Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107125
• EU PAS number:
  EUPAS107124
• Study ID:
  107125
• Official title and acronym:
  Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Spain

  Sweden
• Study description:
  This study aims to evaluate the long-term safety of upadacitinib use in adults in routine clinical care for the treatment of Ulcerative Colitis (UC) and Crohn's Disease (CD) Main objectives are to describe and compare the incidence of gastrointestinal (GI) perforation, and where possible, the incidence of fractures and drug-induced liver injury (DILI), in adults with UC or CD treated with upadacitinib, relative to those treated with select biologic inflammatory bowel disease (IBD) treatments at a similar line of therapy. To describe and compare, where possible, the incidence of the secondary safety outcomes, malignancy excluding non-melanoma skin cancer (NMSC), stratified by type, NMSC, major adverse cardiovascular events, venous thromboembolic event, serious infections (defined as all infections that require hospitalization, including opportunistic infections), herpes zoster, active tuberculosis, all-cause mortality, in adults with UC or CD treated with upadacitinib, relative to those treated with select biologic IBD treatments at a similar line of therapy.
• Study status:
  Ongoing

Research institution and networks

Institutions

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Study timelines

Date when funding contract was signed

Actual: 25/08/2022

Study start date

Planned: 10/11/2023

Actual: 10/11/2023

Date of interim report, if expected

Planned: 31/12/2029

Date of final study report

Planned: 30/06/2035

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Study protocol

Initial protocol

p24343-protocol-pmos-v1.0_Redacted 2.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

P24-343