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

Study identification

• 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

Porto Pharmacovigilance Centre, Faculty of Medicine, University of Porto (UFPorto)

Portugal

Medicines Risk Management Department, Infarmed

Portugal

Study timelines

Date when funding contract was signed

Planned:01/03/2024

Study start date

Planned:31/03/2024

Actual:31/03/2024

Data analysis start date

Planned:01/11/2024

Date of interim report, if expected

Planned:31/12/2024

Actual:31/12/2024

Date of final study report

Planned:28/02/2025

Actual:28/02/2025

Sources of funding

National competent authority (NCAs)

More details on funding

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

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable