NCT01080573

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

July 31, 2014

Status Verified

April 1, 2011

Enrollment Period

4.2 years

First QC Date

March 3, 2010

Last Update Submit

July 30, 2014

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisRebifInterferon beta-1a

Outcome Measures

Primary Outcomes (1)

  • Discontinuation of Rebif treatment (yes or no)

    Data collection is expected to end 3 months after last subject is recruited

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bupa Home Healthcare

Harlow, Essex, CM19 5GU, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dr Gillian Shepherd, MD MRCP

    Merck Serono UK Ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 4, 2010

Study Start

January 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 31, 2014

Record last verified: 2011-04

Locations

GB(1)