An Observational Study of Multiple Sclerosis (MS) Patients Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment With Mitoxantrone

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Subjects with a clinically demonstrated diagnosis of MS and present relapses

• Subjects who were relapse-free for the past 6 months with an Expanded Disability Status Scale (EDSS) range between 2 and 6

• Subjects who had a stable disease status during the past few months

• The last administration of mitoxantrone had been more than 3 months previously. In addition, the mitoxantrone treatment was given for at least a 12-month period, but for not more than 24 months, within a total dosage of 60-120 mg/m2 body surface area

Exclusion Criteria:

• Subjects with MS with secondary progression (SPMS) without relapse activity, pregnant or breast-feeding patients, as well as subjects with contraindications

• Subjects with existing systemic concomitant diseases (e.g. diabetes, heart, liver or kidney diseases)