Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（UPFRONT）
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Upadacitinib, Corticosteroid.
- Who it may be relevant to
- Registry conditions: Acute Severe Ulcerative Colitis. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis: Multicenter, Open-label, Non-inferiority, Randomized Controlled Study
Overview
The goal of this clinical trial is to learn comparative effectiveness and safety of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis. The main questions it aims to answer are: 1. Whether upadacitinib can effectively induce remission in acute severe ulcerative colitis with an efficacy non-inferior to that of corticosteroids. 2. What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will compare upadacitinib with corticosteroids to evaluate the efficacy of upadacitinib in the treatment of acute severe ulcerative colitis.Participants will: 1. Upadacitinib group: Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily. 2. Corticosteroid group: Methylprednisolone for injection 60 mg/day. If clinical response is achieved, switch to oral prednisone acetate tablets after 5 days (calculated at 0.75 mg/kg/day), followed by a weekly prednisone taper of 5 mg. When the dose is reduced to 20 mg, taper by 2.5 mg weekly until discontinued, with mesalazine 4 g/day as maintenance therapy. 3. Take drug Upadacitinib or Corticosteroid every day for 3 months 4. Visit the clinic once every 2 weeks for checkups and tests 5. Record the patient's bowel movements and the presence of symptoms such as abdominal pain, while performing colonoscopy, ultrasound examination, and blood tests at the specified time points.
Interventions
- Drug Upadacitinib
Safety and efficacy of the drug - Drug Corticosteroid
Safety and efficacy of the drug
Primary outcome measures
- Primary Outcome Measure [Time frame: The primary outcome was assessed by the investigator between days 3 and 7, with patients recorded as clinical responders if they had the primary outcome on any day in this assessment window.]
Secondary outcome measures (11)
- clinical response by day 14 [Time frame: day 14]
- clinical remission by day 28, day 42, and day 90 [Time frame: day 28, day 42, and day 90]
- Endoscopic response by day 90 [Time frame: day 90]
- Endoscopic remission by day 90 [Time frame: day 90]
- Endoscopic+clinical response [Time frame: day 90]
- Clinical +FcP remission [Time frame: day 90]
- Clinical +CRP remission [Time frame: day 90]
- Histologic remission [Time frame: day 90]
- Histologic improvement [Time frame: day 90]
- Adverse Reactions [Time frame: day 90]
- IBDQ and fatigue questionnaire scores [Time frame: day 0 and day 90]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with ASUC
- Aged 18 years or older.
- No gender restriction.
Exclusion criteria
- Presence of contraindications, allergy, or intolerance to upadacitinib or glucocorticoids.
- Patients requiring immediate colectomy; diagnosis of Crohn's disease; confirmed intestinal infection; hemodynamic instability; clinically significant cytomegalovirus infection; current malignancy.
- Presence of severe underlying systemic diseases involving the heart, lungs, liver, kidneys, hematologic system, or other organ systems.
- Pregnant or breastfeeding women.
- Unwilling to participate in the clinical study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Ankang Central Hospital — Ankang
- 3201 Hospital — Hanzhong
- Xijing Hospital — Xi'an
- Shaanxi Provincial Nuclear Industry 215 Hospital — Xianyang
Publications
- D'Haens G, Lemmens L, Geboes K, Vandeputte L, Van Acker F, Mortelmans L, Peeters M, Vermeire S, Penninckx F, Nevens F, Hiele M, Rutgeerts P. Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis. Gastroenterology. 2001 May;120(6):1323-9. doi: 10.1053/gast.2001.23983. PMID 11313301
- Choy MC, Li Wai Suen CFD, Con D, Boyd K, Pena R, Burrell K, Rosella O, Proud D, Brouwer R, Gorelik A, Liew D, Connell WR, Wright EK, Taylor KM, Pudipeddi A, Sawers M, Christensen B, Ng W, Begun J, Radford-Smith G, Garg M, Martin N, van Langenberg DR, Ding NS, Beswick L, Leong RW, Sparrow MP, De Cruz P. Intensified versus standard dose infliximab induction therapy for steroid-refractory acute sever PMID 39236736
Identifiers
NCT: NCT07546097 · KY20252556-F-1-1