Phase 2
N=175
Treatment Interruption of Natalizumab
Relapsing Remitting Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01071083 ↗Enrolled (actual)
175
Serious AEs
—
Results posted
Jan 2013
Primary outcome: Primary: Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria. — 4.7; 60.5; 28.6; 53.3 Percentage of subjects meeting criteria
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- natalizumab (Drug); interferon beta 1-a (Drug); methylprednisolone (Drug); IV placebo (Other); glatiramer acetate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria. |
4.7; 60.5; 28.6; 53.3; 54.8 | — |
| SECONDARY Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria. |
0.0; 52.5; 8.3; 49.7; 46.1 | — |
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.
Eligibility Criteria
Major criteria include:
- A diagnosis of a relapsing form of MS
- Treatment with natalizumab according to locally approved prescribing information
- Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01071083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.