An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Placebo (for etanercept)Drug: Placebo (for sarilumab)
- Registration Number
- NCT01764997
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 776
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sarilumab 150 mg + MTX (Randomized) Sarilumab 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. Adalimumab Open Label run-in Adalimumab Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX. Sarilumab 150 mg + MTX (Randomized) Methotrexate 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. Sarilumab 150 mg + MTX (Randomized) Placebo (for etanercept) 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. Etanercept + MTX (Randomized) Etanercept 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. Etanercept + MTX (Randomized) Methotrexate 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. Etanercept + MTX (Randomized) Placebo (for sarilumab) 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. Sarilumab 200 mg + MTX (Randomized) Placebo (for etanercept) 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. Sarilumab 150 mg + MTX Open Label Sub-study Sarilumab Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX. Adalimumab Open Label run-in Methotrexate Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX. Sarilumab 200 mg + MTX (Randomized) Sarilumab 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. Sarilumab 200 mg + MTX (Randomized) Methotrexate 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. Sarilumab 150 mg + MTX Open Label Sub-study Methotrexate Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.
- Primary Outcome Measures
Name Time Method Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24 Baseline, Week 24
- Secondary Outcome Measures
Name Time Method Number of Participants With at Least 20% Improvement in American College of Rheumatology (ACR20), at Least 50% Improvement in ACR (ACR50) and at Least 70% Improvement in ACR (ACR70) Efficacy Response Rates at Week 12 and Week 24 Week 12 and Week 24 Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24 Week 12 and Week 24 Change From Baseline in DAS28-CRP Score at Week 12 Baseline, Week 12
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Trial Locations
- Locations (257)
Investigational Site Number 840004
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840212
🇺🇸Glendale, California, United States
Investigational Site Number 840211
🇺🇸Thousand Oaks, California, United States
Investigational Site Number 840049
🇺🇸Upland, California, United States
Investigational Site Number 840205
🇺🇸Victorville, California, United States
Investigational Site Number 840201
🇺🇸Denver, Colorado, United States
Investigational Site Number 840209
🇺🇸Danbury, Connecticut, United States
Investigational Site Number 840203
🇺🇸Washington, D.C., District of Columbia, United States
Investigational Site Number 840210
🇺🇸Clearwater, Florida, United States
Investigational Site Number 840128
🇺🇸Ormond Beach, Florida, United States
Scroll for more (247 remaining)Investigational Site Number 840004🇺🇸Birmingham, Alabama, United States