Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000151

EU PAS number

EUPAS1000000151

Study ID

1000000151

Official title and acronym

Comparative Cohort Study of Long-term Safety Outcomes of Risankizumab Compared to Biologic Treatments for Crohn’s Disease in a Real-world Setting in Sweden and Denmark

DARWIN EU® study

No

Study countries

Denmark
Sweden

Study description

The objective is to estimate and compare, where possible, the incidence rates of malignancy excluding non-melanoma skin cancer, non-melanoma skin cancer, serious infections (including opportunistic infections), serious hypersensitivity reactions and major adverse cardiovascular events, among individuals with moderate to severe Crohn’s disease aged ≥18 years who initiate risankizumab in the course of routine clinical care, as well as the incidence rates in individuals who initiate other approved biologic comparator treatments for the treatment of Crohn’s disease.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Johan Reutfors

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AbbVie
Study protocol
Initial protocol

P23654_Risa_CD-Study_abstract_Redacted.pdf

English (135.76 KB - PDF)View document
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)