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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01146652
First received: June 15, 2010
Last updated: October 5, 2015
Last verified: September 2015
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: SAR153191 (REGN88)
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of patients who achieve 20% improvement response according to the American College of Rheumatology criteria (ACR20) [ Time Frame: Up to 264 weeks ] [ Designated as safety issue: No ]
  • Disease Activity Score (DAS28-CRP) [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ] [ Designated as safety issue: No ]
  • European League Against Rheumatism (EULAR) response [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: June 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extension study
Sarilumab (SAR153191), Disease Modifying Anti-Rheumatic Drug (DMARD) therapy as required in the initial protocol.
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous


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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146652

  Show 335 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences and Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01146652     History of Changes
Other Study ID Numbers: LTS11210  2010-019262-86 
Study First Received: June 15, 2010
Last Updated: October 5, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 25, 2016