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NCT00906399 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
A Phase 3 study of Relapsing Multiple Sclerosis, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,516
- Enrollment target
- 20
- Study locations
NCT00906399: Completed Phase 3 study of Relapsing Multiple Sclerosis, sponsored by Biogen.
NCT00906399 is a Phase 3 study of Relapsing Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 1,516 participants, below the 2,103-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00906399, a Phase 3 study of Relapsing Multiple Sclerosis, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,516 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.
Primary Outcome
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Sc
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BIIB017 (peginterferon beta-1a)
Study Locations (20)
Other
- Research Site - Brussels
- Research Site - Sint-Truiden
- Research Site - Plovdiv
- Research Site - Sofia
- Research Site - Sofia
- Research Site - Sofia
- Research Site - Sofia
- Research Site - Sofia
Ohio
- Research Site - Akron
- Research Site - Cleveland
Arizona
- Research Site - Phoenix
Florida
- Research Site - Ponte Vedra Beach
Georgia
- Research Site - Atlanta
Iowa
- Research Site - Des Moines
Kentucky
- Research Site - Lexington
Maryland
- Research Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,516 participants |
| Start Date | 2009-06 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT00906399 record still lists
NCT00906399 is an interventional study that assigns participants to a tested intervention. Its 1,516 participants enrollment target places it among the larger protocols in the corpus, below the 2,103-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (28% lower).
The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00906399 names 20 study sites across 12 states, led by Other, Ohio, Arizona.
Frequently Asked Questions
What is clinical trial NCT00906399 about?
NCT00906399 is a clinical study titled "Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis". The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year ...
What is the current status of trial NCT00906399?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,516 participants. The study started on 2009-06. Estimated completion is 2013-10.
What conditions does trial NCT00906399 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis.
What interventions are being tested in trial NCT00906399?
The interventions under investigation include: Placebo (DRUG), BIIB017 (peginterferon beta-1a) (DRUG).
Who is sponsoring clinical trial NCT00906399?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00906399 being conducted?
This trial has 20 study locations across Arizona, Florida, Georgia, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Relapsing Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00906399's enrollment target sits among peer trials
1,516 4th of 23 higher than 20 of 23 other Relapsing Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsing Multiple Sclerosis 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.
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