Ignite Creation Date:
2024-07-17 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469424
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-07
Brief Title:
An Active Surveillance Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research UR-CARE in the European Union EU
Sponsor:
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Organization:
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Study Overview
Official Title:
An Active Surveillance Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research UR-CARE in the European Union EU
Status:
RECRUITING
Status Verified Date:
2024-06
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:
PASS TOFA
Brief Summary:
The purpose of this study is to estimate the incidence rates of malignancy excluding non-melanoma skin cancer NMSC venous thromboembolic events VTE deep venous thrombosis DVT and pulmonary embolism PE NMSC major adverse cardiac events MACE progressive multifocal leukoencephalopathy PML infections hospitalization and specific antibiotic or antiviral treatment lung cancer lymphoma herpes zoster myocardial infarction MI gastrointestinal GI perforations fractures surgery for UC and death through 4 sub-groups adult patients with UC who initiate tofacitinib in the course of routine clinical care compared to other medications approved to treat UC
Detailed Description:
Rationale and background
Tofacitinib an inhibitor of the Janus kinase JAK family of kinases was approved in the European Union EU in July 2018 at a dose of 5 mg twice daily or 10 mg twice daily for the treatment of adults with moderate-to-severe ulcerative colitis UC who have had an inadequate response lost response or were intolerant to either conventional therapy or a biologic agent Malignancy excluding non-melanoma skin cancer NMSC is an important potential risk and venous thromboembolism VTE is an important identified risk associated with the use of tofacitinib and follow-up of large cohorts of patients over a long period is needed to evaluate the risks of these safety events as well as other potential safety events of interest that may be associated with tofacitinib treatment Pfizer will implement a post approval active surveillance study of tofacitinib exposed and unexposed patients using actively collected prospective data included in the UR-CARE platform
Research question
What are the incidence rates of safety events of interest in adult patients with UC treated with tofacitinib in routine clinical care as compared to the incidence rates in patients with UC treated with other approved systemic agents and patients with UC naïve to biologics and immunomodulatorsimmunosuppressants hereafter referred to as immunosuppressants
Study design
This is an active cohort study of adult patients with UC aged 18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment The study will use secondary data collected in the UR-CARE platform which is an ongoing prospective observational cohort of European Union EU patients with inflammatory bowel disease IBD with the primary aim of facilitating daily patient care and research studies in IBD This study will focus only on patients with UC enrolled in the UR-CARE platform
Variables
The study variables include baseline patient characteristics ie clinical and demographic characteristics comorbidities and current and past therapies the primary outcomes of interest and other safety events of interest
Data sourcesUR-CARE will be used as the only data source
Study size
This study is descriptive and all eligible patients in UR-CARE registry during the study period who have consented to participate in the study will be included with no upper limit on the sample size
Data analysis
All statistical analysis will be performed by GETECCU using SAS software v94 SAS Institute Inc Cary NC USA Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan SAP
Tofacitinib an inhibitor of the Janus kinase JAK family of kinases was approved in the European Union EU in July 2018 at a dose of 5 mg twice daily or 10 mg twice daily for the treatment of adults with moderate-to-severe ulcerative colitis UC who have had an inadequate response lost response or were intolerant to either conventional therapy or a biologic agent Malignancy excluding non-melanoma skin cancer NMSC is an important potential risk and venous thromboembolism VTE is an important identified risk associated with the use of tofacitinib and follow-up of large cohorts of patients over a long period is needed to evaluate the risks of these safety events as well as other potential safety events of interest that may be associated with tofacitinib treatment Pfizer will implement a post approval active surveillance study of tofacitinib exposed and unexposed patients using actively collected prospective data included in the UR-CARE platform
Research question
What are the incidence rates of safety events of interest in adult patients with UC treated with tofacitinib in routine clinical care as compared to the incidence rates in patients with UC treated with other approved systemic agents and patients with UC naïve to biologics and immunomodulatorsimmunosuppressants hereafter referred to as immunosuppressants
Study design
This is an active cohort study of adult patients with UC aged 18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment The study will use secondary data collected in the UR-CARE platform which is an ongoing prospective observational cohort of European Union EU patients with inflammatory bowel disease IBD with the primary aim of facilitating daily patient care and research studies in IBD This study will focus only on patients with UC enrolled in the UR-CARE platform
Variables
The study variables include baseline patient characteristics ie clinical and demographic characteristics comorbidities and current and past therapies the primary outcomes of interest and other safety events of interest
Data sourcesUR-CARE will be used as the only data source
Study size
This study is descriptive and all eligible patients in UR-CARE registry during the study period who have consented to participate in the study will be included with no upper limit on the sample size
Data analysis
All statistical analysis will be performed by GETECCU using SAS software v94 SAS Institute Inc Cary NC USA Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan SAP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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