 weeks
* randomized treatment post-treatment safety follow-up period of 6 weeks.

The maximum study duration per participant enrolled only in the open label run-in phase and was not eligible to enroll in the randomized phase of main study was 26 weeks:

* open label screening period of up to 4 weeks
* open-label treatment period of 16 weeks
* open label treatment post-treatment safety follow-up period of 6 weeks.

The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the sarilumab sub-study was 82 weeks:

* open label screening period of up to 4 weeks
* open-label treatment period of 16 weeks
* screening period of 2 to 4 weeks
* sarilumab treatment period of 52 weeks
* sub-study post-treatment safety follow-up period of 6 weeks.

Arms: arm 1: Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX. arm 2: Etanercept 50 mg in combination with Placebo for sarilumab Q2W and etanercept 50 mg on alternating weeks for 24 weeks added to stable dose of MTX. arm 3: Sarilumab 150 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. arm 4: Sarilumab 200 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. arm 5: Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.
Interventions: intervention 1: Sarilumab intervention 2: Etanercept intervention 3: Methotrexate intervention 4: Placebo (for sarilumab) intervention 5: Placebo (for etanercept) intervention 6: Adalimumab
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous intervention 2: Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous intervention 3: Dispensed according to local practice. intervention 4: None intervention 5: None intervention 6: Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

Protocol documents: