Rheumatoid Arthritis Clinical Trial
Official title:
Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients Treated With Biologic Disease Modifying Antirheumatic Drug (DMARD) Therapies
Verified date | September 2010 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: No Health Authority |
Study type | Observational |
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)
Status | Completed |
Enrollment | 3940 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. Inclusion Criteria: - 18 to 64 years of age at index date - Diagnosis of RA during the study period (ICD-9CM 714.xx) - Evidence of at least one biologic DMARD of interest during the study timeframe - Continuous enrollment during the study timeframe - Both medical and pharmacy benefits - No evidence of a claim for a bDMARD in the 6-month pre-period Exclusion Criteria: - 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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of patient cost share on discontinuation | Assessed from first prescription date and followed for 1-year | No | |
Secondary | RA-related healthcare utilization and costs | Pre-index: 6-month period prior to the index drug date | No | |
Secondary | All-cause healthcare utilization and costs | Pre-index: 6-month period prior to the index drug date | No | |
Secondary | RA-related healthcare utilization and costs | Post-period: Index date+365 days | No | |
Secondary | All-cause healthcare utilization and costs | Post-period: Index date+365 days | No |
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