ong term evaluation of sarilumab in rheumatoid arthritis patients

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 21.0Level: 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-LT
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-26
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

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, 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