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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00240006
First received: October 13, 2005
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
  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:

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
Genders Eligible for Study:   Both
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
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 Teva Neuroscience, Inc.  This link exits the ClinicalTrials.gov site

No publications provided

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:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 23, 2013