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

March 3, 2010
April 26, 2011
January 2007
April 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01080573 on ClinicalTrials.gov Archive Site
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Rebif Compliance Support Program - Assessing Needs in Multiple Sclerosis
A Questionnaire Based Survey to Identify Issues With Patient Compliance and to Develop Solutions to Improve Rebif Compliance and Improve Patient Outcomes

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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Multiple Sclerosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1257
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01080573
MMFM 100
No
Dr Gillian Shepherd, Medical Director, Merck Serono Ltd. UK, an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA
Not Provided
Study Director: Dr Gillian Shepherd, MD MRCP Merck Serono UK Ltd
Merck KGaA
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP