Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

Recruiting

• Conditions: Drug Side Effect; Drug Use; Inflammatory Disease; Adverse Drug Reaction; Safety Issues; Adverse Drug Event
• Interventions: Drug: Upadacitinib

• Registration Number: NCT06498167
• Lead Sponsor: Universidade do Porto

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™.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-12
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Upadatacinib Arm	Upadacitinib	Patients exposed to upadacitinib (Rinvoq™)

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	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.	Incidence of adverse events occurring during the established follow-up period, coded according to MedDRA terminology.; The outcome will be assessed through an ad-hoc questionnaire. The occurrence of adverse events will be queried in an open-ended, non-directed manner. Patients will be encouraged to report any undesired events they experience during the treatment, without being limited to predefined specific adverse events.

Secondary Outcome Measures

Name	Time	Method
Rate of non-compliance with PRAC recommendations	This outcome will be assessed at any time during the three-month monitoring period of each patient.	Rate at which patients identified with risk factors are prescribed Rinvoq™ despite the availability of viable therapeutic alternatives. Patients considered to have risk factors include: (i) individuals aged 65 or older; (ii) current smokers or those with a long history of smoking; (iii) individuals at high risk of serious cardiovascular problems, such as heart attacks or strokes, or those more likely to develop cancer.; The outcome will be assessed through direct contact with clinical specialists (prescribers) to confirm the availability of therapeutic alternatives. A case is non-compliant if a patient with risk factors is prescribed Rinvoq™ despite an available alternative.

Trial Locations

Locations (3)

Unidade Local de Saúde de São João, E.P.E.; 🇵🇹 Porto, Portugal

Unidade Local de Saúde de Santo António, E.P.E.; 🇵🇹 Porto, Portugal

Unidade Local de Saúde de Gaia/Espinho, E.P.E.; 🇵🇹 Porto, Portugal