Therapy Optimization in Multiple Sclerosis (MS) - Full Text View

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00819000

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 (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.

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, 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 cedwards@diplomatpharmacy.com
United States, Ohio
BioScrip, Inc.	Not yet recruiting
Columbus, Ohio, United States, 43228
Contact: Kira Botkin, BA 614-850-1230 kbotkin@bioscrip.com

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

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
ClinicalTrials.gov 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
Interferons
Interferon beta-1b

Interferon beta 1a
Interferon-beta
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
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

ClinicalTrials.gov processed this record on January 13, 2009