Therapy Optimization in Multiple Sclerosis (MS) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Therapy Optimization in Multiple Sclerosis (MS)

Official Title ^†

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

Brief Summary

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.

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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Multiple Sclerosis

Intervention ^†

Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcu), and IFN-beta 1b

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

3000

Start Date ^†

December 2008

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00819000

Organization ID

PM032

Secondary IDs ^††

Study Sponsor ^†

Teva Pharmaceutical Industries

Collaborators ^††

Investigators ^†

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

Information Provided By

Teva Pharmaceutical Industries

Verification Date

January 2009

First Received Date ^†

January 7, 2009

Last Updated Date

January 7, 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.