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

This study has been completed.
Information provided by:
Teva Pharmaceutical Industries Identifier:
First received: October 13, 2005
Last updated: April 8, 2011
Last verified: April 2011
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
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

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Adherence rate of Copaxone therapy by procedural intervention [ Time Frame: 90 days ]

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 ]

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®
Experimental: 2
Shared Solutions® and MS Center/Office Practice Partnership
Procedure: Shared Solutions® plus MS Center v. Shared Solutions®


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

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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Please refer to this study by its identifier: NCT00240006

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

Additional Information:
Responsible Party: Siyu Liu, Senior Director of Pan Am Clinical Operations, Teva Neuroscience Identifier: NCT00240006     History of Changes
Other Study ID Numbers: PM024
Study First Received: October 13, 2005
Last Updated: April 8, 2011

Keywords provided by Teva Pharmaceutical Industries:
Multiple Sclerosis
Shared Solutions®

Additional relevant MeSH terms:
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 processed this record on September 21, 2017