Nervous System Diseases: Multiple sclerosis (MS) Nervous System Diseases Multiple sclerosis (MS)
Conditions
Interventions
Does sequential treatment with Mitoxantrone and Glatiramer Acetate (Copaxone) vs. Interferon Beta in early active relapsing remitting Multiple Sclerosis lead to better patient outcomes (in terms
Sponsors
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multiple Sclerosis Impact Scale (MSIS) and Expanded Disability Status Scale (EDSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed