|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Biogen Idec |
|---|---|
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00675883 |
Purpose
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.
| Condition |
|---|
|
Multiple Sclerosis, Relapsing-Remitting |
| Study Type: | Observational |
| Official Title: | COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS |
| Estimated Enrollment: | 1000 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Prospective
500 patients who will be enrolled in the MS Alliance program will be consented to participate in this study.
|
|
Retrospective
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.
|
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:
Secondary Objective:
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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients enrolled in the MS AllianceTM program
Inclusion Criteria:
Contacts and Locations| Contact: Stuart St.Amand | 905-681-6551 ext 271 | sstamand@innomar-strategies.com |
| Canada, Ontario | |
| University Hospital, London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 5A5 | |
| Principal Investigator: | Marcelo Kremenchutzky, MD | University Hospital, London Health Sciences Centre |
More Information
| Responsible Party: | Biogen Idec Canada Inc. ( Vladimir Migounov, MD/Sr. Manager, Medical Affairs ) |
| Study ID Numbers: | AVX-CAN-0703 |
| Study First Received: | May 8, 2008 |
| Last Updated: | April 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00675883 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Interferon beta 1a |
Demyelinating Autoimmune Diseases, CNS Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
|
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases |
Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
