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NCT01864148 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 419
- Enrollment target
NCT01864148: Completed Phase 2 study, sponsored by Biogen.
NCT01864148 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 419 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (215% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01864148, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 419 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex. Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
Primary Outcome
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of \<=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement
Interventions
- OTHER Placebo
- DRUG Avonex
- DRUG BIIB033
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 419 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT01864148 record still lists
NCT01864148 is an interventional study that assigns participants to a tested intervention. The registered 419 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (215% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01864148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01864148 about?
NCT01864148 is a clinical study titled "Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex". The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex. Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokine...
What is the current status of trial NCT01864148?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 419 participants. The study started on 2013-08. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01864148?
The interventions under investigation include: Placebo (OTHER), Avonex (DRUG), BIIB033 (DRUG).
Who is sponsoring clinical trial NCT01864148?
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 NCT01864148's enrollment target sits among peer trials
419 91st of 2000 higher than 1,910 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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