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NCT01709578 · ClinicalTrials.gov registry record · Phase 3
To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 546
- Enrollment target
NCT01709578 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 546 participants.
The verdict
NCT01709578, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 546 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for: * reduction of signs and symptoms at Week 24 and * improvement of physical function at Week 12 in participants with active rheumatoid arthritis (RA) who were inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists. Secondary Objectives: The secondary objectives were to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in participants with active RA who were inadequate responders or intolerant to TNF-α antagonists, for: * Reduction of signs and symptoms at Week 12; * Improvement in physical function at Week 24; * Improvement in disease activity score as measured by other American College of Rheumatology (ACR) derived components at Weeks 12 and 24; * Improvement in quality of life as measured by participant reported outcomes (PROs) at intermediate visits and Week 24. To assess the exposure of sarilumab added to DMARD therapy in this population. To assess the safety of sarilumab in this population.
Interventions
- DRUG placebo
- DRUG Sarilumab
- DRUG methotrexate
- DRUG hydroxychloroquine
- DRUG sulfasalazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2012-10 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01709578
The ClinicalTrials.gov registry entry for NCT01709578 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 546 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.
NCT01709578 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01709578 about?
NCT01709578 is a clinical study titled "To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)". Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for: * reduction of signs and symptoms at Week 24 and * improvement of physical function at Week 12 in participants with active rheumatoid arthritis (RA) who were inadequate re...
What is the current status of trial NCT01709578?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 546 participants. The study started on 2012-10. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01709578?
The interventions under investigation include: placebo (DRUG), Sarilumab (DRUG), methotrexate (DRUG), hydroxychloroquine (DRUG), sulfasalazine (DRUG).
Who is sponsoring clinical trial NCT01709578?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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