Rebif Compliance Support Program - Assessing Needs in Multiple Sclerosis (AIMS)

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01080573
First received: March 3, 2010
Last updated: April 26, 2011
Last verified: April 2011
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Questionnaire Based Survey to Identify Issues With Patient Compliance and to Develop Solutions to Improve Rebif Compliance and Improve Patient Outcomes

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Discontinuation of Rebif treatment (yes or no) [ Time Frame: Data collection is expected to end 3 months after last subject is recruited ] [ Designated as safety issue: No ]

Enrollment: 1257
Study Start Date: January 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080573

Locations
United Kingdom
Bupa Home Healthcare
Harlow, Essex, United Kingdom, CM19 5GU
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Dr Gillian Shepherd, MD MRCP Merck Serono UK Ltd
  More Information

No publications provided

Responsible Party: Dr Gillian Shepherd, Medical Director, Merck Serono Ltd. UK, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01080573     History of Changes
Other Study ID Numbers: MMFM 100
Study First Received: March 3, 2010
Last Updated: April 26, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Merck KGaA:
Multiple sclerosis
Rebif
Interferon beta-1a

Additional relevant MeSH terms:
Multiple Sclerosis
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 April 15, 2014