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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier:
NCT00819000
First received: January 7, 2009
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Multiple Sclerosis
 Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2878
Study Start Date: December 2008
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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®
  • Avonex®
  • Rebif®
  • Betaseron®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819000

Locations
United States, Michigan
Teva Investigational Site
Swartz Creek, Michigan, United States
United States, Ohio
Teva Investigational Site
Columbus, Ohio, United States
United States, Pennsylvania
Teva Investigational Site
Carnegie, Pennsylvania, United States
Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
Study Chair: MerriKay Oleen-Burkey, PhD Teva Neuroscience, Inc.
Study Director: Howard Zwibel, MD Neurologic Center of South Florida
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier: NCT00819000     History of Changes
Other Study ID Numbers: PM032
Study First Received: January 7, 2009
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceutical Industries:
Specialty Pharmacy
Therapy Management
Medication Compliance
 Medication Adherence
Medication Persistence
Health Outcomes

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Copolymer 1
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 16, 2013