Rebif Compliance Support Program - Assessing Needs in Multiple Sclerosis

NCT ID: NCT01080573

Last Updated: 2014-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1257 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-04-30

Brief Summary

This 1-arm, open-label, multicentric, observational study aims to collect subject centric information in line with routine care. Subjects' expectations of therapy, side effect management and lifestyle may influence adherence to therapy. This survey aims to determine whether such factors and/or others affect the successful initiation and maintenance of Rebif therapy.

The data collected during this study will include information on the subject's treatment including expectations, experience, training and support. The results of the study will be used to understand the impact on subjects' compliance and tailor training and support services to subject's need. It will also be made available to other healthcare organisations involved in the subjects treatment.

Detailed Description

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system and is one of the most common causes of neurological disability in young adults. It is characterised by multifocal, recurrent attacks of neurological symptoms and signs with variable recovery. Eventually the majority of subjects develop a progressive clinical course. It is important to carefully initiate and maintain subjects with MS on therapy. Information will be gathered in a structured way which will enable easier identification of any subgroups of subjects who may be at risk of poor compliance. These risk groups could possibly include groups with particular attributes such as poor information at the start of treatment, unrealistic expectations or a particular life style. This study will be conducted during the contact with the subject necessary to deliver the homecare service. Participants will be contacted by Bupa Home Healthcare Multiple Sclerosis subject coordinators by telephone to conduct specific questionnaires during the 4 stages of the subject's treatment i.e. pre-installation of treatment, post installation of treatment, monthly pre delivery of drug and at a subject's end treatment.

OBJECTIVES

• To collect subject centric information in line with routine care including subject's expectations of therapy, side effect management and lifestyle may influence adherence to therapy
• To determine whether such factors and/or others affect the successful initiation and maintenance of Rebif therapy

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Subjects who have been prescribed Rebif and referred to Bupa Home Healthcare service by one of the participating referring centres

Exclusion Criteria

• Subject unwilling to give informed consent
• Subjects visiting private clinics

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Merck Serono Ltd. UK, an affiliate of Merck KGaA, Darmstadt, Germany

Principal Investigators

Dr Gillian Shepherd, MD MRCP

Role: STUDY_DIRECTOR

Merck Serono UK Ltd

Locations

Bupa Home Healthcare

Harlow, Essex, United Kingdom

Countries

United Kingdom

Other Identifiers

MMFM 100

Identifier Type: -

Identifier Source: org_study_id