A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Multiple Sclerosis	Procedure: Shared Solutions® plus MS Center v. Shared Solutions®	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	307 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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
Study Start Date :	January 2006
Actual Primary Completion Date :	January 2007
Actual Study Completion Date :	September 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Shared Solutions®	Procedure: Shared Solutions® plus MS Center v. Shared Solutions®; Copaxone
Experimental: 2; Shared Solutions® and MS Center/Office Practice Partnership	Procedure: Shared Solutions® plus MS Center v. Shared Solutions®; Copaxone

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Adherence rate of Copaxone therapy by procedural intervention [ Time Frame: 90 days ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®.
2. 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.
3. Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.
4. Pregnant or trying to become pregnant, or breast feeding during the study.
5. Previously participated in this study or another clinical research study in the past 30 days.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Teva Neuroscience, Inc.

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

For more information about Multiple Sclerosis 

For more information about Shared Solutions 

For more information about Teva Neuroscience, Inc. 

Responsible Party:	Siyu Liu, Senior Director of Pan Am Clinical Operations, Teva Neuroscience
ClinicalTrials.gov Identifier:	NCT00240006 History of Changes
Other Study ID Numbers:	PM024
First Posted:	October 17, 2005
Last Update Posted:	April 11, 2011
Last Verified:	April 2011

Keywords provided by Teva Pharmaceutical Industries:

Multiple Sclerosis; Copaxone®; Shared Solutions®

Additional relevant MeSH terms:

Sclerosis; Multiple Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases	Immune System Diseases; Pharmaceutical Solutions; Glatiramer Acetate; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Immunosuppressive Agents; Antirheumatic Agents