An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate (RA-COMPARE)
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| ClinicalTrials.gov Identifier: NCT01764997 |
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Recruitment Status :
Terminated
(Due to small number of participants entering randomization. Not a safety issue.)
First Posted : January 10, 2013
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Drug: Sarilumab Drug: Etanercept Drug: Methotrexate Drug: Placebo (for sarilumab) Drug: Placebo (for etanercept) Drug: Adalimumab | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 776 participants |
| 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 |
| Study Start Date : | April 2013 |
| Actual Primary Completion Date : | January 2015 |
| Actual Study Completion Date : | January 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Rheumatoid arthritis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Adalimumab Open Label run-in
Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.
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Drug: Methotrexate
Dispensed according to local practice. Drug: Adalimumab Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous |
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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.
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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) |
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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.
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Drug: Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Other Names:
Drug: Methotrexate Dispensed according to local practice. Drug: Placebo (for etanercept) |
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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.
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Drug: Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Other Names:
Drug: Methotrexate Dispensed according to local practice. Drug: Placebo (for etanercept) |
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Experimental: Sarilumab 150 mg + MTX Open Label Sub-study
Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.
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Drug: Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Other Names:
Drug: Methotrexate Dispensed according to local practice. |
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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
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
Locations
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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01764997 |
| Other Study ID Numbers: |
EFC11574 2012-001984-66 U1111-1131-6653 ( Other Identifier: UTN ) |
| First Posted: | January 10, 2013 Key Record Dates |
| Results First Posted: | July 27, 2017 |
| Last Update Posted: | July 27, 2017 |
| Last Verified: | June 2017 |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Adalimumab Etanercept Methotrexate 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 |