Conditions: Multiple Sclerosis Relapsing-Remitting
Keywords: Multiple Sclerosis Relapsing-Remitting Rebif RebiSmart Patient support program
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 93
Healthy volunteers: no

Brief summary:
This is a randomized, comparative, and multicenter study to assess the impact of a patient support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™ device.

Detailed description:

Arms:
arm 1: Subjects will be administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with technical support for RebiSmart. arm 2: Subjects will be administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.

Interventions: intervention 1: Rebif®
Intervention descriptions: intervention 1: None

Protocol document: