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COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS (COMPASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00675883
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : January 30, 2012
Sponsor:
Information provided by:
Biogen

Study Description
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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.

Condition or disease
Multiple Sclerosis, Relapsing-Remitting

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
Study Design
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Study Type : Observational
Actual Enrollment : 1000 participants
Official Title: COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
Study Start Date : May 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Prospective
500 patients who will be enrolled in the MS Alliance program will be consented to participate in this study.
Retrospective
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.


Outcome Measures
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Primary Outcome Measures :
  1. Compliance with therapy in the prospective arm [ Time Frame: Week 7-10 and Week 80-83 ]
  2. Persistence on therapy between prospective and retrospective arms [ Time Frame: 22 months ]

Secondary Outcome Measures :
  1. Patients' satisfaction with new MSA program [ Time Frame: Week 7-10 and Week 80-83 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled in the MS AllianceTM program
Criteria

Inclusion Criteria:

  • Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
  • Prescription of AVONEX® PS (prefilled syringes)
  • Enrolment in the MS AllianceTM program
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675883


Locations
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Canada, Ontario
University Hospital, London Health Sciences Centre
London, Ontario, Canada
Sponsors and Collaborators
Biogen
More Information
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Responsible Party: Vladimir Migounov, MD/Sr. Manager, Medical Affairs, Biogen Idec Canada Inc.
ClinicalTrials.gov Identifier: NCT00675883    
Other Study ID Numbers: AVX-CAN-0703
First Posted: May 12, 2008    Key Record Dates
Last Update Posted: January 30, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases