Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0259157815
Study information
Scientific title
Acronym
Study hypothesis
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 of the reduced relapses, reduced disability and improved quality of life)?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Nervous System Diseases: Multiple sclerosis (MS)
Intervention
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 of the reduced relapses, reduced disability and improved quality of life)?
The study design was chosen in order to have a 'head to head' comparison of this new combination versus the best available therapy. Consultation was held with lead neurologists in other regional centres. The reason for comparing this treatment combination to high-dose Interferon Beta (Rebif 44) is that in most UK centres interferon would be considered 'standard or best' management of active relapsing remitting multiple sclerosis. There was no consideration of using a placebo as not to treat this patient group would lead to sustained disability in the long term (and would be unethical). The risks to the patients are minimised by proper safety tests (including echocardiograms, blood and urine tests) both before and during treatment. Also, the patients will not be excessively inconvenienced as we have tailored visits to be similar to what occurs in normal NHS practice.
Timetable:
- February 2005 - January 2006: Recruitment of Patients
- January 2006 - January 2009: Follow-up of patients with ongoing data collection.
- February 2009 - June 2009: Analysis and Presentation/Publication of Data.
The interviews will take place at the Clinical Trials Unit at the Walton Centre for Neurology and Neurosurgery and similar units at the other participating regional trial centres. There will be a planned interim analysis at 18 months of the study. At the end of the study, the participants will receive a letter explaining the results found. To prevent any 'researcher bias', each participating centre will have a treating physician and an examining physician. The treating physician will recruit and treat the patients whereas the examining physician will do all baseline and follow-up examinations. The examining physician would be unaware or 'blinded' as to which treatment the patient is receiving and thus eliminating bias.
Intervention type
Drug
Phase
Not Specified
Drug names
Mitoxantrone and Glatiramer Acetate (Copaxone) vs Interferon Beta
Primary outcome measure
Multiple Sclerosis Impact Scale (MSIS) and Expanded Disability Status Scale (EDSS)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2005
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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).
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2005
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Walton Centre for Neurology and Neurosugery
Liverpool
L9 7LJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Walton Centre for Neurology and Neurosurgery NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list