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An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate (RA-COMPARE)

This study has been terminated.
(Due to small number of participants entering randomization. Not a safety issue.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764997
First Posted: January 10, 2013
Last Update Posted: July 27, 2017
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.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
  Purpose

Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.

To assess the quality of life of participants with RA taking sarilumab in combination with MTX.

To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.


Condition Intervention Phase
Rheumatoid Arthritis Drug: Sarilumab Drug: Etanercept Drug: Methotrexate Drug: Placebo (for sarilumab) Drug: Placebo (for etanercept) Drug: Adalimumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures:
  • Number of Participants With at Least 20% Improvement in American College of Rheumatology (ACR20), at Least 50% Improvement in ACR (ACR50) and at Least 70% Improvement in ACR (ACR70) Efficacy Response Rates at Week 12 and Week 24 [ Time Frame: Week 12 and Week 24 ]
  • Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24 [ Time Frame: Week 12 and Week 24 ]
  • Change From Baseline in DAS28-CRP Score at Week 12 [ Time Frame: Baseline, Week 12 ]

Enrollment: 776
Study Start Date: April 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab Open Label run-in
Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.
Drug: Methotrexate
Dispensed according to local practice.
Drug: Adalimumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Active Comparator: Etanercept + MTX (Randomized)
Etanercept 50 mg in combination with Placebo for sarilumab Q2W and etanercept 50 mg on alternating weeks for 24 weeks added to stable dose of MTX.
Drug: Etanercept
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Other Name: Enbrel
Drug: Methotrexate
Dispensed according to local practice.
Drug: Placebo (for sarilumab)
Experimental: Sarilumab 150 mg + MTX (Randomized)
Sarilumab 150 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
Drug: Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Dispensed according to local practice.
Drug: Placebo (for etanercept)
Experimental: Sarilumab 200 mg + MTX (Randomized)
Sarilumab 200 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
Drug: Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Dispensed according to local practice.
Drug: Placebo (for etanercept)
Experimental: Sarilumab 150 mg + MTX Open Label Sub-study
Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.
Drug: Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Other Names:
  • SAR153191
  • REGN88
Drug: Methotrexate
Dispensed according to local practice.

Detailed Description:

The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the randomized phase of main study was 54 weeks:

  • open label screening period of up to 4 weeks
  • open-label treatment period of 16 weeks
  • randomized screening period of 2 to 4 weeks
  • randomized treatment post-treatment safety follow-up period of 6 weeks.

The maximum study duration per participant enrolled only in the open label run-in phase and was not eligible to enroll in the randomized phase of main study was 26 weeks:

  • open label screening period of up to 4 weeks
  • open-label treatment period of 16 weeks
  • open label treatment post-treatment safety follow-up period of 6 weeks.

The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the sarilumab sub-study was 82 weeks:

  • open label screening period of up to 4 weeks
  • open-label treatment period of 16 weeks
  • screening period of 2 to 4 weeks
  • sarilumab treatment period of 52 weeks
  • sub-study post-treatment safety follow-up period of 6 weeks.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion criteria:

  • Diagnosis of RA >/= 3 months duration.
  • Continuous treatment of MTX 10 - 25 mg/week (or per local labeling requirements if the dose range differs) for at least 12 weeks before screening visit and on a stable dose for 8 weeks before screening visit.
  • Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high sensitivity C-reactive protein > 10 mg/L.

Exclusion criteria:

  • Age < 18 years.
  • Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks of the screening visit.
  • Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks of the screening visit.
  • Prior treatment with a tumor necrosis factor (TNF)-alpha inhibitor, or other biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.
  • New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors within 4 weeks of the screening visit.
  • Treatment with traditional oral DMARD /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD.

The above information is not intended to contain all considerations relevant to a participant'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): NCT01764997


  Show 257 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01764997     History of Changes
Other Study ID Numbers: EFC11574
2012-001984-66
U1111-1131-6653 ( Other Identifier: UTN )
First Submitted: January 8, 2013
First Posted: January 10, 2013
Results First Submitted: May 23, 2017
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Etanercept
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics