Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
1750
Trial Sponsor
Clinical Trial Start Date
2010
0Primary Completion Date
2011
0Study Completion Date
2011
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Other0
Drug0
Interventional Trial Phase
Phase 20
Official Name
Randomized Treatment Interruption of Natalizumab0
Last Updated
September 19, 2013
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Outcomes Assessor0
Investigator0
Care Provider0
Participant0
Other attributes
Intervention Treatment
glatiramer acetate0
IV placebo0
natalizumab0
methylprednisolone0
interferon beta 1-a0
Study 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
No Timeline data yet.
Further Resources
No Further Resources data yet.