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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Rheumatoid Arthritis (RA); Psoriatic Arthritis (PsA)

Study type: Observational

Funder types: Industry

Identifiers

NCT05421442

EUPAS31532 (Registry Identifier)

IM101-803

Details and patient eligibility

About

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).

Enrollment: 38,396 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38,396 participants in 3 patient groups

Abatacept Group

Description:

Participants with established rheumatoid arthritis (RA) or psoriatic arthritis (PsA) and receiving abatacept

Non-targeted Disease Modifying Anti-rheumatic Drug (DMARD) Group

Description:

Participants with established RA or PsA and not previously treated with any targeted disease modifying anti-rheumatic drugs (DMARDs) and who start treatment with a non-targeted DMARD

Targeted DMARD Group

Description:

Participants with established RA or PsA and previously treated without abatacept who start treatment with targeted DMARDs