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

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Phase: N/A

Status: Completed

Sponsored by: Biogen

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.

Clinical Details

Official title: COMPliance With Avonex PS in Patients With Relapsing-Remitting MS

Study design: N/A

Primary outcome:

Compliance with therapy in the prospective arm

Persistence on therapy between prospective and retrospective arms

Secondary outcome: Patients' satisfaction with new MSA program

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)

- Prescription of AVONEX® PS (prefilled syringes)

- Enrolment in the MS AllianceTM program

Locations and Contacts

University Hospital, London Health Sciences Centre, London, Ontario, Canada
Additional Information

Starting date: May 2008
Last updated: January 26, 2012

Page last updated: August 20, 2015

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