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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 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 123 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00616434
The ClinicalTrials.gov registry entry for NCT00616434 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00616434 reports 0 study locations.
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.
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