Alternative Treatment Paradigm for Natalizumab Trial
Status:
Withdrawn
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
This study is being done to determine the difference between natalizumab therapy followed by
two different withdrawal strategies using Glatiramer Acetate (GA) treatment paradigms in
preventing clinical relapses and other markers of disease activity in patients diagnosed with
Multiple Sclerosis (MS).
We hypothesize that GA plus corticosteroids versus GA alone will prevent or reduce the
re-occurrence of MS disease activity after discontinuation of natalizumab over a 12 month
period. We further hypothesize that natalizumab therapy followed by GA treatment allows the
reconstitution of the peripheral and CNS immune homeostasis.
Primary objective:
The primary endpoint will be the annualized relapse rate over the post randomization months
as well as estimates of change over the natalizumab therapy period over the entire 12 months.
Secondary objectives:
To determine if and how long it takes for restoration of immune homeostasis under GA therapy
following discontinuation of natalizumab.
Phase:
Phase 2
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborators:
Charite University, Berlin, Germany Teva Branded Pharmaceutical Products R&D, Inc. Teva Pharmaceutical Industries The University of Texas Health Science Center, Houston University of Alabama at Birmingham