Therapy Optimization in Multiple Sclerosis (MS)

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Health Behavior Immune System Diseases Medication Adherence Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Teva Investigational Site, Swartz Creek, Michigan, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b

Drug

MS therapies (listed above) used according to prescribers' instructions.

Other names: Copaxone®, Avonex®, Rebif®, Betaseron®

Primary outcomes

Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes

Time frame: 12 months and 24 months

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Teva Neuroscience, Inc.

Industry

Registry information

Official study title

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

Acronym: TOP MS

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2013
First posted: Jan 8, 2009
Registry last updated: Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed