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

This study is currently recruiting participants.
Verified April 2014 by Sanofi
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01764997
First received: January 8, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

Primary Objective:

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

Secondary Objectives:

To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab in combination with methotrexate (MTX).

To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in combination with methotrexate (MTX).

To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP score) score change from baseline (randomized treatment phase) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with American College of Rheumatology (ACR) efficacy response rates of 20%, 50% and 70% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP) remission score (<2.6) incidence rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP) score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: April 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Main Study, Sarilumab, Dose 1 or Dose 2
Sarilumab, Dose 1 or Dose 2, every other week in combination with methotrexate
Drug: Sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous
Active Comparator: Main study, Etanercept, Dose 1
Etanercept, Dose 1 every week in combination with methotrexate
Drug: Etanercept
Pharmaceutical form:solution Route of administration: subcutaneous
Main Study, Adalimumab, Dose 1
Adalimumab, Dose 1 every week in combination with methotrexate
Drug: Adalimumab
Pharmaceutical form:solution Route of administration: subcutaneous

Detailed Description:

The maximum study duration per patient enrolled in the Main study is 54 weeks broken down as follows:

  • screening/run-in up to a maximum of 24 weeks
  • treatment up to a maximum of 24 weeks
  • follow-up of 6 weeks after treatment discontinuation.

The maximum study duration per patient enrolled in the Sub-study is 58 weeks broken down as follows:

  • treatment up to a maximum of 52 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:

  • Diagnosis of rheumatoid arthritis (RA) >/= 3 months duration.
  • Continuous treatment of methotrexate (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 TNF (tumor necrosis factor)-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 inhibitors (COX-2 inhibitors within 4 weeks of the screening visit.
  • Treatment with traditional oral disease-modifying antirheumatic drugs (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 patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764997

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 215 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01764997     History of Changes
Other Study ID Numbers: EFC11574, 2012-001984-66, U1111-1131-6653
Study First Received: January 8, 2013
Last Updated: April 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
Methotrexate
TNFR-Fc fusion protein
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
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, Non-Steroidal
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on April 23, 2014