COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
Information source: Biogen Idec
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting
Phase: N/A
Status: Recruiting
Sponsored by: Biogen Idec Official(s) and/or principal investigator(s):
Marcelo Kremenchutzky, MD, Principal Investigator, Affiliation: University Hospital, London Health Sciences Centre
Overall contact:
Stuart St.Amand, Phone: 905-681-6551, Ext: 271, Email: sstamand@innomar-strategies.com
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: Other, Other
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
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
Stuart St.Amand, Phone: 905-681-6551, Ext: 271, Email: sstamand@innomar-strategies.com
University Hospital, London Health Sciences Centre, London, Ontario N6A 5A5, Canada; Recruiting
Additional Information
Starting date: May 2008
Ending date: February 2011
Last updated: April 22, 2009
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