Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 301 participants.
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
Interventions
- DRUG Placebo
- DRUG Sarilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01061723
The ClinicalTrials.gov registry entry for NCT01061723 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 301 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 2 interventions - of which Placebo is the first listed.
NCT01061723 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.