A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis

Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)0 sites0 target enrollmentSeptember 30, 2005

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Status: Completed
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

September 30, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sponsor

Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)

•1\. Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001\) with a relapsing remitting disease course.
•2\. Aged 18 to 55\.
•3\. 2 relapses in the past 2 years (this is part of the ABN guidelines to use GA and Interferon).
•4\. EDSS 0 \- 5\.5 (able to walk at least 100m without aid).
•5\. Disease duration less than 5 years from onset (if used later in the disease may not prevent progression).
•6\. At least 3 of the following: patients with three or more attacks in the first two years of disease; motor involvement in early attacks (weakness/ataxia); incomplete recovery from early attacks (EDSS \>1\.5\); 10 or more T2 weighted MRI brain lesions (these 4 items are markers of increased risk of early disability).