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 May 2013 by Sanofi
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01764997
First received: January 8, 2013
Last updated: May 15, 2013
Last verified: May 2013
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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 |
Locations
| United States, Maryland | |
| Investigational Site Number 840073 | Recruiting |
| Cumberland, Maryland, United States, 21502 | |
| United States, Tennessee | |
| Investigational Site Number 840025 | Recruiting |
| Jackson, Tennessee, United States, 38305 | |
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: | May 15, 2013 |
| 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 May 19, 2013