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NCT01061736 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,675
- Enrollment target
NCT01061736 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 1,675 participants.
The verdict
NCT01061736, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,675 participants
- Enrollment target
Study Summary
Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: * reduction of signs and symptoms of rheumatoid arthritis at 24 weeks * inhibition of progression of structural damage at 52 weeks * improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.
Interventions
- DRUG Methotrexate
- DRUG Sarilumab
- DRUG Folic Acid
- DRUG Placebo (for sarilumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,675 participants |
| Start Date | 2010-03 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01061736
The ClinicalTrials.gov registry entry for NCT01061736 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,675 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 4 interventions - of which Methotrexate is the first listed.
NCT01061736 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01061736 about?
NCT01061736 is a clinical study titled "Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients". Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: * reduction ...
What is the current status of trial NCT01061736?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,675 participants. The study started on 2010-03. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01061736?
The interventions under investigation include: Methotrexate (DRUG), Sarilumab (DRUG), Folic Acid (DRUG), Placebo (for sarilumab) (DRUG).
Who is sponsoring clinical trial NCT01061736?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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