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NCT02332590 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)
A Phase 3 study of Rheumatoid Arthritis, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 369
- Enrollment target
- 20
- Study locations
NCT02332590 is a Phase 3 study of Rheumatoid Arthritis that has completed, run by Sanofi. The registered enrollment target is 369 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT02332590, a Phase 3 study of Rheumatoid Arthritis, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 369 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy with respect to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte sedimentation rate (ESR) in participants with active rheumatoid arthritis (RA) who were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continued treatment with MTX, were determined to be inadequate responders. Secondary Objectives: To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy in participants with active RA who were either intolerant of, or considered inappropriate candidates for continued treatment with MTX, or after at least 12 weeks of continued treatment with MTX, were determined to be inadequate responders, with respect to: * Reduction of signs and symptoms of RA. * Improvement in quality of life assessed by participant reported outcome questionnaires. Assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity) throughout the study.
Conditions Studied
Interventions
- DRUG Adalimumab
- DRUG Sarilumab
- DRUG Placebo (for sarilumab)
- DRUG Placebo (for adalimumab)
Study Locations (20)
Florida
- Investigational Site Number 840229 - Coral Gables
- Investigational Site Number 840128 - Ormond Beach
- Investigational Site Number 840403 - St. Petersburg
- Investigational Site Number 840140 - Tampa
California
- Investigational Site Number 840407 - Covina
- Investigational Site Number 840400 - Long Beach
- Investigational Site Number 840141 - Whittier
Other
- Investigational Site Number 152005 - Osorno
- Investigational Site Number 152001 - Puerto Varas
- Investigational Site Number 152002 - Santiago
Maryland
- Investigational Site Number 840073 - Cumberland
- Investigational Site Number 840202 - Hagerstown
North Carolina
- Investigational Site Number 840402 - Charlotte
- Investigational Site Number 840406 - Hickory
Delaware
- Investigational Site Number 840130 - Lewes
Michigan
- Investigational Site Number 840232 - Flint
Nebraska
- Investigational Site Number 840112 - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2015-01-28 |
| Est. Completion | 2020-12-29 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02332590
The ClinicalTrials.gov registry entry for NCT02332590 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 369 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (92% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions - of which Adalimumab is the first listed.
NCT02332590 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Other.
Frequently Asked Questions
What is clinical trial NCT02332590 about?
NCT02332590 is a clinical study titled "Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)". Primary Objective: To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy with respect to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte sedimentation rate (ESR) in participants with active rheumatoid arthritis (RA) who were either intolera...
What is the current status of trial NCT02332590?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 369 participants. The study started on 2015-01-28. Estimated completion is 2020-12-29.
What conditions does trial NCT02332590 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT02332590?
The interventions under investigation include: Adalimumab (DRUG), Sarilumab (DRUG), Placebo (for sarilumab) (DRUG), Placebo (for adalimumab) (DRUG).
Who is sponsoring clinical trial NCT02332590?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02332590 being conducted?
This trial has 20 study locations across California, Delaware, Florida, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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