A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone - Full Text View

Purpose

To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample of MS patients who are at high risk of nonadherence and receive support from Shared Solutions® and their MS Center versus those who receive support only from Shared Solutions®.

Condition	Intervention	Phase
Multiple Sclerosis	Procedure: Shared Solutions® plus MS Center v. Shared Solutions®	Phase IV

MedlinePlus related topics:

Multiple Sclerosis

ChemIDplus related topics:

Copolymer 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Official Title:	An Open Label, Prospective Parallel Cohort Study Comparing A 90-Day Copaxone® Adherence Enhancement Program Among Persons With Multiple Sclerosis Who Participate in Shared Solutions® Alone or in Partnership With Their MS Center

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Adherence rate of Copaxone therapy by procedural intervention [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compliance of treatment, positive experience of treatment, levels of depression, proportion of time spent, self injection competency ratings, and the risk of non-adherence/non-compliance [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment:	307
Study Start Date:	January 2006
Study Completion Date:	September 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Shared Solutions®	Procedure: Shared Solutions® plus MS Center v. Shared Solutions® Copaxone
2: Experimental Shared Solutions® and MS Center/Office Practice Partnership	Procedure: Shared Solutions® plus MS Center v. Shared Solutions® Copaxone

Detailed Description:

An Open Label, Prospective Parallel Cohort Design. Participants will be assigned to one of two conditions:

CONDITION A: Shared Solutions® CONDITION B: Shared Solutions® & MS Center Partnership

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females, 18 years of age or older.
Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted).
Beginning or restarting therapy with Glatiramer Acetate (Copaxone®).
Willing and able to complete all procedures and evaluations related to the study.
Willing to provide informed consent.

Exclusion Criteria:

Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®.
Has a significant medical illness other than MS that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.
Pregnant or trying to become pregnant, or breast feeding during the study.
Previously participated in this study or another clinical research study in the past 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240006

Show 23 Study Locations

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators


Study Director:	MerriKay Oleen-Burkey, Ph.D.	Teva Neuroscience, Inc.

More Information

For more information about Multiple Sclerosis This link exits the ClinicalTrials.gov site

For more information about Shared Solutions This link exits the ClinicalTrials.gov site

For more information about Teva Neuroscience, Inc. This link exits the ClinicalTrials.gov site

Responsible Party:	Teva Neuroscience ( Siyu Liu, Senior Director of Pan Am Clinical Operations )
Study ID Numbers:	PM024
First Received:	October 13, 2005
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00240006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:

Multiple Sclerosis

Copaxone®

Shared Solutions®

Study placed in the following topic categories:

Copolymer 1

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes

Immune System Diseases

Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00240006