Upadacitinib
Drugreceiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily
NCT Number: NCT07550673
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 4
Ankang Central Hospital, Ankang, Shaanxi, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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 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: 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 28, day 42, and day 90
Total Mayo score ≤2 points and no individual subscore >1 point.
Time frame: day 90
A decrease in MES score of ≥1 point, or a decrease of ≥50% from baseline.
Time frame: day 90
MES score ≤1
Time frame: day 90
Partial Mayo score ≤1 and MES ≤1
Time frame: day 90
Partial Mayo score ≤1 and FcP≤250mg/kg
Time frame: day 90
Partial Mayo score ≤1 and CRP≤5mg/L
Time frame: day 90
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
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
Time frame: day 0 and day 90
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
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.
Contact information is provided by the study sponsor or research team.
Xijing Hospital of Digestive Diseases
Other
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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