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NCT00616434 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT00616434: Completed Phase 2 study, sponsored by Biogen.
NCT00616434 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616434, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the clinical activity of interferon beta-1a in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this study are to determine (i) the safety and tolerability of interferon beta-1a in participants with moderate to severe UC, and (ii) the percentage of participants, with a decrease in the Simple Clinical Colitis Activity Index (SCCAI) score of ≥3 points at Week 8.
Primary Outcome
Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment
Interventions
- DRUG Placebo
- DRUG BG9418 (Interferon beta-1a)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00616434 record still lists
NCT00616434 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00616434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00616434 about?
NCT00616434 is a clinical study titled "A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis". The primary objective of the study is to evaluate the clinical activity of interferon beta-1a in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this study are to determine (i) the safety and tolerability of interferon beta-1a in participants with moderate to se...
What is the current status of trial NCT00616434?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2008-05. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00616434?
The interventions under investigation include: Placebo (DRUG), BG9418 (Interferon beta-1a) (DRUG).
Who is sponsoring clinical trial NCT00616434?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00616434's enrollment target sits among peer trials
123 564th of 2000 higher than 1,436 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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