Natalizumab Temporary Discontinuation Study

Launched by UNIVERSITY AT BUFFALO · May 13, 2016

Keywords

ClinConnect Summary

Natalizumab is a pharmaceutical intervention used in the management of multiple sclerosis.

The decision to discontinue natalizumab therapy is often raised in patients defined as high-risk for PML despite good clinical efficacy. During the therapy cessation period following large phase III trials, a return to the prestudy disease activity was reached by four months post-discontinuation. Shorter therapy was associated with a trend for a more severe disease activity pointing to a possible 'rebound' effect after natalizumab discontinuation.

This study focuses on two different approaches: an i...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient with relapsing-remitting or relapsing-progressive (relapsing-remitting with incomplete recovery and secondary progressive with superimposed relapses) MS according to the McDonald criteria who have been on natalizumab therapy for at least 12 months
• • Age 18-65
• • Have EDSS scores less than or equal to 7.0
• • Positive John Cunningham (JC) virus antibody results at screening
• • Signed informed consent
• • None of the exclusion criteria
• Exclusion Criteria:
• • Patients not willing or able to personally provide informed consent (subjects with cognitive impairment that effects the ability to provide informed consent for participation)
• • Patients with active disease per clinical and MRI evaluation at baseline
• • Patients with renal disease that precludes having an MRI with gadolinium contrast