ong term evaluation of sarilumab in rheumatoid arthritis patients
Phase 1
- Conditions
- MedDRA version: 18.1Level: 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-AT
- Lead Sponsor
- sanofi-aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
Patient with Rheumatoid Arthritis (RA) who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370 study; or EFC13752 study
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 1584
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 416
Exclusion Criteria
Patient with any adverse event leading to permanent study drug discontinuation from a prior study.
Patients with an abnormality(ies) or adverse event(s) that per investigator judgment would adversely affect participation of the patient in the study
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 sarilumab in patients with<br>rheumatoid arthritis;Secondary Objective: Assess the long term efficacy of sarilumb in patients with rheumatoid arthritis;Primary end point(s): Number of patients with adverse events;Timepoint(s) of evaluation of this end point: At least 264 weeks or until commercial availability whichever later but<br>no later than 2020
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Percentage of patients who achieve 20% improvement response according to the American College of Rheumatology criteria (ACR20)<br>2- Disease Activity Score (DAS28-CRP)<br>3- European League Against Rheumatism (EULAR) response;Timepoint(s) of evaluation of this end point: 1- Up to 264 weeks<br>2-3- At least 264 weeks or until commercial availability whichever<br>later but no later than 2020