NCT00819000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,878

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

4 years

First QC Date

January 7, 2009

Last Update Submit

January 28, 2013

Conditions

Multiple Sclerosis

Keywords

Specialty PharmacyTherapy ManagementMedication ComplianceMedication AdherenceMedication PersistenceHealth Outcomes

Outcome Measures

Primary Outcomes (1)

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

    12 months and 24 months

Secondary Outcomes (1)

  • 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

Study Arms (1)

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

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

Interventions

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

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

Also known as: Copaxone®, Avonex®, Rebif®, Betaseron®
Treated MS Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Teva Investigational Site

Swartz Creek, Michigan, United States

Location

Teva Investigational Site

Columbus, Ohio, United States

Location

Teva Investigational Site

Carnegie, Pennsylvania, United States

Location

Related Publications (2)

  • 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.

    PMID: 25787057DERIVED

  • 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.

    PMID: 24624979DERIVED

MeSH Terms

Conditions

Multiple SclerosisMedication Adherence

Interventions

Glatiramer AcetateInjections, SubcutaneousInterferon beta-1aInterferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsInjectionsDrug Administration RoutesDrug TherapyTherapeuticsInterferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsProteinsBiological Factors

Study Officials

  • MerriKay Oleen-Burkey, PhD

    Teva Neuroscience, Inc.

    STUDY CHAIR

  • Howard Zwibel, MD

    Neurologic Center of South Florida

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

US(3)