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NCT01441076 · ClinicalTrials.gov registry record · Phase 1
Anakinra for Behcet s Disease
A Phase 1 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01441076: Completed Phase 1 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
NCT01441076 is a Phase 1 study that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01441076, a Phase 1 study, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Background: \- Behcet's disease (BD) is an autoimmune disease where the immune system attacks the body. People with BD may develop oral or genital ulcers, skin problems, and eye disease. Most drugs used to treat BD suppress the immune system, but they are not always helpful and may have side effects. A new drug, anakinra, may be able to treat BD with fewer side effects. Because it has not been studied in people with BD, anakinra is considered an experimental treatment. Objectives: \- To test whether anakinra can be a safe and effective treatment for Behcet s disease. Eligibility: \- People who have Behcet's disease with ongoing oral or genital ulcers for at least one month, or three or more flares of eye disease in the past 6 months. Design: * Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. They will be divided into two groups: those with oral or genital ulcers and those with eye disease. * All participants will keep a diary of symptoms for a month before starting the study drug. * Participants with oral or genital ulcers will receive daily injections of anakinra for 3 to 6 months. Treatment will be monitored with frequent blood draws and daily diaries. Those who improve but do not have a full response to the drug may receive a higher dose. Those who improve after 6 months may have an extra 6 months on either anakinra or placebo to study the differences in response. * Participants with eye disease will receive anakinra for up to 12 months. Treatment will be monitored with frequent blood draws, daily diaries, and regular eye exams. * All participants will have a final study visit 1 month after stopping the study drug.
Primary Outcome
Clinical remission was defined as no oral or vaginal ulcers on physical examination for 2 consecutive monthly visits from months 3-6.
Interventions
- DRUG Anakinra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What the finished NCT01441076 record still lists
NCT01441076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Anakinra is the first listed.
NCT01441076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01441076 about?
NCT01441076 is a clinical study titled "Anakinra for Behcet s Disease". Background: \- Behcet's disease (BD) is an autoimmune disease where the immune system attacks the body. People with BD may develop oral or genital ulcers, skin problems, and eye disease. Most drugs used to treat BD suppress the immune system, but they are not always helpful and may have side effect...
What is the current status of trial NCT01441076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-09. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01441076?
The interventions under investigation include: Anakinra (DRUG).
Who is sponsoring clinical trial NCT01441076?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01441076's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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