Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Portugal
Unidade Local de Saúde de Gaia/Espinho, E.P.E.
ACTIVE_NOT_RECRUITING
Porto
Unidade Local de Saúde de Santo António, E.P.E.
ACTIVE_NOT_RECRUITING
Porto
Unidade Local de Saúde de São João, E.P.E.
RECRUITING
Porto
Contact Information
Primary
Inês Ribeiro Vaz, PharmD, MPH, PhD
inesvaz@med.up.pt
+ 351220426952
Backup
Renato Ferreira da Silva, PharmD
rsilva@med.up.pt
+351220426913
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 150
Treatments
Upadatacinib Arm
Patients exposed to upadacitinib (Rinvoq™)
Related Therapeutic Areas
Sponsors
Collaborators: RISE Health, INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., Unidade Local de Saúde de São João, E.P.E., Unidade de Farmacovigilância do Porto, Unidade Local de Saude de Gaia e Espinho EPE, Unidade Local de Saúde de Santo António, E.P.E.
Leads: Universidade do Porto