NCT00240006CompletedPhase 4
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
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Teva Neuroscience, Inc.
- Enrollment
- 307
- Primary Endpoint
- Adherence rate of Copaxone therapy by procedural intervention
Study Overview
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®.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Adherence rate of Copaxone therapy by procedural intervention
Time Frame: 90 days
Secondary Outcomes
- 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)
Investigators
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