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) logo

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

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®

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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