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NCT01764997 · ClinicalTrials.gov registry record · Phase 3
An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 776
- Enrollment target
NCT01764997: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT01764997 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 776 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01764997, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 776 participants
- Enrollment target
Study 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.
Interventions
- DRUG Methotrexate
- DRUG Sarilumab
- DRUG Etanercept
- DRUG Placebo (for sarilumab)
- DRUG Placebo (for etanercept)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 776 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
Why NCT01764997 stopped before completion
NCT01764997 is an interventional study that assigns participants to a tested intervention. The registered 776 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Methotrexate is the first listed.
NCT01764997 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01764997 about?
NCT01764997 is a clinical study titled "An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate". 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 Obj...
What is the current status of trial NCT01764997?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 776 participants. The study started on 2013-04. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01764997?
The interventions under investigation include: Methotrexate (DRUG), Sarilumab (DRUG), Etanercept (DRUG), Placebo (for sarilumab) (DRUG), Placebo (for etanercept) (DRUG).
Who is sponsoring clinical trial NCT01764997?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01764997's enrollment target sits among peer trials
776 439th of 2000 higher than 1,562 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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