A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone
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
1 other identifier
interventional
307
0 countries
N/A
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 multiple-sclerosis
Started Jan 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2005
CompletedFirst Posted
Study publicly available on registry
October 17, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedApril 11, 2011
April 1, 2011
1 year
October 13, 2005
April 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence rate of Copaxone therapy by procedural intervention
90 days
Secondary Outcomes (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
90 days
Study Arms (2)
1
EXPERIMENTALShared Solutions®
2
EXPERIMENTALShared Solutions® and MS Center/Office Practice Partnership
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MerriKay Oleen-Burkey, Ph.D.
Teva Neuroscience, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 13, 2005
First Posted
October 17, 2005
Study Start
January 1, 2006
Primary Completion
January 1, 2007
Study Completion
September 1, 2007
Last Updated
April 11, 2011
Record last verified: 2011-04