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 (RebiQoL)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Relapsing-Remitting; Multiple Sclerosis

Treatments: Drug: Rebif®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01791244

2012-004887-22 (EudraCT Number)

EMR 200136-560

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 18 or older
• A diagnosis of relapsing-remitting multiple sclerosis according to the revised McDonald Criteria (2010)
• Treatment with Rebif® 22 or 44 mcg subcutaneously three times a week in accordance to the Summary of product characteristics
• Rebif® administered by the RebiSmart™ device
• Provided a signed informed consent form

Exclusion criteria

• Has received any components, except for technical support, of MinSupport Plus prior to study entry
• Has difficulty reading and/or understanding Swedish
• Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
• No access to computer
• Participation in another clinical study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 2 patient groups

Technical support for the RebiSmart™ device

Active Comparator group

Description:

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.

Treatment:

Drug: Rebif®

Subject support program (MinSupport Plus)

Experimental group

Description:

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.

Treatment:

Drug: Rebif®