Status:
TERMINATED
Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 (R...
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. P...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of rheumatoid arthritis ≥6 months duration and American College of Rheumatology (ACR) Class I-III functional status at screening and baseline visits;
- Active disease defined as:
- At least 6 of 68 tender joints and 6 of 66 swollen joints at screening and baseline visits, and
- hs-C-Reactive Protein (hs-CRP) \>10 g/L or Erythrocyte Sedimentation Rate (ESR) \>28 mm/hr at screening visit;
- Continuous treatment with Methotrexate for at least 12 weeks and on stable dose (minimum 10 mg/week) for at least 6 weeks prior to the screening visit;
- Participant considered as Primary TNF-α blocker nonresponder. i.e.:
- Appropriate for previous TNF-α blocker therapy
- Lack of adequate clinical response after at least 3 months TNF-α blocker therapy with MTX or other synthetic disease modifying anti-rheumatic drug (DMARD) co-therapy.
- Exclusion criteria:
- Age \<18 years or \>75 years;
- Pregnant or breastfeeding woman or woman of childbearing potential, unwilling to utilize adequate contraception or not to become pregnant during the entire study;
- Fever (\>38°C), or chronic, persistent, or recurring infection(s);
- History of demyelinating disease;
- Current underlying hepatobiliary disease.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01217814
Start Date
November 1 2010
End Date
September 1 2011
Last Update
September 1 2017
Active Locations (14)
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1
Investigational Site Number 840026
Freehold, New Jersey, United States, 07728
2
Investigational Site Number 840043
New York, New York, United States, 11201
3
Investigational Site Number 840025
Jackson, Tennessee, United States, 38305
4
Investigational Site Number 840038
Austin, Texas, United States, 78705