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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01146652
First received: June 15, 2010
Last updated: September 9, 2014
Last verified: September 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Uncontrolled Extension Study Evaluating the Safety and Efficacy of Sarilumab 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: Up to a maximum of 267 weeks ] [ 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 a maximum of 267 weeks ] [ Designated as safety issue: No ]
  • Disease Activity Score (DAS28) [ Time Frame: Up to a maximum of 267 weeks ] [ Designated as safety issue: No ]
  • European League Against Rheumatism (EULAR) response [ Time Frame: Up to a maximum of 267 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 2100
Study Start Date: June 2010
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 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 is expected to be approximately 267 weeks:

  • Up to 1 week of screening, if any
  • Up to 260 weeks open label treatment phase
  • 6 weeks post-treatment follow-up
  Eligibility

Ages Eligible for Study:   18 Years and older
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 314 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences and Operations Sanofi
  More Information

No publications provided

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: September 9, 2014
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 September 22, 2014