A Post-marketing Study to Assess the Safety of Abatacept in Sweden Using the Swedish Rheumatology Quality Register (SRQ) Register

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Psoriatic Arthritis; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT05413044

IM101-816

Details and patient eligibility

About

The purpose of this study is to collect real-world data in order to estimate the frequency of overall malignancies, melanoma, basal cell carcinoma, and squamous cell carcinoma in participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) enrolled in the SRQ Register in Sweden.

Enrollment: 4,300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of RA or PsA
• ≥18 years at index treatment initiation
• Participants starting treatment with:
• abatacept
• non-targeted DMARDs
• targeted DMARD

Exclusion criteria

• Not applicable

Trial design

4,300 participants in 3 patient groups

Abatacept Group

Description:

Participants with established RA or 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 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.