A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device

Phase 4 Completed 93 enrolled Merck KGaA, Darmstadt, Germany

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2013-02-28
Primary completion: 2016-02-29
Completion: 2016-02-29

Publications

Landtblom AM, Guala D, Martin C, Olsson-Hau S, Haghighi S, Jansson L, Fredrikson S. RebiQoL: A randomized trial of telemedicine patient support program for health-related quality of life and adherence in people with MS treated with Rebif. PLoS One. 2019 Jul 5;14(7):e0218453. doi: 10.1371/journal.pone.0218453. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Interferon beta-1a	Protein / enzyme biologic	22 ug	Subcutaneous
Background	Interferon beta-1a	Protein / enzyme biologic	44 ug	Subcutaneous

A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device

Summary

Timeline

Publications

Drugs

Indications