Acute Severe Ulcerative Colitis
Conditions
Keywords
acute severe ulcerative colitis, Upadacitinib, Corticosteroids, First-Line Therapy, Randomized Controlled Trial
Brief summary
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.
Interventions
DRUGUpadacitinib
Safety and efficacy of the drug
DRUGCorticosteroid
Safety and efficacy of the drug
Sponsors
Yongquan Shi
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 glucocorticoids. * 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 |
|---|---|---|
| Primary Outcome Measure | 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 |
| IBDQ and fatigue questionnaire scores | day 0 and day 90 | IBDQ and fatigue questionnaire scores |
Countries
China
Contacts
CONTACTYongquan Shi
Outcome results
None listed