An Observational Study Evaluating Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in Multiple Sclerosis (MS) Patients

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This was an observational, single arm, multicentric study conducted for the adjustment of treatment strategy and its monitoring using high-frequency and high-dosage administration of interferon-beta (Rebif) in MS subjects. Study focussed on assessment of the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Gesellschaft für Therapieforschung mbH
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Subjects with clinically ensured diagnosis of a MS and history of attacks or episodes

• Subjects who were on one of the permitted basis therapies at least since 6 months

• Subjects with existing systemic concurrent diseases (e.g.diabetes, heart, liver, kidney diseases) should be monitored very carefully.

Exclusion Criteria:

• Subjects with secondary progressive course of the MS without attacks or episodes, pregnant or nursing subjects as well as subjects with history of contraindications