Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-29 @ 11:39 AM
Study NCT ID:
NCT00240006
Status:
COMPLETED
Last Update Posted:
2011-04-11
First Post:
2005-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-08', 'studyFirstSubmitDate': '2005-10-13', 'studyFirstSubmitQcDate': '2005-10-13', 'lastUpdatePostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence rate of Copaxone therapy by procedural intervention', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Copaxone®', 'Shared Solutions®'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or females, 18 years of age or older.\n2. Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted).\n3. Beginning or restarting therapy with Glatiramer Acetate (Copaxone®).\n4. Willing and able to complete all procedures and evaluations related to the study.\n5. Willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®.\n2. 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.\n3. Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.\n4. Pregnant or trying to become pregnant, or breast feeding during the study.\n5. Previously participated in this study or another clinical research study in the past 30 days."}, 'identificationModule': {'nctId': 'NCT00240006', 'briefTitle': 'A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PM024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Shared Solutions®', 'interventionNames': ['Procedure: Shared Solutions® plus MS Center v. Shared Solutions®']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Shared Solutions® and MS Center/Office Practice Partnership', 'interventionNames': ['Procedure: Shared Solutions® plus MS Center v. Shared Solutions®']}], 'interventions': [{'name': 'Shared Solutions® plus MS Center v. Shared Solutions®', 'type': 'PROCEDURE', 'description': 'Copaxone', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MerriKay Oleen-Burkey, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Neuroscience, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Neuroscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Siyu Liu, Senior Director of Pan Am Clinical Operations', 'oldOrganization': 'Teva Neuroscience'}}}}