Upadacitinib Co-therapy with Corticosteroids in Early Acute Severe Ulcerative Colitis (ACESO)
Study Design: A Phase III randomised placebo controlled double blinded trial
Disease Area: Inflammatory Bowel Disease (IBD)
Funder: AbbVie Ltd
Sponsor: Hull UniversityTeaching Hospitals NHS Trust
Chief Investigator: Prof. Shaji Sebastian
Trial registration: ISRCTN17100156
-
Project overview
-
Trial Team
-
Participating Sites
-
Patient Information
-
Dissemination
Summary
Early addition of the rapidly acting agent Upadacitinib to conventional therapy using IV corticosteroids may reduce the need for medical rescue therapy and/or rescue surgical therapy in patients with ASUC.
What we plan to do
Primary objective
The overall study objective is to evaluate the clinical efficacy of Upadacitinib as combined treatment with intravenous steroids in patients with ASUC.
Secondary objectives
- To evaluate the impact of combination therapy (Upadacitinib + steroids) on the need for rescue medical or surgical therapy
- Evaluate the safety of use of combination therapy (Upadacitinib + steroids) in the setting of ASUC
- Evaluate the efficacy and safety of the combination (Upadacitinib + steroids) in a subgroup of patients with prior exposure to advanced therapies
- Determine the impact of combination therapy (Upadacitinib + steroids) on a range of other indices of treatment response including duration of hospital stay, time to treatment response, quality of life using CUCQ-32, patient preference using DISCUSS tool and 2 Validated psychometric tools (Decision Conflict Scale & Decision Regret Scale)
- Collect biobanking samples to develop and refine high risk immunophenotype in ASUC who will benefit from combination (Upadacitinib + steroids) therapy.
- Health economic assessment of treatment in ASUC
Chief Investigator
Prof Shaji Sebastian Consultant Gastroenterologist & IBD Service Lead Clinician - Hull University Teaching Hospitals NHS Trust
Co-Lead Investigators
Dr Kamal Patel Consultant Gastroenterologist - St George's University Hospitals NHS Foundation Trust
Dr Tim Raine Consultant Gastroenterologist - Cambridge University Hospitals NHS Foundation Trust
HHTU Study team
Mahboobeh Haji Sadeghi - Trial Manager
Charlotte Thompson - Trial Coordinator
Paul Bradley - Trial Coordinator
Beccy Acaster - Data Manager
Sarah Sumpter - Senior Data Manager
Kerri Morris - Trial Administrator
Bronwen Williams - Operations Manager
Collaborators
Prof Judith Cohen Director of Hull Health Trials Unit - University of Hull
Dr Chao Huang Senior Lecturer in Medical Statistics - University of Hull
Email address
aceso@hyms.ac.uk
Participating Sites and their Project Investigators
Hull University Teaching Hospitals NHS - Prof. Shaji Sebastian
Cambridge University Hospitals NHS Foundation Trust - Dr Tim Raine
St George's University Hospitals NHS Foundation Trust - Dr Sailish Honap
Glasgow Royal Infirmary - Prof. Daniel Gaya
Shrewsbury and Telford Hospitals NHS Trust - Dr Jeffery Butterworth
The Royal London Hospital, Whitechapel - Dr Gareth Parkes
Taunton and Somerset NHS Foundation Trust - Dr Emma Wesley
Newcastle Upon Tyne Hospitals NHS Foundation Trust - Dr Richard Alexander Speight
NHS Lothian Western General Hospital - Dr Shahida Din
Chelsea and Westminster Hospitals NHS Foundation Trust - Dr Alice Moore
University Hospitals Cardiff - Dr Dharmaraj Durai
Guy's and St Thomas' NHS Foundation Trust - Dr Shuvra Ray
South Eastern Health and Social Care - Dr Patrick Allen
London North West University Healthcare NHS Trust (Northwick Park Hospital) - Dr Ravi Misra
Kettering General Hospital NHS Foundation Trust - Dr Ajay Verma
Imperial College Healthcare NHS Trust - Dr James Alexander
Royal Wolverhampton NHS Trust - Dr Philip Harvey
King's College Hospital NHS Foundation Trust - Dr Alexandra Kent
University Hospitals Coventry and Warwickshire NHS Trust - Dr Ben Disney
Leeds Teaching Hospitals NHS Trust - Dr Christian Selinger
Royal Devon and Exeter NHS Foundation Trust - Dr Jonathan Digby-Bell
Pennine Acute Hospitals NHS Trust - Prof. Jimmy Limdi
University Hospital Southampton NHS Foundation Trust - Dr Fraser Cummings
Oxford Health NHS Foundation Trust - Dr Alissa Walsh
Luton and Dunstable University Hospital -Dr Matthew Johnson
Queen Elizabeth University Hospital (Glasgow) - Prof. Daniel Gaya
Watch this space.
Collaborators
