Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498167
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-04
Brief Title:
Active Pharmacovigilance Study of the Medicine Rinvoq Upadacitinib
Sponsor:
Universidade do Porto
Organization:
Universidade do Porto
Study Overview
Official Title:
Active Pharmacovigilance Study of the Medicine Rinvoq Upadacitinib
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOOK-UP
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 Crohns 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 IP 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 Crohns 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUPAS1000000227 | OTHER | None | None |