Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif®

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is planned to evaluate the cognitive functions in subjects with RRMS treated with interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck spol.s.r.o., Czech Republic
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Subjects diagnosed with RRMS

• Subjects eligible for treatment with Rebif as per SmPC, the Czech local guidelines and the actual Health insurance policy.

• Subjects 18-65 years of age

• Subjects with EDSS score < 4

• Subjects who are willing and able to give informed consent

Exclusion Criteria:

• Treatment with Rebif for more than 24 months prior the informed consent form has been obtained.

• Subjects with history of hypersensitivity to natural or recombinant interferon-β, or to any excipients

• Female subject who is pregnant or breast feeding and/or planning to become pregnant

• Subjects with current severe depression and/or suicidal ideation

• Any contraindication for Rebif therapy as per SmPC

• Subjects with severe disability and/or any neurologic or psychiatric condition that may interfere with test performance

• Prior treatment with interferon beta-1a i.m. or interferon beta-1b or glatiramer acetate.