An Active Surveillance Study to Monitor the Safety of Abrocitinib Among Real-World Patients with Atopic Dermatitis (AD) in the European Union (EU)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000282
• EU PAS number:
  EUPAS1000000282
• Study ID:
  1000000282
• Official title and acronym:
  An Active Surveillance Study to Monitor the Safety of Abrocitinib Among Real-World Patients with Atopic Dermatitis (AD) in the European Union (EU)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Sweden
• Study description:
  The primary objective of the study is to estimate the IRs of the safety events of interest among patients with AD receiving abrocitinib and patients with AD receiving biologic and/or non biologic (non-JAKi) chronic systemic treatments for AD (herein referred to as “comparator treatments”) in a real-world setting. ; The following are the safety events of interest for this study:; • VTE; • HZ; • Serious infections and opportunistic infections; • Rhabdomyolysis; • GI perforation; • MACE; • Fractures; • Malignancy excluding NMSC; • NMSC; • All-cause mortality ; • Height as a measure of impaired bone growth in adolescents (Denmark only).; ; This will be a longitudinal, register-based, non-interventional post-authorisation safety cohort study using routinely collected (secondary) population-based data.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Bordeaux PharmacoEpi, University of Bordeaux

France

Pfizer

Networks

The SIGMA Consortium (SIGMA)

Denmark

European Union

France

Germany

Italy

Netherlands

Norway

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 22/06/2022

Actual: 22/06/2022

Study start date

Planned: 31/12/2024

Actual: 31/12/2024

Data analysis start date

Planned: 16/05/2034

Date of interim report, if expected

Planned: 15/11/2029

Date of final study report

Planned: 15/11/2034

Sources of funding

Pharmaceutical company and other private sector 

Study protocol

Updated protocol

B7451084_ABROCITINIB PROTOCOL AMENDMENT 1_23MAY2024.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

B7451084