COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS (COMPASS)
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|ClinicalTrials.gov Identifier: NCT00675883|
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : January 30, 2012
|Condition or disease|
|Multiple Sclerosis, Relapsing-Remitting|
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.
- 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.
- 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.
- Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
- Prescription of AVONEX® PS (prefilled syringes)
- Enrolment in the MS AllianceTM program
|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|
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.
- Compliance with therapy in the prospective arm [ Time Frame: Week 7-10 and Week 80-83 ]
- Persistence on therapy between prospective and retrospective arms [ Time Frame: 22 months ]
- Patients' satisfaction with new MSA program [ Time Frame: Week 7-10 and Week 80-83 ]
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
|University Hospital, London Health Sciences Centre|
|London, Ontario, Canada|