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NCT02241785 · ClinicalTrials.gov registry record · Phase 4
Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies
A Phase 4 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 4
- Development phase
- 47
- Enrollment target
NCT02241785: Clinical Trial Phase 4 study, sponsored by Biogen.
NCT02241785 is a Phase 4 study that was terminated before completion, run by Biogen. The registered enrollment target is 47 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02241785, a Phase 4 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 47 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine the efficacy of natalizumab (Tysabri, BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have failed Gilenya or BRACET (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera) as measured by the proportion of participants with no evidence of disease activity (NEDA) at Year 1. The secondary objectives in this study population are: change in total T1 hypointense and total T2 hyperintense lesion volume; proportion of participants with NEDA at Year 2; evaluation of the impact of natalizumab on annualized relapse rate (ARR); and change in Multiple Sclerosis Impact Scale-29 (MSIS-29) physical impact score.
Primary Outcome
The proportion of participants with NEDA, defined as follows: no Expanded Disability Status Scale (EDSS) progression (12-week sustained); no relapses; no gadolinium enhancing (Gd+) lesions; no new or enlarging T2 hyperintense lesions over 48 weeks after resetting the Baseline at Week 8 to remove contribution of combined unique active (CUA) lesions that occurred prior to Week 8, when natalizumab was not yet active. The EDSS quantifies disability in 8 functional systems. The final EDSS score is an
Interventions
- DRUG natalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2014-09-30 |
| Est. Completion | 2016-05-02 |
| Phase | Phase 4 |
Why NCT02241785 stopped before completion
NCT02241785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which natalizumab is the first listed.
NCT02241785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02241785 about?
NCT02241785 is a clinical study titled "Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies". The primary objective of the study is to determine the efficacy of natalizumab (Tysabri, BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have failed Gilenya or BRACET (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera) as measured by the proportion of participants w...
What is the current status of trial NCT02241785?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 47 participants. The study started on 2014-09-30. Estimated completion is 2016-05-02.
What interventions are being tested in trial NCT02241785?
The interventions under investigation include: natalizumab (DRUG).
Who is sponsoring clinical trial NCT02241785?
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 NCT02241785's enrollment target sits among peer trials
47 1348th of 2000 higher than 653 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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