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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240006
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : April 11, 2011
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Description
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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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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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240006


Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
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Study Director: MerriKay Oleen-Burkey, Ph.D. Teva Neuroscience, Inc.
More Information
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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

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Responsible Party: Siyu Liu, Senior Director of Pan Am Clinical Operations, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00240006    
Other Study ID Numbers: PM024
First Posted: October 17, 2005    Key Record Dates
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:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Glatiramer Acetate
Pharmaceutical Solutions
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents