A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database
Active, not recruiting
- Conditions
- Rheumatoid Arthritis (RA)Psoriatic Arthritis (PsA)
- Registration Number
- NCT05421442
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to expand on the ongoing post-marketing monitoring of abatacept to include all participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept captured in Danish Database for Biologic Therapies (DANBIO).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1450
Inclusion Criteria
- Diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA)
- Receiving treatment with abatacept
- Receiving treatment with non-targeted DMARD
- Receiving treatment with targeted DMARD
Exclusion Criteria
-Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence Rates of Non-melanoma Skin Cancer Up to 5 years Incidence Rates of Overall Malignancies Up to 5 years Incidence Rates of Basal Cell Carcinoma Up to 5 years Incidence Rates of Squamous Cell Carcinoma Up to 5 years Incidence Rates of Melanoma Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution
🇺🇸Princeton, New Jersey, United States