Clinical trial NCT06498167: Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)
Official title: Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Disease
Drug Side Effect
Drug Use
Adverse Drug Event
Adverse Drug Reaction
Safety Issues
Keywords: Upadacitinib
Rinvoq
Rheumatoid arthritis
Psoriatic arthritis
Axial spondyloarthritis
Atopic dermatitis
Ulcerative colitis
Crohn's disease
Pharmacovigilance risk
Drug safety monitoring
Patient Safety
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
name: Unidade de Farmacovigilância do Porto
name: Unidade Local de Saúde de São João, E.P.E.
name: Unidade Local de Saúde de Santo António, E.P.E.
name: Unidade Local de Saude de Gaia e Espinho EPE
name: RISE Health
First posted: 2024-07-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients exposed to upadacitinib (Rinvoq™).

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™.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: For the prospective cohort, the follow-up includes contacts at baseline (t=0), 2 weeks (t=1), 1 month (t=2), 2 months (t=3), and 3 months (t=4) after starting treatment.
Secondary outcomes:
measure: Rate of non-compliance with PRAC recommendations
timeFrame: This outcome will be assessed at any time during the three-month monitoring period of each patient.
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Unidade Local de Saúde de Santo António, E.P.E.
city: Porto
country: Portugal
facility: Unidade Local de Saúde de São João, E.P.E.
city: Porto
country: Portugal
facility: Unidade Local de Saúde de Gaia/Espinho, E.P.E.
Study officials:
affiliation: Universidade do Porto
name: Inês Ribeiro Vaz, PharmD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: