RecruitingNCT06498167

Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

Sponsor

Universidade do Porto

Enrollment

150 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Adverse Drug Event Drug Use Drug Side Effect Inflammatory Disease Safety Issues Adverse Drug Reaction

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Prescription of Rinvoq™ from January 1, 2024;
years of age or older at the time of recruitment; and
Expressed consent to participate in the study.

Exclusion Criteria4

They have any degree of cognitive impairment that prevents them from responding to a questionnaire administered by telephone;
They are participating in a phase I, II, or III clinical trial;
They have a life expectancy of less than 1 month; or
They do not have a valid telephone contact.

Interventions

DRUGUpadacitinib

Exposure to upadacitinib (Rinvoq™) in its different formulations approved by the Portuguese regulatory authority (15, 30, or 45mg extended-release tablets).