Monitoring the safety of Rinvoq™ (upadacitinib) in patients
Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)
This study is trying to see how safe Rinvoq™ is for people with inflammatory diseases like rheumatoid arthritis and psoriatic arthritis after they start taking it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidade do Porto Academic / other |
| Drugs / interventions | upadacitinib |
| Locations | 3 sites (Porto and 2 other locations) |
| Trial ID | NCT06498167 on ClinicalTrials.gov |
What this trial studies
The LOOK-UP study is an observational clinical study aimed at monitoring the post-marketing safety of Rinvoq™ (upadacitinib), a medication used for treating various inflammatory diseases such as rheumatoid arthritis and psoriatic arthritis. Conducted by the Porto Pharmacovigilance Centre and coordinated by INFARMED, the study focuses on quantifying the incidence of serious adverse events in patients prescribed Rinvoq™. It also aims to analyze adverse events among specific patient subgroups and characterize patient-reported outcomes. The study is essential for ensuring ongoing safety surveillance in real-world settings following the drug's approval.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been prescribed Rinvoq™ starting from January 1, 2024.
Not a fit: Patients with cognitive impairments that prevent them from responding to questionnaires or those with a life expectancy of less than one month may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of Rinvoq™'s safety profile, leading to better patient management and outcomes.
How similar studies have performed: Other studies monitoring post-marketing safety of medications have shown success in identifying adverse events, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Porto and 2 other locations
- Unidade Local de Saúde de Santo António, E.P.E. — Porto, Portugal (Active_not_recruiting)
- Unidade Local de Saúde de São João, E.P.E. — Porto, Portugal (Recruiting)
- Unidade Local de Saúde de Gaia/Espinho, E.P.E. — Porto, Portugal (Active_not_recruiting)
Study contacts
- Principal investigator: Inês Ribeiro Vaz, PharmD, MPH, PhD — Universidade do Porto
- Study coordinator: Inês Ribeiro Vaz, PharmD, MPH, PhD
- Email: inesvaz@med.up.pt
- Phone: + 351220426952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.