Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
31/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mike Boggild

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes