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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: Completed Phase 3 study of Rheumatoid Arthritis, sponsored by Sanofi.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR and RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3
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 |
What the finished NCT02332590 record still lists
NCT02332590 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (92% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
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Where NCT02332590's enrollment target sits among peer trials
369 50th of 197 higher than 148 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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