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COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS (COMPASS)
This study is currently recruiting participants.
Verified by Biogen Idec, May 2008
Sponsored by: Biogen Idec
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00675883
  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

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Interferon beta 1a
U.S. FDA Resources
Study Type: Observational
Official Title: COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS

Further study details as provided by Biogen Idec:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 1000
Study Start Date: May 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (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 from Innomar. 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

Contacts
Contact: Stuart St.Amand 905-681-6551 ext 271 sstamand@innomar-strategies.com

Locations
Canada, Ontario
University Hospital, London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Biogen Idec
Investigators
Principal Investigator: Marcelo Kremenchutzky, MD University Hospital, London Health Sciences Centre
  More Information

Responsible Party: Biogen Idec Canada Inc. ( Vladimir Migounov, MD/Sr. Manager, Medical Affairs )
Study ID Numbers: AVX-CAN-0703
Study First Received: May 8, 2008
Last Updated: May 9, 2008
ClinicalTrials.gov Identifier: NCT00675883  
Health Authority: Canada: Ethics Review Committee

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009