Long term evaluation of sarilumab in rheumatoid arthritis patients

• Register: EUCTR
• Last refreshed on: 30 March 2021
• Main ID: EUCTR2010-019262-86-BE
• Date of registration: 04/03/2014
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis Recherche & Développement
• Public title: Long term evaluation of sarilumab in rheumatoid arthritis patients
• Scientific title: A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND
• Date of first enrolment: 20/06/2014
• Target sample size: 2000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019262-86
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Brigitte De Witte
• Affiliation: Sanofi Belgium

• Name: Brigitte De Witte
• Affiliation: Sanofi Belgium

Key inclusion & exclusion 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 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Rheumatoid Arthritis
MedDRA version: 18.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

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 unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 175-

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 unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 131.6-

Primary Outcome(s)

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

Main Objective: Assess the long term safety of sarilumab in patients with rheumatoid arthritis

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1- Up to 264 weeks
2-3- At least 264 weeks or until commercial availability whichever later but no later than 2020

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- European League Against Rheumatism (EULAR) response

Secondary ID(s)

2010-019262-86-ES

LTS11210

Source(s) of Monetary Support

sanofi-aventis Recherche & Développement

Ethics review

Status: Approved
Approval date: 20/06/2014
Contact: