Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2025-12-25 @ 12:29 AM
NCT ID:
NCT06498167
Brief Summary:
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.
Detailed Description:
The LOOK-UP study is an investigator-initiated clinical study conducted by INFARMED, the Portuguese Authority of Medicines and Health Products, I.P., and coordinated by the Porto Pharmacovigilance Centre at the Faculty of Medicine, University of Porto. The study aims to monitor the post-marketing safety of Rinvoq™ (upadacitinib), a medicine indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. Rinvoq™, a selective and reversible Janus Kinase (JAK) 1 inhibitor, has been under additional monitoring by the European Medicines Agency (EMA) since its approval in December 2019, necessitating active safety surveillance in real-world settings.
The primary objective of the LOOK-UP study is to quantify the incidence of adverse events in patients prescribed Rinvoq™, with a focus on serious adverse events such as malignant neoplasms, non-melanoma skin cancer, major adverse cardiovascular events, venous thromboembolism, serious and opportunistic infections, gastrointestinal perforations, liver injuries, bone fractures, and all-cause mortality. Secondary objectives include describing the incidence of adverse events among specific subgroups, such as very elderly patients, patients with moderate hepatic impairment, and patients with severe renal impairment. Additionally, the study aims to characterize patient-reported adverse events using MedDRA terms. An exploratory objective is to evaluate adherence to risk minimization measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) for the safe use of Rinvoq™.
The study is designed as a Phase 4 post-authorization safety study (PASS), utilizing an observational cohort approach that is both multicentric and ambispective. This design includes prospective and retrospective monitoring of patients, ensuring comprehensive safety analysis. The study will be conducted exclusively in hospital settings within the Porto district, reflecting the prescription and usage constraints of Rinvoq™.
Study:
NCT06498167
Study Brief:
Protocol Section:
NCT06498167