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Treatment Interruption of Natalizumab — RESTORE  

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:
Randomized Treatment Interruption of Natalizumab

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting
  • Relapsing Remitting Multiple Sclerosis
Clinical Trial Details
NCT number NCT01071083
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 2
Start date March 2010
Completion date November 2011
View Details
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