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NCT01061723 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 301
- Enrollment target
NCT01061723: Completed Phase 2 study, sponsored by Sanofi.
NCT01061723 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 301 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01061723, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 301 participants
- Enrollment target
Study Summary
Primary objective: \- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: * to demonstrate that Sarilumab was effective on: * assessment of higher level of response \[ASAS 40% response criteria (ASAS40)\] * partial remission * disease activity * range of motion * Magnetic Resonance Imaging (MRI) of the spine * to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS
Primary Outcome
Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index \[BASFI\]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (m
Interventions
- DRUG Placebo
- DRUG Sarilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT01061723 record still lists
NCT01061723 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01061723 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01061723 about?
NCT01061723 is a clinical study titled "Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis". Primary objective: \- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: * to demonstrate that Sarilumab was effective on: * assessment of higher le...
What is the current status of trial NCT01061723?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 301 participants. The study started on 2010-02. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01061723?
The interventions under investigation include: Placebo (DRUG), Sarilumab (DRUG).
Who is sponsoring clinical trial NCT01061723?
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 NCT01061723's enrollment target sits among peer trials
301 167th of 2000 higher than 1,834 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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