None listed
Conditions
Brief summary
INDUCE is a multicentre prospective randomised controlled trial to compare the efficacy and safety (using standardised clinical outcomes plus non-invasive monitoring of mucosal healing using gastrointestinal ultrasound of Upadacitinib vs Corticosteroid in patients with Ulcerative Colitis and Crohn's Disease flares. We hypothesize that upadacitinib is non-inferior in terms of efficacy to prednisolone for disease flares, with no difference in rate of adverse event.
Interventions
Participants in this study will be adults attending hospital for inpatient or outpatient care with moderate to severely active Ulcerative Colitis or Crohn's Disease flares.
Follow up with clinical, biochemical and intestinal ultrasound will occur at week 0, 2 and 6 with safety follow-up at week 12.
The interventional arm (randomised) will be upadacitinib for a 6 week period for flare management. Upadacitinib will be dosed at 45mg oral tablet once daily.
Sponsors
Mater Misericordiae Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria 1. Aged between 18-65 2. Have ability to give informed consent 3. Moderately active disease flares evidenced by PRO-2 score of greater than or equal to 4 4. Have confirmed objective evidence of UC or CD flares by C-reactive protein (CRP), Intestinal Ultrasound (IUS), Faecal Calprotectin (FCP) or Endoscopy 5. Suitable to be prescribed a weaning course of oral corticosteroid for induction of remission 6. Completed pre-screening tests (blood test and chest x-ray) for upadacitinib therapy, including hepatitis B, hepatitis C, human immunodeficiency virus, varicella zoster virus, tuberculosis, mumps, measles and rubella
Exclusion criteria
Exclusion criteria 1. Evidence of ASUC (by truelove and witts criteria) 2. Pregnant or breastfeeding 3. Evidence of gastrointestinal infection on clinical evaluation 4. History of solid organ or haematological malignancy within 2 years, significant cardiorespiratory disease, thrombophilia or thromboembolic disorder 5. Any absolute contraindication to corticosteroids 6. Be part of any other interventional trial 7. Current or prior upadacitinib use 8. Greater than 7 days of oral corticosteroid prior to screening or greater than 24 hours of IV corticosteroid 9. Chronic liver disease (Child Pugh B or C), chronic hepatitis B 10. Active infections, including hepatitis B or C, human immunodeficiency virus, varicella zoster virus, tuberculosis, mumps, measles and rubella 11. History of hypersensitivity or adverse events to other JAK inhibitor
Outcome results
None listed