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NCT01118728 · ClinicalTrials.gov registry record · Phase 2

Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

A Phase 2 study, sponsored by Sanofi.

Terminated
Registry status
Phase 2
Development phase
223
Enrollment target

NCT01118728: Clinical Trial Phase 2 study, sponsored by Sanofi.

NCT01118728 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 223 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01118728, a Phase 2 study, was terminated before completion, sponsored by Sanofi.

TERMINATED
Registry status
Phase 2
Development phase
223 participants
Enrollment target

Study Summary

Primary Objective: * To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS) Secondary Objective: * To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS

Primary Outcome

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of the relationship to the investigational medicinal product (IMP). SAE was any untoward medical occurrence that at any dose resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or was a congenital anoma

Interventions

  • DRUG Sarilumab

Trial Details

FieldValue
Enrollment Target 223 participants
Start Date 2010-06
Est. Completion 2011-12
Phase Phase 2
Sanofi

713 total trials

Why NCT01118728 stopped before completion

NCT01118728 is an interventional study that assigns participants to a tested intervention. The registered 223 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 (68% higher).

The record links to 0 conditions, and to 1 intervention - of which Sarilumab is the first listed.

NCT01118728 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01118728 about?

NCT01118728 is a clinical study titled "Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis". Primary Objective: * To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS) Secondary Objective: * To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS

What is the current status of trial NCT01118728?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 223 participants. The study started on 2010-06. Estimated completion is 2011-12.

What interventions are being tested in trial NCT01118728?

The interventions under investigation include: Sarilumab (DRUG).

Who is sponsoring clinical trial NCT01118728?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01118728's enrollment target sits among peer trials

223 274th of 2000 higher than 1,727 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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Source: ClinicalTrials.gov NCT01118728, the US trial registry maintained by the National Library of Medicine. NCT01118728 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.