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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Safety and efficacy of the drug
Safety and efficacy of the drug
Ankang Central Hospital
Ankang, Shaanxi, China
RECRUITING3201 Hospital
Hanzhong, Shaanxi, China
RECRUITINGXijing Hospital
Xi'an, Shaanxi, China
RECRUITINGShaanxi Provincial Nuclear Industry 215 Hospital
Xianyang, Shaanxi, China
RECRUITINGPrimary Outcome Measure
clinical response by day 7 (defined as a reduction in Lichtiger score to \<10 points with a decrease of ≥3 points from baseline improvement in rectal bleeding, and decreased stool frequency to ≤4 per day).
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.
clinical response by day 14
Defined as mayo score decrease of ≥30% and ≥3 points from baseline, accompanied by a decrease in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of 0 or 1.
Time frame: day 14
clinical remission by day 28, day 42, and day 90
Total Mayo score ≤2 points and no individual subscore \>1 point.
Time frame: day 28, day 42, and day 90
Endoscopic response by day 90
A decrease in MES score of ≥1 point, or a decrease of ≥50% from baseline.
Time frame: day 90
Endoscopic remission by day 90
MES score ≤1
Time frame: day 90
Endoscopic+clinical response
Partial Mayo score ≤1 and MES ≤1
Time frame: day 90
Clinical +FcP remission
Partial Mayo score ≤1 and FcP≤250mg/kg
Time frame: day 90
Clinical +CRP remission
Partial Mayo score ≤1 and CRP≤5mg/L
Time frame: day 90
Histologic remission
typically defined as the absence of signs of neutrophilic infiltration. The specific criterion is a score below 2B.0, i.e., no increased neutrophils in the lamina propria.
Time frame: day 90
Histologic improvement
when assessing treatment efficacy, a score ≤ 3.1 (intraepithelial neutrophilic infiltration involving \< 50% of crypts) is used as the threshold for histologic improvement.
Time frame: day 90
Adverse Reactions
Adverse Reactions
Time frame: day 90
IBDQ and fatigue questionnaire scores
IBDQ and fatigue questionnaire scores
Time frame: day 0 and day 90
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