drugset / Trial / NCT01071083

Treatment Interruption of Natalizumab

NCT01071083

Phase 2 Completed 175 enrolled Biogen Elan Pharmaceuticals · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-03
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glatiramer Acetate Small molecule 20 mg Subcutaneous
Comparator Interferon beta-1a Protein / enzyme biologic 30 ug Intramuscular
Comparator Methylprednisolone Other / unclassified 1000 mg Intravenous
Comparator natalizumab Monoclonal antibody 300 mg Intravenous