Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)
Public ClinicalTrials.gov record NCT02332590. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02332590
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 369 participants
Conditions and interventions
Conditions
Interventions
- Sarilumab Drug
- Adalimumab Drug
- Placebo (for sarilumab) Drug
- Placebo (for adalimumab) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 27, 2015
- Primary completion
- Jan 19, 2016
- Completion
- Dec 28, 2020
- Last update posted
- Mar 27, 2022
2015 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 10
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840407 | Covina | California | 91723 | — |
| Investigational Site Number 840400 | Long Beach | California | 90808 | — |
| Investigational Site Number 840141 | Whittier | California | 90606 | — |
| Investigational Site Number 840130 | Lewes | Delaware | 19958 | — |
| Investigational Site Number 840229 | Coral Gables | Florida | 33134 | — |
| Investigational Site Number 840128 | Ormond Beach | Florida | 32174 | — |
| Investigational Site Number 840403 | St. Petersburg | Florida | 33708 | — |
| Investigational Site Number 840140 | Tampa | Florida | 33614 | — |
| Investigational Site Number 840073 | Cumberland | Maryland | 21502 | — |
| Investigational Site Number 840202 | Hagerstown | Maryland | 21740 | — |
| Investigational Site Number 840232 | Flint | Michigan | 48504 | — |
| Investigational Site Number 840112 | Lincoln | Nebraska | 68516 | — |
| Investigational Site Number 840402 | Charlotte | North Carolina | 28210 | — |
| Investigational Site Number 840406 | Hickory | North Carolina | 28601 | — |
| Investigational Site Number 840404 | Middleburg Heights | Ohio | 44130 | — |
| Investigational Site Number 840127 | Oklahoma City | Oklahoma | 73103 | — |
| Investigational Site Number 840074 | Mesquite | Texas | 75150 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02332590, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 27, 2022 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02332590 live on ClinicalTrials.gov.