An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
- Conditions
- Rheumatoid ArthritisMedDRA version: 15.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2012-001984-66-GB
- Lead Sponsor
- sanofi-aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 776
Diagnosis of rheumatoid arthritis (RA) >/= 3 months duration.
Continuous treatment of methotrexate (MTX) 10 - 25 mg/week (or per local labeling requirements if the dose range differs) for at least 12 weeks before screening visit and on a stable dose for 8 weeks before screening visit.
Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high sensitivity C-reactive protein > 10 mg/L.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2060
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 540
Age < 18 years.
Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks of the screening visit.
Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks of the screening visit.
Prior treatment with a TNF (tumor necrosis factor)-alpha inhibitor, or other biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.
New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 inhibitors (COX-2 inhibitors within 4 weeks of the screening visit.
Treatment with traditional oral disease-modifying antirheumatic drugs (DMARD) /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity Score for 28 joints (DAS28);<br> Secondary Objective: To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab in combination with methotrexate (MTX)<br> To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in combination with methotrexate (MTX)<br> To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA)<br> ;Primary end point(s): Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP score) score change from baseline (randomized treatment phase);Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method <br> Timepoint(s) of evaluation of this end point: Week 24 for items 1 and 2<br> Week 12 for item 3<br> ;<br> Secondary end point(s): - American Colleage of Rheumatology (ACR ) 20/50/70 response rate<br> <br> - Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP) remission score (<2.6) incidence rate<br> <br> - Change from baseline in Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP) score<br>