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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
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 8, 2008
Last Updated
January 26, 2012
Sponsor
Biogen
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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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