Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000227

EU PAS number

EUPAS1000000227

Study ID

1000000227

Official title and acronym

LOOK-UP: Active pharmacovigilance study of the medicine Rinvoq™ (upadacitinib)

DARWIN EU® study

No

Study countries

Portugal

Study description

The LOOK-UP is an investigator-initiated clinical study with the aim of monitoring the post-marketing safety of the medicine Rinvoq™ (upadacitinib), which is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease.
The Marketing Authorisation Holder is AbbVie Deutschland GmbH & Co. KG.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Inês Ribeiro Vaz

Primary lead investigator
ORCID number:
0000-0002-3442-8158
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
National competent authority (NCAs)

More details on funding

INFARMED - Portuguese Authority of Medicines and Health Products, I.P.
Study protocol
Initial protocol

StudyProtocol_31.06.2024.pdf

English (314.53 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable