Therapy Optimization in Multiple Sclerosis (MS)

NCT ID: NCT00819000

Last Updated: 2013-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2878 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Other Intervention Names

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Copaxone® Avonex® Rebif® Betaseron®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Neuroscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MerriKay Oleen-Burkey, PhD

Role: STUDY_CHAIR

Teva Neuroscience, Inc.

Howard Zwibel, MD

Role: STUDY_DIRECTOR

Neurologic Center of South Florida

Locations

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Teva Investigational Site

Swartz Creek, Michigan, United States

Site Status

Teva Investigational Site

Columbus, Ohio, United States

Site Status

Teva Investigational Site

Carnegie, Pennsylvania, United States

Site Status

Countries

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United States

References

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Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H. Therapy Optimization in Multiple Sclerosis: a cohort study of therapy adherence and risk of relapse. Mult Scler Relat Disord. 2015 Jan;4(1):75-82. doi: 10.1016/j.msard.2014.09.214. Epub 2014 Oct 7.

Reference Type DERIVED
PMID: 25787057 (View on PubMed)

Coyle PK, Cohen BA, Leist T, Markowitz C, Oleen-Burkey M, Schwartz M, Tullman MJ, Zwibel H. Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes. BMC Neurol. 2014 Mar 13;14:49. doi: 10.1186/1471-2377-14-49.

Reference Type DERIVED
PMID: 24624979 (View on PubMed)

Other Identifiers

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PM032

Identifier Type: -

Identifier Source: org_study_id

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