This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis with efficacy non-inferior to infliximab? (2) What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will also compare the efficacy of upadacitinib with that of corticosteroids to assess its therapeutic effect. Participants will be assigned to either the upadacitinib group (receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily) or the infliximab group (receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
226
receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily
receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose
Ankang Central Hospital
Ankang, Shaanxi, China
RECRUITING3201 Hospital
Hanzhong, Shaanxi, China
RECRUITINGXijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China
RECRUITINGShaanxi Provincial Nuclear Industry 215 Hospital
Xianyang, Shaanxi, China
RECRUITINGClinical response by day 7
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
IBD questionnaire scores
IBDQ and fatigue questionnaire scores，The total score ranges from 32 to 224 points. The closer the score is to 224, the less the patient is troubled by the disease and the higher their quality of life.
Time frame: day 0 and day 90
PROMIS-Fatigue SF-7a
Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a.The total score ranges from 7 to 35 points. The higher the score, the more severe the fatigue caused by the disease, and timely attention to the patient's condition is needed.
Time frame: day 0 and day 90
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