Study 19 of 2431 for search of: received on or after 11/14/2008
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Therapy Optimization in Multiple Sclerosis (MS) (TOP MS)
This study is currently recruiting participants.
Verified by Teva Pharmaceutical Industries, January 2009
Sponsored by: Teva Pharmaceutical Industries
Information provided by: Teva Pharmaceutical Industries Identifier: NCT00819000

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 (Subcu), and IFN-beta 1b

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Interferon beta Interferon-beta Copolymer 1 Interferon beta 1a Interferon beta-1b
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 3000
Study Start Date: December 2008
Estimated Primary Completion Date: December 2011 (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 (Subcu), and IFN-beta 1b
MS therapies (listed above) used according to prescribers' instructions.

Detailed Description:

Specialty Pharmacies are a common source of drug supply for patients with MS. In addition to promoting and maintaining medication compliance and adherence to MS therapies, a few Specialty Pharmacies are taking their collaboration with health care providers further. They are managing the MS patients' adverse effects of medication, offering self-management tools and providing ongoing education to MS patients as well as assessing possible suboptimal medication response and notifying the health care providers about issues the patients are experiencing between their office visits. This study is being conducted in collaboration with Specialty Pharmacies that offer the full spectrum of patient services to those receiving glatiramer acetate and the beta interferons. It will examine the impact of various therapy compliance and adherence levels as well as other disease management factors that may influence patient health outcomes in MS over a two year period.


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


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 identifier: NCT00819000

United States, Illinois
(3) Walgreen Co. and its specialty pharmacy subsidiaries and affiliates, Not yet recruiting
Deerfield, Illinois, United States, 60015
United States, Michigan
Diplomat Specialty Pharmacy Recruiting
Swartz Creek, Michigan, United States, 48473
Contact: Cora L Edwards, BA, CCRP     810-720-6851    
United States, Ohio
BioScrip, Inc. Not yet recruiting
Columbus, Ohio, United States, 43228
Contact: Kira Botkin, BA     614-850-1230    
Sponsors and Collaborators
Teva Pharmaceutical Industries
Study Chair: MerriKay Oleen-Burkey, PhD Teva Neuroscience, Inc.
Study Director: Howard Zwibel, MD Neurologic Center of South Florida
  More Information

Responsible Party: Teva Neuroscience ( MerriKay Oleen-Burkey, PhD. Director, Outcomes Research )
Study ID Numbers: PM032
Study First Received: January 7, 2009
Last Updated: January 7, 2009 Identifier: NCT00819000  
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

Study placed in the following topic categories:
Copolymer 1
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferon beta-1b
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Anti-Infective Agents
Pathologic Processes
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions processed this record on January 16, 2009