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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Merck KGaA
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01791244
First received: February 12, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Relapsing-Remitting
Other: Technical support for the RebiSmart™ device
Other: Patient support program (MinSupport Plus)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Phase IV Multicenter Randomized Study to Assess the Impact of a Patient Support Program (MinSupport Plus) on Health Related Quality of Life (HRQoL) and Adherence in Patients With Relapsing Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart Device

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) psychological score at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) psychological score at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) total score at Month 6 and 12 [ Time Frame: Baseline, Month 6 and 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Euro Quality of Life Questionnaire with 5 questions alternatives (EQ5D-5L) score at Month 6 and 12 [ Time Frame: Baseline, Month 6 and 12 ] [ Designated as safety issue: No ]
  • Percentage of subjects with treatment adherence [ Time Frame: Month 6 and 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Fatigue Severity Scale score and Modified Fatigue Impact Scale score at Month 6 and 12 [ Time Frame: Baseline, Month 6 and 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Hospital Anxiety and Depression Scale score at Month 6 and 12 [ Time Frame: Baseline, Month 6 and 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Working ability per subject at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
  • Percentage of subjects with Adverse events [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Number of subjects with categorical score on subject satisfaction questionnaire [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Number of health care personnel with categorical score on Health Care Personnel satisfaction questionnaire [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Lifestyle questionnaire score in subjects receiving Min Support Plus at Month 6 and 12 [ Time Frame: Baseline, Month 6 and 12 ] [ Designated as safety issue: No ]
  • Number of subjects with Lifestyle goals score in subjects receiving Min Support Plus [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
  • Health economy as assessed by Quality of life questionnaire [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Technical support for the RebiSmart™ device Other: Technical support for the RebiSmart™ device
Rebif® will be administered by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) three times a week in accordance to the summary of product characteristics. Subjects will receive only technical support for the RebiSmart™ device.
Experimental: Patient support program (MinSupport Plus) Other: Patient support program (MinSupport Plus)
Rebif® will be administered by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) three times a week in accordance to the summary of product characteristics. Subjects will receive 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791244

Contacts
Contact: Merck KGaA Communication Center +49 6151 72 5200 service@merckgroup.com

Locations
Germany
Please contact the Merck Communications Service for Recruiting locations Recruiting
Darmstadt, Germany
Contact: Merck Communication Services    +49-6151-75-5200    service@merckgroup.com   
Sweden
Research Site Recruiting
Gävle, Sweden
Research Site Recruiting
Karlstad, Sweden
Research Site Recruiting
KS Huddinge, Sweden
Research Site Recruiting
Malmö/Lund, Sweden
Research Site Recruiting
Skövde, Sweden
Research Site Recruiting
Örnsköldsvik, Sweden
Sponsors and Collaborators
Merck KGaA
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01791244     History of Changes
Other Study ID Numbers: EMR 200136-560, 2012-004887-22
Study First Received: February 12, 2013
Last Updated: February 7, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Merck KGaA:
Multiple Sclerosis
Relapsing-Remitting
Rebif
RebiSmart
Patient support program

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014