A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database

Bristol-Myers Squibb38,396 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

38,396

Conditions

Rheumatoid Arthritis (RA)Psoriatic Arthritis (PsA)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution - 0001

Lawrenceville, New Jersey, United States

Outcomes

Primary Outcomes

Incidence Rates of Overall Malignancies

Time frame: Up to 5 years

Incidence Rates of Melanoma

Time frame: Up to 5 years

Incidence Rates of Non-melanoma Skin Cancer

Time frame: Up to 5 years

Incidence Rates of Basal Cell Carcinoma

Time frame: Up to 5 years

Incidence Rates of Squamous Cell Carcinoma

Time frame: Up to 5 years

Data from ClinicalTrials.gov

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