NCT00675883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 30, 2012

Status Verified

January 1, 2012

Enrollment Period

3.6 years

First QC Date

May 8, 2008

Last Update Submit

January 26, 2012

Conditions

Outcome Measures

Primary Outcomes (2)

  • Compliance with therapy in the prospective arm

    Week 7-10 and Week 80-83

  • Persistence on therapy between prospective and retrospective arms

    22 months

Secondary Outcomes (1)

  • Patients' satisfaction with new MSA program

    Week 7-10 and Week 80-83

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled in the MS AllianceTM program

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, London Health Sciences Centre

London, Ontario, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 12, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 30, 2012

Record last verified: 2012-01

Locations