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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 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 16 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01217814
The ClinicalTrials.gov registry entry for NCT01217814 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01217814 reports 0 study locations.
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.
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