Active Pharmacovigilance Study of the Medicine Rinvoq14 (Upadacitinib) Monitoring Safety in Inflammatory Diseases

What this Trial Is About

Researchers are monitoring the safety of the medicine Rinvoq14 (upadacitinib), which is used to treat several inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. This observational Phase 4 study is led by the University of Porto and conducted in hospital settings to gather real-world data on adverse effects after the medicine was approved and placed under additional monitoring by the European Medicines Agency. The study observes patients who have been prescribed Rinvoq14, tracking their experiences without altering their treatment. It includes both prospective and retrospective monitoring, with contacts scheduled at the start of treatment and at multiple points over three months. Researchers focus on identifying serious adverse events such as cancers, cardiovascular problems, infections, liver injuries, and bone fractures. They also assess how well patients follow safety recommendations issued for the medicine's use. Participants will be contacted at baseline, 2 weeks, 1 month, 2 months, and 3 months after starting Rinvoq14 to report any adverse events and to check compliance with safety measures. The study collects detailed patient information through questionnaires administered by telephone. This ongoing monitoring aims to better understand the risks and safety profile of Rinvoq14 in real-world use, with all data collected in the Porto district hospitals from 2024 onwards.

Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)