A post-marketing registry-based prospective cohort study of long-term safety of risankizumab in Denmark and Sweden

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48467
• EU PAS number:
  EUPAS39351
• Study ID:
  48467
• Official title and acronym:
  A post-marketing registry-based prospective cohort study of long-term safety of risankizumab in Denmark and Sweden
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Sweden
• Study description:
  The aim of the study is to estimate the risk of malignancy, MACE, serious infections, serious hypersensitivity reactions and incident hepatitis B and C among individuals with psoriasis who were exposed to risankizumab, relative to individuals with psoriasis exposed to other systemic treatments (biologics and non-biologics) divided into three subgroups, other IL-inhibitors treatment (excluding risankizumab), TNF-α inhibitor treatment, and non-biologic systemic treatment.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

The Danish National University Hospital Denmark

Study timelines

Date when funding contract was signed

Planned: 29/09/2020

Actual: 29/09/2020

Study start date

Planned: 31/12/2021

Actual: 07/02/2022

Date of final study report

Planned: 31/12/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Study protocol

Initial protocol

p19633-protocol abstract-pmos-04sep2020_Redacted

Updated protocol

p19633-protocol-V1.6_Abstract_Redacted

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

P19-633