Study identification

PURI

https://redirect.ema.europa.eu/resource/47974

EU PAS number

EUPAS39211

Study ID

47974

Official title and acronym

Drug utilisation study of upadacitinib (Rinvoq™) in Europe to evaluate the effectiveness of additional risk minimisation measures

DARWIN EU® study

No

Study countries

Denmark
Germany
Spain
Sweden
United Kingdom (Northern Ireland)

Study description

This study aims to characterise the use of upadacitinib (Rinvoq™) in routine clinical care, including describing baseline characteristics of individuals with rheumatoid arthritis exposed to upadacitinib relative to individuals with rheumatoid arthritis exposed to other systemic treatments. This study also aims to evaluate the effectiveness of additional risk minimisation measures.

Study status

Ongoing
Research institution and networks

Institutions

Contact details

Clinical Trial Disclosure AbbVie

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AbbVie
Study protocol
Initial protocol

p20199-protocol abstract-pmos_Redacted

English (183.53 KB - PDF)View document
Updated protocol

P20-199_Protocol v2.0_Abstract_Redacted

English (155.12 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)