A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32096
• EU PAS number:
  EUPAS31532
• Study ID:
  32096
• Official title and acronym:
  A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  An expansion of ongoing post-marketing monitoring of abatacept to include all patients with RA and PsA treated with abatacept with a specific look at select malignancies outcomes.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Aalborg University Hospital

Clinical for Internal and Emerg Medicine,The North Denmark Region

Study timelines

Date when funding contract was signed

Actual: 13/06/2019

Study start date

Planned: 01/10/2019

Actual: 01/10/2019

Date of final study report

Planned: 01/05/2025

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 IM101-803