A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Sweden Using the SRQ Register

Study identification

• EU PAS number:
  EUPAS31529
• Study ID:
  32093
• Official title and acronym:
  A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Sweden Using the SRQ Register
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  An expansion of ongoing post-marketing monitoring of abatacept to include all patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept with a specific look at select malignancies outcomes.
• Study status:
  Finalised

Research institutions and networks

Institutions

Karolinska Institutet

Sweden

Study timelines

Date when funding contract was signed

Actual:21/06/2019

Study start date

Planned:01/10/2019

Actual:01/10/2019

Date of final study report

Planned:31/05/2025

Actual:22/08/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

BMS IM101-816