NCT01791244

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_4 multiple-sclerosis

Timeline
Completed

Started Feb 2013

Typical duration for phase_4 multiple-sclerosis

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

February 28, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 12, 2017

Completed
Last Updated

August 24, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

February 12, 2013

Results QC Date

April 19, 2017

Last Update Submit

July 21, 2017

Conditions

Multiple SclerosisRelapsing-Remitting

Keywords

Multiple SclerosisRelapsing-RemittingRebifRebiSmartPatient support program

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12

    Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning.

    Baseline and Month 12

Secondary Outcomes (15)

  • Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6

    Baseline and Month 6

  • Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12

    Baseline, Month 6 and 12

  • Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12

    Baseline, Month 6 and 12

  • Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Visual Analogue Scale (VAS) Scale at Month 6 and 12

    Baseline, Month 6 and 12

  • Percentage of Subjects With Treatment Adherence at Month 6 and 12

    Month 6 and 12

  • +10 more secondary outcomes

Study Arms (2)

Technical support for the RebiSmart™ device

ACTIVE COMPARATOR

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.

Drug: Rebif®

Subject support program (MinSupport Plus)

EXPERIMENTAL

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.

Drug: Rebif®

Interventions

Rebif®DRUG
Subject support program (MinSupport Plus)Technical support for the RebiSmart™ device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Please contact the Merck Communications Service for Recruiting locations

Darmstadt, Germany

Location

Research site

Angered, Sweden

Location

Research site

Ängelholm, Sweden

Location

Research Site

Danderyd, Sweden

Location

Research Site

Eksjö, Sweden

Location

Research Site

Gävle, Sweden

Location

Research Site

Karlstad, Sweden

Location

Research Site

KS Huddinge, Sweden

Location

Research Site

Linköping, Sweden

Location

Research Site

Malmö/Lund, Sweden

Location

Research Site

Motala, Sweden

Location

Research Site

Örnsköldsvik, Sweden

Location

Research Site

Skövde, Sweden

Location

Research Site

Trollhättan, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 31276502DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Merck KGaA Communication Center
Organization
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
service@merckgroup.com
+49-6151-72-5200

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 13, 2013

Study Start

February 28, 2013

Primary Completion

February 29, 2016

Study Completion

February 29, 2016

Last Updated

August 24, 2017

Results First Posted

July 12, 2017

Record last verified: 2017-07

Locations

DE(1)SE(13)