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NCT01693653 · ClinicalTrials.gov registry record · Phase 2
Tocilizumab for the Treatment of Behcet's Syndrome
A Phase 2 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT01693653: Clinical Trial Phase 2 study, sponsored by NYU Langone Health.
NCT01693653 is a Phase 2 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01693653, a Phase 2 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a double-blind placebo controlled study targeting individuals with active Behcet's Syndrome who have oral ulcers and are resistant (have not responded after 4 weeks) to conventional treatments. Maximum allowable dose of colchicine (0.6mg twice a day) and stable dose for 4 weeks before enrollment. Prednisone or equivalent (\< 10mg/day) permitted if dose stable for 6 weeks prior to enrollment. The study will investigate the safety of tocilizumab for this vasculitic condition in addition to its efficacy. The planned sample size is 30 participants per arm for a total of 60 participants. The study would be for 3 months, with a safety follow up at 2 months after study termination. Study participants will stay on their current treatments and either tocilizumab or placebo infusions will be given every 4 weeks in addition. Patients will be randomized to Actemra IV 8mg/kg Q 4 weeks X 3 doses or placebo.
Primary Outcome
The study was terminated. No data were collected for this Outcome Measure.
Interventions
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
Why NCT01693653 stopped before completion
NCT01693653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Tocilizumab is the first listed.
NCT01693653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01693653 about?
NCT01693653 is a clinical study titled "Tocilizumab for the Treatment of Behcet's Syndrome". This is a double-blind placebo controlled study targeting individuals with active Behcet's Syndrome who have oral ulcers and are resistant (have not responded after 4 weeks) to conventional treatments. Maximum allowable dose of colchicine (0.6mg twice a day) and stable dose for 4 weeks before enroll...
What is the current status of trial NCT01693653?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2012-09. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01693653?
The interventions under investigation include: Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT01693653?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01693653's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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