At a glance
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Randomized Treatment Interruption of Natalizumab
In Brief
A Phase 2 clinical trial evaluating natalizumab, interferon beta 1-a, and 3 other interventions for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 175 participants across 33 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
300 mg intravenous every 4 weeks
30 ug intramuscular once per week
1000 mg intravenous every 4 weeks
placebo intravenous every 4 weeks
20 mg subcutaneous once daily