Retrospective Observational Comparison Study Between Ustekinumab and Tofacitinib as Third Line Therapy in a Multicenter Cohort of Patients With Refractory Ulcerative Colitis.
Launched by IRCCS SAN RAFFAELE · Feb 13, 2023
Trial Information
Current as of April 25, 2025
Completed
Keywords
ClinConnect Summary
This is an observational, retrospective, international multicenter study on the comparison of ustekinumab (anti-IL12-23) and tofacitinib (pan JAK inhibitor) used as third-line therapy in UC cases.
The aim of this retrospective multicentric observational study is to determine which between ustekinumab (anti-IL12-23) and tofacitinib (pan JAK inhibitor) as third-line therapy in UC cases refractory to both anti-TNFα and vedolizumab (inhibitor of α4β7 integrin) is the best compound to achieve disease control. The primary goal is to compare the hospitalization rate, surgery rate, drug optimizati...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥18 years;
- • Established diagnosis of UC, defined according to ECCO standard of care
- • Documented failure to both anti-TNFα (irrespectively of the number) and vedolizumab
- • Ustekinumab or tofacitinib as third-line therapy
- • Last follow-up at 24 +/-4 weeks from the start of Ustekinumab or tofacitinib
- Exclusion Criteria:
- • • Patients with unclassified colitis or Crohn disease
About Irccs San Raffaele
IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milano, , Italy
Patients applied
Trial Officials
MARIANGELA ALLOCCA
Principal Investigator
IRCCS San Raffaele
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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