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)
NCT ID: NCT06469424
Last Updated: 2024-06-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
104 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-01-11
Study Completion Date
2026-03-31
Brief Summary
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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.
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Detailed Description
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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 immunomodulators/immunosuppressants (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 (i.e., clinical and demographic characteristics, comorbidities, and current and past therapies), the primary outcomes of interest, and other safety events of interest.
Data sources:UR-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 v9.4, 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 immunomodulators/immunosuppressants (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 (i.e., clinical and demographic characteristics, comorbidities, and current and past therapies), the primary outcomes of interest, and other safety events of interest.
Data sources:UR-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 v9.4, 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).
Conditions
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Ulcerative Colitis
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Cohort 1 (Tofacitinib cohort):
Initiation of tofacitinib (i.e., first ever prescription) from 01 July 2018 through to 31 March 2025
No interventions assigned to this group
Cohort 2 (Biologics cohort):
* Initiation (i.e., first ever prescription) of a specific biologic agent (any TNFi or non-TNFi agent) from 01 July 2018 through to 31 March 2025
* No prior use of specific biologic agent prior to index date using all available data
No interventions assigned to this group
Cohort 3 (Immunosuppressants cohort):
* Initiation (i.e., first ever prescription) of a specific immunosuppressant agent (without concurrent biologic therapy) from 01 July 2018 through to 31 March 2025
* No prior use of specific immunosuppressant prior to index date using all available data
No interventions assigned to this group
Cohort 4 (Naïve cohort):
* Patients diagnosed with UC since 01 July 2018 through to 31 March 2025
* Patients with no history of surgery for UC (surgery suggests more severe disease, and such patients would not be representative of patients with generally mild disease in Cohort 4)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Adult patients aged ≥18 years,
* With Ulcerative colitis diagnosis per ECCO guidelines,
* Enrolled in UR-CARE registry with 12 months of medical history available in UR-CARE prior to the index date,
* With an informed consent signed. A minimum follow-up duration of 12 months will allow evaluation of safety events of interest.
* Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date \[i.e. date of first prescription for tofacitinib\].
* With Ulcerative colitis diagnosis per ECCO guidelines,
* Enrolled in UR-CARE registry with 12 months of medical history available in UR-CARE prior to the index date,
* With an informed consent signed. A minimum follow-up duration of 12 months will allow evaluation of safety events of interest.
* Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date \[i.e. date of first prescription for tofacitinib\].
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Pfizer
INDUSTRY
Sponsor Role
collaborator
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Manuel MD Barreiro, PhD
Role: PRINCIPAL_INVESTIGATOR
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Locations
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Imelda General Hospital
Bonheiden, , Belgium
Site Status
RECRUITING
AZ Delta vzw
Roeselare, , Belgium
Site Status
RECRUITING
Acibadem City Clinic Tokuda University Hospital
Sofia, , Bulgaria
Site Status
RECRUITING
General Hospital of Athens "Evangelismos"
Ellinikó, Attica, Greece
Site Status
RECRUITING
Lithuanian University of Life Sciences
Kaunas, , Lithuania
Site Status
NOT_YET_RECRUITING
Countries
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Belgium
Bulgaria
Greece
Lithuania
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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PASS TOFA
Identifier Type: -
Identifier Source: org_study_id
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