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NCT01217814 · ClinicalTrials.gov registry record · Phase 2
Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01217814: Clinical Trial Phase 2 study, sponsored by Sanofi.
NCT01217814 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01217814, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
Primary Objective: \- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists. Secondary Objectives: * To assess the safety of sarilumab; * To document the pharmacokinetic profile of sarilumab.
Interventions
- DRUG Placebo
- DRUG Sarilumab
- DRUG Golimumab
- DRUG methotrexate (MTX)
- DRUG Folic/folinic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
Why NCT01217814 stopped before completion
NCT01217814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01217814 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01217814 about?
NCT01217814 is a clinical study titled "Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers". Primary Objective: \- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antago...
What is the current status of trial NCT01217814?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2010-11. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01217814?
The interventions under investigation include: Placebo (DRUG), Sarilumab (DRUG), Golimumab (DRUG), methotrexate (MTX) (DRUG), Folic/folinic acid (DRUG).
Who is sponsoring clinical trial NCT01217814?
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 NCT01217814's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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