A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone
This study has been completed.
Sponsor:
Teva Neuroscience, Inc.
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00240006
First received: October 13, 2005
Last updated: April 8, 2011
Last verified: April 2011
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
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:
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240006
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:
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 Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases |
Immune System Diseases Nervous System Diseases Pharmaceutical Solutions Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015