Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversidade do Porto

About this trial

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 criteria

Qualifiers

Prescription of Rinvoq™ from January 1, 2024;

18 years of age or older at the time of recruitment; and

Expressed consent to participate in the study.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Upadacitinib

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators

Universidade do Porto

Lead sponsor

INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.

Collaborator

Unidade de Farmacovigilância do Porto

Collaborator

Unidade Local de Saúde São João

Collaborator

Unidade Local de Saúde de Santo António, E.P.E.

Collaborator

Unidade Local de Saude de Gaia e Espinho EPE

Collaborator

RISE Health

Collaborator