An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
Public ClinicalTrials.gov record NCT01764997. 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, 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01764997
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 776 participants
Conditions and interventions
Conditions
Interventions
- Sarilumab Drug
- Etanercept Drug
- Methotrexate Drug
- Placebo (for sarilumab) Drug
- Placebo (for etanercept) Drug
- 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
- Mar 31, 2013
- Primary completion
- Dec 31, 2014
- Completion
- Dec 31, 2014
- Last update posted
- Jul 26, 2017
2013 – 2015
United States locations
- U.S. sites
- 30
- U.S. states
- 20
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840004 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 840212 | Glendale | California | 91205 | — |
| Investigational Site Number 840211 | Thousand Oaks | California | 91360 | — |
| Investigational Site Number 840049 | Upland | California | 91786 | — |
| Investigational Site Number 840205 | Victorville | California | 92395 | — |
| Investigational Site Number 840201 | Denver | Colorado | 80230 | — |
| Investigational Site Number 840209 | Danbury | Connecticut | 06810 | — |
| Investigational Site Number 840203 | Washington D.C. | District of Columbia | 20003 | — |
| Investigational Site Number 840210 | Clearwater | Florida | 33756 | — |
| Investigational Site Number 840128 | Ormond Beach | Florida | 32174 | — |
| Investigational Site Number 840063 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840060 | Sarasota | Florida | 34239 | — |
| Investigational Site Number 840207 | Tampa | Florida | 33612 | — |
| Investigational Site Number 840018 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840213 | Indianapolis | Indiana | 46250 | — |
| Investigational Site Number 840109 | Lake Charles | Louisiana | 70601 | — |
| Investigational Site Number 840073 | Cumberland | Maryland | 21502 | — |
| Investigational Site Number 840202 | Hagerstown | Maryland | 21740 | — |
| Investigational Site Number 840204 | Battle Creek | Michigan | 49015 | — |
| Investigational Site Number 840150 | Lansing | Michigan | 48910 | — |
| Investigational Site Number 840200 | Jackson | Mississippi | 39216 | — |
| Investigational Site Number 840037 | Tupelo | Mississippi | 38801 | — |
| Investigational Site Number 840112 | Lincoln | Nebraska | 68516 | — |
| Investigational Site Number 840056 | New York | New York | 10016 | — |
| Investigational Site Number 840117 | Pittsburgh | Pennsylvania | 15261 | — |
| Investigational Site Number 840016 | North Charleston | South Carolina | 29406 | — |
| Investigational Site Number 840025 | Jackson | Tennessee | 38305 | — |
| Investigational Site Number 840074 | Mesquite | Texas | 75150 | — |
| Investigational Site Number 840061 | Tacoma | Washington | 98405 | — |
| Investigational Site Number 840124 | Clarksburg | West Virginia | 26301 | — |
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 227 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01764997, 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 Jul 26, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01764997 live on ClinicalTrials.gov.