Actively Recruiting
Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis(UPFRONT)
Led by Yongquan Shi · Updated on 2026-04-22
46
Participants Needed
4
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis(UPFRONT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with ASUC
- Aged 18 years or older
- No gender restriction
You will not qualify if you...
- Contraindication, allergy, or intolerance to upadacitinib or glucocorticoids
- Need for immediate colectomy
- Diagnosis of Crohn's disease
- Confirmed intestinal infection
- Hemodynamic instability
- Clinically significant cytomegalovirus infection
- Current malignancy
- Severe systemic diseases involving heart, lungs, liver, kidneys, hematologic system, or other organs
- Pregnant or breastfeeding women
- Unwilling to participate in the clinical study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Ankang Central Hospital
Ankang, Shaanxi, China, 710005
Actively Recruiting
2
3201 Hospital
Hanzhong, Shaanxi, China, 710005
Actively Recruiting
3
Xijing Hospital
Xi'an, Shaanxi, China, 710005
Actively Recruiting
4
Shaanxi Provincial Nuclear Industry 215 Hospital
Xianyang, Shaanxi, China, 710005
Actively Recruiting
Research Team
Y
Yongquan Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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