Comparative efficacy and safety of upadacitinib versus oral prednisolone for the induction and maintenance of remission in moderate to severe ulcerative colitis: a prospective, multicenter, open-label, randomised controlled trial (PREDUPA Trial)
Moderate-to-severe ulcerative colitis
This study will be a prospective, multicenter, open-label, randomised controlled trial in Kuwait. It is comprised of an 8-week induction trial followed by a 40-week maintenance trial with a treat-through design. The sample population will include all patients between the ages of 18 – 60 with moderate-to-severe UC. To be enrolled, patients must have a Modified Mayo Score (MMS; range 0 – 9, with higher scores being indicative of greater severity of UC) between 4 – 9 with an endoscopic subscore of 2 – 3 at baseline (week 0). The endoscopic subscores will be based on images or videos taken during colonoscopies done by consultant gastroenterologists or endoscopists at multiple centres across Kuwait. The endoscopic Mayo scores will be validated by a single IBD specialist who will then be blinded to treatment allocation, clinical response and endoscopy time point throughout the whole 48-week study period. Eligible patients will then be randomly assigned in a 1:1 ratio to receive either Upadacitinib (45mg daily) or oral Prednisolone (40mg daily, tapered by 5mg every week) for a total duration of 8 weeks. Participants who achieve clinical response at week 8 will proceed into the maintenance trial whereby all responders will either continue or commence treatment with Upadacitinib at a maintenance dose for 40 additional weeks (15mg once daily and 30mg once daily for biologic-naïve and biologic-experienced patients, respectively).
1. Males + Females with moderate-to-severe UC 2. Age 18 – 60 years 3. All durations of disease 4. All extents of disease (proctitis / left-sided colitis / pancolitis) 5. Previously failed to respond to conventional therapies and/or anti-TNF therapy 6. Biologic-naïve 7. On a stable dose of 5-ASA or immunomodulator four weeks prior to the start of the study
1. Pregnant / lactating 2. Crohn’s colitis 3. Latent or active TB 4. Active infection 5. Current or past malignancy 6. Active or past thromboembolic disease