Long Term Evaluation of SAR153191 (REGN88, Sarilumab) on Top of Disease Modifying Anti-rheumatic Drugs 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: July 16, 2014
Last verified: July 2014
  Purpose

Primary Objective:

Assess the long term safety of sarilumab added to Disease Modifying Anti-Rheumatic Drugs (DMARDs) in patients with rheumatoid arthritis

Secondary Objective:

Assess the long term efficacy of sarilumab added to DMARDs 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 Safety and Efficacy of SAR153191 on Top of DMARDs 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 266 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 260 weeks ] [ Designated as safety issue: No ]
  • Disease Activity Score (DAS28) [ Time Frame: Up to a maximum of 260 weeks ] [ Designated as safety issue: No ]
  • European League Against Rheumatism (EULAR) response [ Time Frame: Up to a maximum of 260 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 study duration per patient is 267 weeks broken down as follows:

  • screening up to a maximum of 1 week
  • treatment up to a maximum of 260 weeks
  • follow-up of 6 weeks after treatment discontinuation
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

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

Exclusion criteria:

Patient with any adverse event leading to permanent study drug discontinuation from a prior study.

Treatment with any concurrent biologic agents including investigational drugs for the treatment of Rheumatoid Arthritis (RA).

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 306 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: July 16, 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
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014