Actively Recruiting
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)
Led by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Updated on 2024-06-21
104
Participants Needed
5
Research Sites
115 weeks
Total Duration
On this page
Sponsors
G
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Diagnosed with ulcerative colitis according to ECCO guidelines
- Enrolled in the UR-CARE registry with at least 12 months of medical history before the study start
- Signed informed consent to participate in the study
- Minimum follow-up duration of 12 months available for safety evaluation
You will not qualify if you...
- Patients not meeting all inclusion criteria
- Patients with any records of Crohn's disease or unspecified inflammatory bowel disease between the last ulcerative colitis diagnosis and the first prescription date for tofacitinib
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Imelda General Hospital
Bonheiden, Belgium, 28202
Actively Recruiting
2
AZ Delta vzw
Roeselare, Belgium, 8800
Actively Recruiting
3
Acibadem City Clinic Tokuda University Hospital
Sofia, Bulgaria, 1407
Actively Recruiting
4
General Hospital of Athens "Evangelismos"
Ellinikó, Attica, Greece, 16777
Actively Recruiting
5
Lithuanian University of Life Sciences
Kaunas, Lithuania, 44307
Not Yet Recruiting
Research Team
E
Eva María Rodríguez
CONTACT
M
Manuel MD Barreiro, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here