Therapy Optimization in Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

— TOP MS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819000
• Other study ID #: PM032
• Status: Completed
• Phase: N/A
• First received: January 7, 2009
• Last updated: January 28, 2013
• Start date: December 2008
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2878
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, 18 years of age or older, with a diagnosis of MS.

• Being treated with Glatiramer Acetate (GA) or (IFN)-ß

• Receiving therapy from a participating Specialty Pharmacy

Exclusion Criteria:

• Has any contraindication to GA or IFN-ß 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b
MS therapies (listed above) used according to prescribers' instructions.

Locations

Country	Name	City	State
United States	Teva Investigational Site	Carnegie	Pennsylvania
United States	Teva Investigational Site	Columbus	Ohio
United States	Teva Investigational Site	Swartz Creek	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Teva Neuroscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes		12 months and 24 months	No
Secondary	Relationship of therapy adherence, defined as the accumulation of time from initiation to discontinuation of therapy and measured by time, to patient outcomes		12 months and 24 months	No