Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT01137851
Status:
COMPLETED
Last Update Posted:
2010-10-01
First Post:
2010-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3940}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-30', 'studyFirstSubmitDate': '2010-06-03', 'studyFirstSubmitQcDate': '2010-06-04', 'lastUpdatePostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of patient cost share on discontinuation', 'timeFrame': 'Assessed from first prescription date and followed for 1-year'}], 'secondaryOutcomes': [{'measure': 'RA-related healthcare utilization and costs', 'timeFrame': 'Pre-index: 6-month period prior to the index drug date'}, {'measure': 'All-cause healthcare utilization and costs', 'timeFrame': 'Pre-index: 6-month period prior to the index drug date'}, {'measure': 'RA-related healthcare utilization and costs', 'timeFrame': 'Post-period: Index date+365 days'}, {'measure': 'All-cause healthcare utilization and costs', 'timeFrame': 'Post-period: Index date+365 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/home.aspx', 'label': 'BMS Clinical Trials Disclosure'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Commercial health plan members', 'healthyVolunteers': False, 'eligibilityCriteria': "Patients diagnosed with Rheumatoid Arthritis (RA) who newly initiated a biologic DMARD (bDMARD) during a study timeframe of 1/01/06 to 3/31/09.\n\nInclusion Criteria:\n\n* 18 to 64 years of age at index date\n* Diagnosis of RA during the study period (ICD-9CM 714.xx)\n* Evidence of at least one biologic DMARD of interest during the study timeframe\n* Continuous enrollment during the study timeframe\n* Both medical and pharmacy benefits\n* No evidence of a claim for a bDMARD in the 6-month pre-period\n\nExclusion Criteria:\n\n* Patients are excluded if they have a diagnosis of psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis at any time during the study timeframe; have a claim for Rituxan, IV etanercept, or IV adalimumab; or have Medicare or Medicaid during the study timeframe"}, 'identificationModule': {'nctId': 'NCT01137851', 'briefTitle': 'Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients Treated With Biologic Disease Modifying Antirheumatic Drug (DMARD) Therapies', 'orgStudyIdInfo': {'id': 'IM101-256'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'New to bDMARD', 'description': 'New to bDMARD RA patients with high and low cost share who continue or discontinue treatment'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}