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 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Glatiramer Glatiramer acetate

U.S. FDA Resources

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
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Teva Neuroscience, Inc.

Investigators


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

More Information

Additional 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:	Siyu Liu, Senior Director of Pan Am Clinical Operations, Teva Neuroscience
ClinicalTrials.gov Identifier:	NCT00240006 History of Changes
Other Study ID Numbers:	PM024
Study First Received:	October 13, 2005
Last Updated:	April 8, 2011
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 29, 2016