Relapsing-Remitting Multiple Sclerosis Clinical Trial
Official title:
A Prospective Analysis of MS Patients After Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment
This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study to investigate whether baseline treatment with high-dose interferon beta 1a (Rebif 44 μg x 3 ), administered at a high frequency, leads to maintenance of stabilisation of the course of the disease in MS subjects previously treated with mitoxantrone. The previous mitoxantrone treatment of the included MS subjects was conducted in the course of a so-called escalation according to the immunomodulatory escalation treatment plan. An additional important aspect of the problem was the collection of safety and tolerance data during the observation phase.
The treatment of relapsing-remitting MS with interferon-beta has established itself as
first-choice treatment. In previous clinical studies, the interferon-beta 1a (Rebif) used
within the scope of this PMS study has demonstrated significant efficacy in all aspects of
treatment - magnetic resonance imaging (MRI) data, relapse rate, progression of disability
of MS. The PRISMS-4 study demonstrated that treatment with Rebif reduces the frequency and
severity of clinical relapses over 4 years and slows the progression of disability.
In the course of treatment escalation according to the Multiple Sklerose Therapie Konsensus
Gruppe (MSTKG) guidelines, MS subjects with correspondingly high disease activity were
predominantly put on mitoxantrone. The duration of treatment is on principle limited by a
cumulative lifelong total dose of 140 mg/m2 body surface area, which may not be exceeded due
to the known cardiologic adverse effects. If the cumulative mitoxantrone maximum dose is
reached and if the subject is in a stable condition, the question of further treatment
options presents itself. One possibility is the so-called 'deescalation', that is, the
return to immunomodulating baseline treatment.
Currently there is an increasing number of subjects who are in this phase of the disease and
are eligible for corresponding treatment decisions.
OBJECTIVES
Primary objective:
- To systematically investigate the safety, benefit and course of Rebif (44 μg x 3
),treatment in a larger number of subjects and to subject these data to standardized
analysis
;
Observational Model: Case-Only, Time Perspective: Prospective
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