Therapy Optimization in Multiple Sclerosis (MS) (TOP MS)

January 28, 2013 updated by: Teva Neuroscience, Inc.

TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies

The purpose of this study is to determine if higher compliance and adherence rates to drug therapy for MS result in better health outcomes than lower rates of therapy compliance and adherence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2878

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Swartz Creek, Michigan, United States
        • Teva Investigational Site
    • Ohio
      • Columbus, Ohio, United States
        • Teva Investigational Site
    • Pennsylvania
      • Carnegie, Pennsylvania, United States
        • Teva Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies

Description

Inclusion Criteria:

  • Male or female, 18 years of age or older, with a diagnosis of MS.
  • Being treated with Glatiramer Acetate (GA) or (IFN)-β
  • Receiving therapy from a participating Specialty Pharmacy

Exclusion Criteria:

  • Has any contraindication to GA or IFN-β therapy, including pregnancy, trying to become pregnant, or breast feeding during the study
  • Has received an experimental drug in the last thirty (30) days other than Fampridine SR (4-aminopyridine or 4-AP)
  • Unlikely to be able to participate for the full two years of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treated MS Subjects
Subjects who are treated with Glatiramer Acetate or Interferon (IFN)-β and receive their therapy from one of the participating Specialty Pharmacies
Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b
MS therapies (listed above) used according to prescribers' instructions.
Other Names:
  • Copaxone®
  • Rebif®
  • Avonex®
  • Betaseron®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes
Time Frame: 12 months and 24 months
12 months and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Relationship of therapy adherence, defined as the accumulation of time from initiation to discontinuation of therapy and measured by time, to patient outcomes
Time Frame: 12 months and 24 months
12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Neuroscience, Inc.

Investigators

  • Study Chair: MerriKay Oleen-Burkey, PhD, Teva Neuroscience, Inc.
  • Study Director: Howard Zwibel, MD, Neurologic Center of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (ESTIMATE)

January 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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