COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS (COMPASS)
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Completed
Phase
Locations
Canada
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Multiple Sclerosis, Relapsing-Remitting
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
- Prescription of AVONEX® PS (prefilled syringes)
- Enrolment in the MS AllianceTM program
Sites / Locations
- University Hospital, London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
Prospective
Retrospective
Arm Description
500 patients who will be enrolled in the MS Alliance program will be consented to participate in this study.
500 patient chart reviews will be completed for patients who were enrolled in the MS Alliance program between two (2) to three (3) years ago.
Outcomes
Primary Outcome Measures
Compliance with therapy in the prospective arm
Persistence on therapy between prospective and retrospective arms
Secondary Outcome Measures
Patients' satisfaction with new MSA program
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00675883
Brief Title
COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
Acronym
COMPASS
Official Title
COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
Study Type
Observational
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A phase IV, observational, survey-based study to measure compliance with Avonex® PS therapy in patients with Relapsing-Remitting Multiple Sclerosis, and to compare persistence on therapy 22 months after initial prescription of AVONEX® PS between patients enrolled in the current MS AllianceTM program versus patients enrolled in this program prior to October 2007.
Detailed Description
Study Design
Five hundred patients will be enrolled in the prospective portion of the study, all of whom will receive AVONEX. Patients will join the study by signing the attached Informed Consent Form (Appendix 1) at their doctor's office at the time of prescription. Innomar will provide the drug to approximately 40 new patients per month, so it will take about twelve to fourteen months to enroll all of the study subjects, assuming that all agree to participate. Once the recruitment period is over, it will take another 22 months to complete the study to the 22-months point for the last subject.
In the retrospective arm of the study, 500 chart reviews will be completed for patients who had participated in the MS Alliance program two (2) to three (3) years ago to determine persistence to therapy over a similar 22 month period.
Study Objectives
Primary Objectives:
- To assess patients' compliance (as defined above) with AVONEX therapy in the prospective arm using self-reported patients questionnaire, as well as to compare patients' persistence on therapy (as defined above) between prospective and retrospective arms.
Secondary Objective:
- Evaluate patients' satisfaction with new MSA program.
Patients and Methods
Only patients enrolled in the MSA program will be included in this study. There will be no interventions above the current standard of care with the MSA program. Two distinct patient arms will exist for this study: the prospective arm and the retrospective (chart review) arm.
Inclusion Criteria
Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
Prescription of AVONEX® PS (prefilled syringes)
Enrolment in the MS AllianceTM program
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
7. Study Design
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prospective
Arm Description
500 patients who will be enrolled in the MS Alliance program will be consented to participate in this study.
Arm Title
Retrospective
Arm Description
500 patient chart reviews will be completed for patients who were enrolled in the MS Alliance program between two (2) to three (3) years ago.
Primary Outcome Measure Information:
Title
Compliance with therapy in the prospective arm
Time Frame
Week 7-10 and Week 80-83
Title
Persistence on therapy between prospective and retrospective arms
Time Frame
22 months
Secondary Outcome Measure Information:
Title
Patients' satisfaction with new MSA program
Time Frame
Week 7-10 and Week 80-83
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
Prescription of AVONEX® PS (prefilled syringes)
Enrolment in the MS AllianceTM program
Study Population Description
Patients enrolled in the MS AllianceTM program
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
University Hospital, London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
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