Clinical Trials in Ireland / NCT05494606
Active, not recruiting
Observational
An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice
NCT05494606 · tracked via the Priya Life Science Ireland tracker
Condition(s) studied
Ulcerative Colitis
Study summary
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.
Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide.
Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Eligibility
Inclusion Criteria:
* Participants with a diagnosis of moderate to severe Ulcerative colitis (UC).
* Participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study.
* Participants prescribed upadacitinib in accordance with the approved local label.
* Participants able to understand and communicate with the investigator and comply with the requirements of the study.
* Participants willing to continue with study documentation after cessation of upadacitinib.
* Participants willing and able to participate in the collection of patient-reported data via cloud based mobile application using the provided smart device (iPhone).
Exclusion Criteria:
* Participants with any contraindication to upadacitinib.
* Participants previously exposed to upadacitinib in a clinical trial.
* Participants currently participating in interventional research (not including noninterventional study, postmarketing observational study (PMOS), or registry participation).
Primary outcome measure(s)
- Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score — Up to approximately week 156
The first clinical response (CR) per partial adapted mayo score is defined as a decrease from baseline in partial adapted mayo score ≥ 1 point and ≥ 30%, plus a decrease from baseline in the rectal bleeding score \[RBS\] ≥ 1 or absolute RBS ≤ 1. Median time to achieve the first CR per partial adapted mayo score will be reported - Percentage of Participants Achieving Clinical Response (CR) per Partial Adapted Mayo Score Among those who Achieved CR at Completion of Upadacitinib Induction (either at Week 8 or at Week 16) — Week 52
Clinical response (CR) per partial adapted mayo score is defined as a decrease from baseline in partial adapted mayo score ≥ 1 point and ≥ 30%, plus a decrease from baseline in the rectal bleeding score \[RBS\] ≥ 1 or absolute RBS ≤ 1.
Trial sites (153)
| Facility | City | Region | Status |
|---|---|---|---|
| Gedyt /ID# 249611 | Ciudad Autonoma de Buenos Aire | Buenos Aires F.D. | |
| Hospital Britanico de Buenos Aires /ID# 249605 | Ciudad Autonoma de Buenos Aire | Buenos Aires F.D. | |
| Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612 | Córdoba | Argentina | |
| Blacktown Hospital /ID# 248354 | Blacktown | New South Wales | |
| Nepean Hospital /ID# 248351 | Kingswood | New South Wales | |
| Coral Sea Clinical Research institute /ID# 248352 | North Mackay | Queensland | |
| Austin Health /ID# 249133 | Heidelberg | Victoria | |
| The Royal Melbourne Hospital /ID# 248353 | Parkville | Victoria | |
| University of Calgary /ID# 259183 | Calgary | Alberta | |
| Gastroenterology and Internal Medicine Research Institution /ID# 251463 | Edmonton | Alberta | |
| Dr. J Siffledeen Profess Pract /ID# 256903 | Edmonton | Alberta | |
| Six08 Gastroenterology /ID# 259452 | Lethbridge | Alberta | |
| Dr. Sundeep Singh, Inc /ID# 251471 | Kelowna | British Columbia | |
| The Moncton Hospital /ID# 257337 | Moncton | New Brunswick | |
| Barrie GI Associates /ID# 264978 | Barrie | Ontario | |
| Hamilton Health Sciences - McMaster University Medical Centre /ID# 256819 | Hamilton | Ontario | |
| London Health Sciences Center- University Hospital /ID# 258472 | London | Ontario | |
| West GTA Endoscopy /ID# 263221 | Mississauga | Ontario | |
| Scott Shulman Medicine Professional Corporation /ID# 256826 | North Bay | Ontario | |
| Toronto Immune and Digestive Health Institute Inc /ID# 256827 | North York | Ontario | |
| Toronto Digestive Disease Associates /ID# 258914 | Vaughan | Ontario | |
| CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 260528 | Montreal | Quebec | |
| Royal Victoria Hospital / McGill University Health Centre /ID# 258470 | Montreal | Quebec | |
| Diex Recherche Québec /ID# 262796 | Québec | Quebec | |
| Iscare Klinické Centrum /ID# 259811 | Prague | Praha 9 | |
| SurGal Clinic /ID# 259809 | Brno | South Moravian | |
| Nemocnice Ceske Budejovice a.s. /ID# 259810 | České Budějovice | Czechia | |
| Fakultni nemocnice Kralovske Vinohrady /ID# 261535 | Prague | Czechia | |
| Fakultni Thomayerova nemocnice /ID# 261626 | Prague | Czechia | |
| Chu de Nice-Hopital L'Archet Ii /Id# 251938 | Nice | Alpes-Maritimes | |
| APHM - Hopital Nord /ID# 252049 | Marseille | Bouches-du-Rhone | |
| CHU de Besancon - Jean Minjoz /ID# 252966 | Besançon | Doubs | |
| CHU NIMES - Hopital Caremeau /ID# 254790 | Nîmes | Gard | |
| Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 252496 | Colmar | Grand Est | |
| CHU Toulouse - Hopital Rangueil /ID# 251879 | Toulouse | Haute-Garonne | |
| CHU Montpellier - Hopital Saint Eloi /ID# 252041 | Montpellier | Herault | |
| CHU Grenoble - Hopital Michallon /ID# 251937 | La Tronche | Isere | |
| Clinique Santé Atlantique /ID# 252581 | Saint-Herblain | Loire-Atlantique | |
| CHU Reims - Hôpital Robert Debre /ID# 252017 | Reims | Marne | |
| CHRU Lille - Hopital Claude Huriez /ID# 251971 | Lille | Nord |
+ 113 more sites — see the full list on the official registry below.
More AbbVie trials in Ireland
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A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
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Other trials for the same condition
A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis
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A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05494606 on ClinicalTrials.gov ↗ ← All trials in Ireland