Study identification

PURI

https://redirect.ema.europa.eu/resource/47968

EU PAS number

EUPAS39217

Study ID

47968

Official title and acronym

Long-term comparative safety cohort studies of upadacitinib (Rinvoq™) use for the treatment of RA in Europe

DARWIN EU® study

No

Study countries

Denmark
Germany
Spain
Sweden
United Kingdom (Northern Ireland)

Study description

The purpose of this study is to evaluate and characterise the important identified and potential risks of upadacitinib (Rinvoq™) and missing information on the safety of upadacitinib, as described in the European Union (EU) Risk Management Plan (RMP) for Rinvoq™ (upadacitinib). This study aims to evaluate the long-term safety of upadacitinib among patients with RA receiving routine clinical care.

Study status

Ongoing
Research institution and networks

Institutions

Contact details

Clinical Trial 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

p19150-protocol abstract-pmos_Redacted

English (218.99 KB - PDF)View document
Updated protocol

P19150-protocol-pmos-v3-Abstract_Redacted

English (279.11 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)