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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00675883
First received: May 8, 2008
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Multiple Sclerosis, Relapsing-Remitting

Study Type: Observational
Official Title: COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Compliance with therapy in the prospective arm [ Time Frame: Week 7-10 and Week 80-83 ] [ Designated as safety issue: No ]
  • Persistence on therapy between prospective and retrospective arms [ Time Frame: 22 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients' satisfaction with new MSA program [ Time Frame: Week 7-10 and Week 80-83 ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: May 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675883

Locations
Canada, Ontario
University Hospital, London Health Sciences Centre
London, Ontario, Canada
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Vladimir Migounov, MD/Sr. Manager, Medical Affairs, Biogen Idec Canada Inc.
ClinicalTrials.gov Identifier: NCT00675883     History of Changes
Other Study ID Numbers: AVX-CAN-0703
Study First Received: May 8, 2008
Last Updated: January 26, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Multiple Sclerosis
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
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013