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

ISRCTN	ISRCTN31557558
DOI	https://doi.org/10.1186/ISRCTN31557558
Secondary identifying numbers	N0259157815

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 31/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mike Boggild
Scientific

The Walton Centre for Neurology and Neurosugery
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/02/2005
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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).
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/2005
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Walton Centre for Neurology and Neurosugery

Liverpool
L9 7LJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The Walton Centre for Neurology and Neurosurgery NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan