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NCT01071083 · ClinicalTrials.gov registry record · Phase 2
Treatment Interruption of Natalizumab
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
NCT01071083: Completed Phase 2 study, sponsored by Biogen.
NCT01071083 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 175 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01071083, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
Study Summary
This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab. The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks: * when MS symptoms return, and * if other drugs for MS may help control MS symptoms during the natalizumab-interruption period. This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.
Primary Outcome
Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of \>0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increa
Interventions
- DRUG methylprednisolone
- DRUG natalizumab
- OTHER IV placebo
- DRUG glatiramer acetate
- DRUG interferon beta 1-a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT01071083 record still lists
NCT01071083 is an interventional study that assigns participants to a tested intervention. The registered 175 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 (32% higher).
The record links to 0 conditions, and to 5 interventions - of which methylprednisolone is the first listed.
NCT01071083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01071083 about?
NCT01071083 is a clinical study titled "Treatment Interruption of Natalizumab". This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab. The main purpose of this study is to find out the following, when participants stop taking natalizu...
What is the current status of trial NCT01071083?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2010-03. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01071083?
The interventions under investigation include: methylprednisolone (DRUG), natalizumab (DRUG), IV placebo (OTHER), glatiramer acetate (DRUG), interferon beta 1-a (DRUG).
Who is sponsoring clinical trial NCT01071083?
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 NCT01071083's enrollment target sits among peer trials
175 396th of 2000 higher than 1,605 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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