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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 : Active, not recruiting
First Posted : June 17, 2010
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: SAR153191 (REGN88) Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : June 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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



Outcome Measures

Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( EudraCT Number )
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017

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