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Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01146652
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : January 26, 2021
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE June 15, 2010
First Posted Date  ICMJE June 17, 2010
Last Update Posted Date January 26, 2021
Actual Study Start Date  ICMJE June 14, 2010
Actual Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Number of patients with adverse events [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
Number of patients with adverse events [ Time Frame: 266 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • Percentage of patients who achieve 20% improvement response according to the American College of Rheumatology criteria (ACR20) [ Time Frame: Up to 264 weeks ]
  • Disease Activity Score (DAS28-CRP) [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ]
  • European League Against Rheumatism (EULAR) response [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
  • Achievement of 20% response according to the American College of Rheumatology criteria for improvement (ACR20) [ Time Frame: up to a maximum of 260 weeks ]
  • Disease Activity Score (DAS28) [ Time Frame: up to a maximum of 260 weeks ]
  • European League Against Rheumatism (EULAR) response [ Time Frame: up to a maximum of 260 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
Official Title  ICMJE A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)
Brief Summary

Primary 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.

Detailed Description

The maximum duration of the study may be up to 523 weeks:

  • Up to 1-week of screening, if any
  • At least 264 weeks of open label treatment phase and up to 516 weeks as maximum
  • 6-week post-treatment follow-up as required per protocol.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous

Study Arms  ICMJE Experimental: Extension study
Sarilumab (SAR153191), Disease Modifying Anti-Rheumatic Drug (DMARD) therapy as required in the initial protocol.
Intervention: Drug: SAR153191 (REGN88)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2020)
2025
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2010)
1500
Actual Study Completion Date  ICMJE December 30, 2020
Actual Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

Patients with Rheumatoid Arthritis (RA) who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, or EFC13752 study.

Exclusion criteria:

Patients 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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czechia,   Ecuador,   Estonia,   Finland,   Germany,   Greece,   Guatemala,   Hungary,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01146652
Other Study ID Numbers  ICMJE LTS11210
2010-019262-86 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Study Director: Clinical Sciences and Operations Sanofi
PRS Account Sanofi
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP