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NCT01332019 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety and Efficacy Study of Peginterferon Beta-1a
A Phase 3 study of Relapsing Multiple Sclerosis, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,077
- Enrollment target
- 20
- Study locations
NCT01332019: Completed Phase 3 study of Relapsing Multiple Sclerosis, sponsored by Biogen.
NCT01332019 is a Phase 3 study of Relapsing Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 1,077 participants, below the 2,123-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01332019, a Phase 3 study of Relapsing Multiple Sclerosis, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,077 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.
Primary Outcome
AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medical
Conditions Studied
Interventions
- DRUG peginterferon beta-1a
Study Locations (20)
Other
- Research Site - Sint-Truiden
- Research Site - Plovdiv
- Research Site - Sofia
- Research Site - Sofia
- Research Site - Sofia
- Research Site - Sofia
- Research Site - Sofia
- Research Site - Santiago
- Research Site - Barranquilla
- Research Site - Bogotá
- Research Site - Zagreb
Ohio
- Research Site - Akron
- Research Site - Cleveland
Georgia
- Research Site - Atlanta
Kentucky
- Research Site - Lexington
Maryland
- Research Site - Baltimore
North Carolina
- Research Site - Raleigh
Tennessee
- Research Site - Franklin
Ontario
- Research Site - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,077 participants |
| Start Date | 2011-04 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT01332019 record still lists
NCT01332019 is an interventional study that assigns participants to a tested intervention. Its 1,077 participants enrollment target places it among the larger protocols in the corpus, below the 2,123-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which peginterferon beta-1a is the first listed.
NCT01332019 names 20 study sites across 9 states, led by Other, Ohio, Georgia.
Frequently Asked Questions
What is clinical trial NCT01332019 about?
NCT01332019 is a clinical study titled "Long-Term Safety and Efficacy Study of Peginterferon Beta-1a". The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term ...
What is the current status of trial NCT01332019?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,077 participants. The study started on 2011-04. Estimated completion is 2015-10.
What conditions does trial NCT01332019 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis.
What interventions are being tested in trial NCT01332019?
The interventions under investigation include: peginterferon beta-1a (DRUG).
Who is sponsoring clinical trial NCT01332019?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01332019 being conducted?
This trial has 20 study locations across Georgia, Kentucky, Maryland, North Carolina, Ohio. 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 NCT01332019's enrollment target sits among peer trials
1,077 5th of 23 higher than 19 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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