Background to trial
A research team at the Walton Centre for Neurology and Neurosurgery in Liverpool have developed a new treatment protocol for patients with very active relapsing-remitting multiple sclerosis (RRMS). This new protocol uses mitoxantrone followed by glatiramer acetate (Copaxone®) as maintenance disease-modifying therapy. The combination has proved successful in reducing relapses and slowing disease progression amongst the 27 patients treated so far (only two relapses occurred in the group of 27 whilst on GA monotherapy for up to 40 months after withdrawal of mitoxantrone).
A two-arm single blinded study is now being initiated at 10 centres across the UK to examine the combination further and we are looking to enrol suitable patients with RRMS to take part. To participate in the trial you must have the consent of your MS specialist and funding from your local Health Authority or PCT.
The study will compare this combination therapy with high dose interferon beta (Rebif® 44) in patients with early active RRMS.
Study overview
Subjects identified as potentially eligible for the trial will only be enrolled to the study following the completion of a series of screening procedures. These will take place in an outpatient-screening visit and will involve various examinations including a neurological examination (by treating physician), physical examination, vital signs, blood tests, MSIS, EDSS and ARR.
After screening eligible subjects will undergo a pre-induction visit with safety blood testing and a pregnancy test.
Those confirmed as eligible will then be randomised into Group MX-GA (induction arm) and Group Interferon (comparison arm).
Patients in Group MX-GA will receive three monthly infusions of mitoxantrone before beginning treatment with glatiramer acetate at month 3. They will then continue daily injections of glatiramer acetate for 33 months. The total treatment period for Group MX-GA will be 36 months.
Patients in treatment Group Interferon will start treatment with Interferon (Rebif® 44) and will continue with three times weekly dosing for 36 months.
Subjects in both groups will be assessed routinely throughout the course of the study. Unscheduled visits for the evaluation of symptoms suggestive of relapses will also take place.
We are seeking to recruit sixty (60) patients to the study. Thirty (30) will be randomised to treatment Group MX-GA and thirty (30) patients into treatment Group Interferon.
If you are interested in participating then please fill in the enquiry form to find out if you are eligible for further screening tests and potential recruitment to the study.
You will need to register prior to completing the form.
If you are found to be eligible for further screening your completed application will be sent to the study co-ordinator who will then contact you with further information regarding participation in the study.
If you are found to be ineligible you will be notified accordingly and directed to other sites which will give you further information about MS and available treatment options.