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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

Tracking Information
First Submitted Date  ICMJE October 13, 2005
First Posted Date  ICMJE October 17, 2005
Last Update Posted Date April 11, 2011
Study Start Date  ICMJE January 2006
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
Adherence rate of Copaxone therapy by procedural intervention [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00240006 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone
Official Title  ICMJE 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
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®.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Procedure: Shared Solutions® plus MS Center v. Shared Solutions®
Copaxone
Study Arms  ICMJE
  • Experimental: 1
    Shared Solutions®
    Intervention: Procedure: Shared Solutions® plus MS Center v. Shared Solutions®
  • Experimental: 2
    Shared Solutions® and MS Center/Office Practice Partnership
    Intervention: Procedure: Shared Solutions® plus MS Center v. Shared Solutions®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2008)
307
Original Enrollment  ICMJE
 (submitted: October 13, 2005)
340
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00240006
Other Study ID Numbers  ICMJE PM024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Siyu Liu, Senior Director of Pan Am Clinical Operations, Teva Neuroscience
Study Sponsor  ICMJE Teva Neuroscience, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MerriKay Oleen-Burkey, Ph.D. Teva Neuroscience, Inc.
PRS Account Teva Pharmaceutical Industries
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP