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OpenTrials
Completed

NCT Number: NCT00675883

COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, London Health Sciences Centre

London, Ontario, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
  • Prescription of AVONEX® PS (prefilled syringes)
  • Enrolment in the MS AllianceTM program

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Patients' satisfaction with new MSA program

    Time frame: Week 7-10 and Week 80-83

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Acronym: COMPASS

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 12, 2008
Registry last updated
Jan 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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