Acute Severe Ulcerative Colitis
Conditions
Keywords
Acute severe ulcerative colitis, Upadacitinib, second-line treatments, infliximab, Randomized Controlled Trial
Brief summary
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.
Interventions
DRUGupadacitinib
receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily
DRUGInfliximab
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
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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 infliximab. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response by day 7 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical response by day 14 | 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. |
| clinical remission by day 28, day 42, and day 90 | day 28, day 42, and day 90 | Total Mayo score ≤2 points and no individual subscore \>1 point. |
| Endoscopic response by day 90 | day 90 | A decrease in MES score of ≥1 point, or a decrease of ≥50% from baseline. |
| Endoscopic remission by day 90 | day 90 | MES score ≤1 |
| Endoscopic+clinical response | day 90 | Partial Mayo score ≤1 and MES ≤1 |
| Clinical +FcP remission | day 90 | Partial Mayo score ≤1 and FcP≤250mg/kg |
| Clinical +CRP remission | day 90 | Partial Mayo score ≤1 and CRP≤5mg/L |
| Histologic remission | 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. |
| Histologic improvement | 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. |
| Adverse Reactions | day 90 | Adverse Reactions |
| IBD questionnaire scores | 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. |
| PROMIS-Fatigue SF-7a | 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. |
Countries
China
Contacts
CONTACTYongquan Shi, Ph.D
Outcome results
None listed