Treatment Interruption of Natalizumab (RESTORE)
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.
|Relapsing Remitting Multiple Sclerosis||Drug: natalizumab Drug: interferon beta 1-a Drug: methylprednisolone Other: IV placebo Drug: glatiramer acetate||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Treatment Interruption of Natalizumab|
- 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. [ Time Frame: 28 Weeks ]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 increase of >0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was >5.5
- Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria. [ Time Frame: 28 Weeks ]MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader.
|Study Start Date:||March 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: natalizumab||
300 mg intravenous every 4 weeks
|Placebo Comparator: IV placebo||
Other: IV placebo
placebo intravenous every 4 weeks
|Active Comparator: interferon β-1a, glatiramer acetate, or methylprednisolone||
Drug: interferon beta 1-a
30 ug intramuscular once per weekDrug: methylprednisolone
1000 mg intravenous every 4 weeksDrug: glatiramer acetate
20 mg subcutaneous once daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071083
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