Clinical trial NCT00675883: COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
Official title: COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-05-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in the MS AllianceTM program

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.

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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Compliance with therapy in the prospective arm
timeFrame: Week 7-10 and Week 80-83
measure: Persistence on therapy between prospective and retrospective arms
timeFrame: 22 months
Secondary outcomes:
measure: Patients' satisfaction with new MSA program
timeFrame: Week 7-10 and Week 80-83
Other outcomes:
Locations:
city: London
country: Canada
facility: University Hospital, London Health Sciences Centre
state: Ontario
Study officials:
References: