Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019262-86-CZ

Enrollment

2025

Registered

2011-03-30

Start date

2013-03-26

Completion date

Unknown

Last updated

2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Sarilumab Product Code: SAR153191 (REGN88) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Sarilumab Current Sponsor code: SAR153191 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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 1735 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 290

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the long term safety of sarilumab in patients with rheumatoid arthritis;Secondary Objective: Assess the long term efficacy of sarilumab 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 no later than 2020	—

Secondary

Measure	Time frame
Secondary end point(s): 1- Percentage of patients who achieve 20% improvement according to the American College of Rheumatology criteria (ACR20) 2- Disease Activity Score (DAS28-CRP) 3- Disease Activity Score (DAS28-CRP) over time 4- European League Against Rheumatism (EULAR) response;Timepoint(s) of evaluation of this end point: 1- Up to 264 weeks 2-3-4- At least 264 weeks or until commercial availability whichever later but no later than 2020	—

Measure

Time frame

Secondary end point(s): 1- Percentage of patients who achieve 20% improvement according to the American College of Rheumatology criteria (ACR20) 2- Disease Activity Score (DAS28-CRP) 3- Disease Activity Score (DAS28-CRP) over time 4- European League Against Rheumatism (EULAR) response;Timepoint(s) of evaluation of this end point: 1- Up to 264 weeks 2-3-4- At least 264 weeks or until commercial availability whichever later but no later than 2020

—

Countries

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Ecuador, Estonia, Finland, Germany, Greece, Guatemala, Hungary, Israel, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

Public Contactwww.sanofi-aventis.cz

sanofi-aventis, s.r.o.

cz-info@sanofi.com+420233086111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026