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Therapy Optimization in Multiple Sclerosis (MS) (TOP MS)

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ClinicalTrials.gov Identifier: NCT00819000
Recruitment Status : Completed
First Posted : January 8, 2009
Last Update Posted : January 29, 2013
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )

Tracking Information
First Submitted Date January 7, 2009
First Posted Date January 8, 2009
Last Update Posted Date January 29, 2013
Study Start Date December 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2009)
Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes [ Time Frame: 12 months and 24 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00819000 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 7, 2009)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Multiple 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.
Other Names:
  • Copaxone®
  • Avonex®
  • Rebif®
  • Betaseron®
Study Groups/Cohorts 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
Intervention: Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 28, 2013)
2878
Original Estimated Enrollment
 (submitted: January 7, 2009)
3000
Actual Study Completion Date January 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00819000
Other Study ID Numbers PM032
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
Study Sponsor Teva Neuroscience, Inc.
Collaborators Not Provided
Investigators
Study Chair: MerriKay Oleen-Burkey, PhD Teva Neuroscience, Inc.
Study Director: Howard Zwibel, MD Neurologic Center of South Florida
PRS Account Teva Pharmaceutical Industries
Verification Date January 2013