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)

NCT06469424 | Recruiting DMC

• 1 other identifier: PASS TOFA
• Study Type: observational
• Target: 104
• Locations: 4 countries
• Sites: 5

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.

Conditions

Ulcerative Colitis

Keywords

prospective observational study with medication

Outcome Measures

Primary Outcomes (2)

• Malignancy excluding non-melanoma skin cancer (NMSC)

  Malignancy excluding non-melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.

  from 01 July 2018 through to 31 March 2025

• venous thromboembolic events (VTE),(deep venous thrombosis [DVT] and pulmonary embolism [PE])

  deep venous thrombosis \[DVT\] and pulmonary embolism \[PE\]. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.

  from 01 July 2018 through to 31 March 2025

Secondary Outcomes (13)

• Non melanoma skin cancer (NMSC)

  from 01 July 2018 through to 31 March 2025

• Lung cancer

  from 01 July 2018 through to 31 March 2025

• Lymphoma

  from 01 July 2018 through to 31 March 2025

• Serious infections

  from 01 July 2018 through to 31 March 2025

• Opportunistic infections (e.g., tuberculosis)

  from 01 July 2018 through to 31 March 2025

Study Arms (4)

Cohort 1 (Tofacitinib cohort):

Initiation of tofacitinib (i.e., first ever prescription) from 01 July 2018 through to 31 March 2025

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

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

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date \[i.e. date of first prescription for tofacitinib\].

Sponsors & Collaborators

• Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa: lead
• Pfizer: collaborator

Study Sites (5)

Imelda General Hospital

Bonheiden, 28202, Belgium

RECRUITING

AZ Delta vzw

Roeselare, 8800, Belgium

RECRUITING

Acibadem City Clinic Tokuda University Hospital

Sofia, 1407, Bulgaria

RECRUITING

General Hospital of Athens "Evangelismos"

Ellinikó, Attica, 16777, Greece

RECRUITING

Lithuanian University of Life Sciences

Kaunas, 44307, Lithuania

NOT YET RECRUITING

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MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Manuel MD Barreiro, PhD

  Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva María Rodríguez

CONTACT

+34 691 08 42 07; secretariacientifica1@geteccu.org

Manuel MD Barreiro, PhD

CONTACT

manubarreiro@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 21, 2024
• Study Start: January 11, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); LI (1); GR (1); BU (1)