ong term evaluation of SAR153191 (REGN88) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients
- Conditions
- MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2010-019262-86-IT
- Lead Sponsor
- SANOFI-AVENTIS S.P.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1696
Patient with Rheumatoid Arthritis (RA) who was previously randomized in the EFC11072 study (MOBILITY): - Randomized in Part A (dose selection part) and who have completed the12-week treatment period, - Or randomized in Part B (confirmatory part) and who have completed the 52-week treatment period - Or randomized in Part B prior to dose selection then discontinued because non-selected dose regimen. Or Patient with Rheumatoid Arthritis (RA) who was previously randomized in the ACT11575 study and who have completed the 12-week treatment period.
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 1455
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 241
Adverse event(s) having lead to treatment discontinuation in the previous study (EFC11072 or ACT11575). Event or laboratory abnormality observed at the last treatment visit of the previous study (EFC11072 or ACT11575) that would adversely affect participation of the patient in this study as per investigator judgment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the long term safety of SAR153191 on top of Disease Modifying Anti-Rheumatic Drugs (DMARDs) in patients with rheumatoid arthritis;Secondary Objective: Assess the long term efficacy of SAR153191 on top of DMARDs in patients with rheumatoid arthritis;Primary end point(s): Number of patients with adverse events;Timepoint(s) of evaluation of this end point: Up to a maximum of 266 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Percentage of patients who achieve 20% improvement response according to the American College of Rheumatology criteria (ACR20) - Disease Activity Score (DAS28) - European League Against Rheumatism (EULAR) response;Timepoint(s) of evaluation of this end point: up to a maximum of 260 weeks