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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: Completed Phase 2 study, sponsored by Sanofi.
NCT01061736 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 1,675 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1159% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Ca
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 |
What the finished NCT01061736 record still lists
NCT01061736 is an interventional study that assigns participants to a tested intervention. Its 1,675 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1159% higher).
The record links to 0 conditions, and to 4 interventions - of which Methotrexate is the first listed.
NCT01061736 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01061736's enrollment target sits among peer trials
1,675 11th of 2000 higher than 1,990 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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