ong term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 16.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-019262-86-NO
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-08
• Study Completion: 2020-12-31
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2023

Inclusion Criteria

Patient with Rheumatoid Arthritis (RA) who was previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, or SFY13370 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 1536
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 404

Exclusion Criteria

Patient with any adverse event leading to permanent study drug discontinuation from a prior study.
Treatment with any concurrent biologic agents including investigational drugs for the treatment of Rheumatoid Arthritis (RA)
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 added to Disease Modifying Anti-Rheumatic Drugs (DMARDs) in patients with rheumatoid arthritis;Secondary Objective: Assess the long term efficacy of sarilumb added to 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)<br>- Disease Activity Score (DAS28)<br>- European League Against Rheumatism (EULAR) response;Timepoint(s) of evaluation of this end point: up to a maximum of 260 weeks