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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib group | Experimental | Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily. |
|
| Infliximab group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| upadacitinib | Drug | receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 14 |
| clinical remission by day 28, day 42, and day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongquan Shi, Ph.D | Contact | 86-029-84771535 | shiyquan@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankang Central Hospital | Recruiting | Ankang | Shaanxi | 725000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40721074 | Background | Honap S, St-Pierre J, Colwill M, Patel K, Le Berre C, Caron B, Nogami A, Kobayashi T, Altwegg R, Laharie D, Hebuterne X, Nachury M, Roblin X, Uzzan M, Kotze PG, Lukas M, Vieujean S, D'Amico F, Albshesh A, Guillo L, Fumery M, Nancey S, Ye BD, Bergemalm D, Halfvarson J, Buisson A, Karmiris K, Rubin DT, Vicaut E, Peyrin-Biroulet L; ATTRACT Study Group. Comparative Effectiveness of Tofacitinib vs Upadacitinib for the Treatment of Acute Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2026 Mar;24(3):784-793. doi: 10.1016/j.cgh.2025.07.025. Epub 2025 Jul 26. | |
| 39236736 |
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| ID | Term |
|---|---|
| C000613732 | upadacitinib |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Infliximab | Drug | 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 |
|
Total Mayo score ≤2 points and no individual subscore >1 point. |
| 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. | day 90 |
| Endoscopic remission by day 90 | MES score ≤1 | day 90 |
| Endoscopic+clinical response | Partial Mayo score ≤1 and MES ≤1 | day 90 |
| Clinical +FcP remission | Partial Mayo score ≤1 and FcP≤250mg/kg | day 90 |
| Clinical +CRP remission | Partial Mayo score ≤1 and CRP≤5mg/L | 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. | 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. | day 90 |
| Adverse Reactions | Adverse Reactions | 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. | 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. | day 0 and day 90 |
| 3201 Hospital | Recruiting | Hanzhong | Shaanxi | 710005 | China |
|
| Xijing Hosipital of Digestive Disease | Recruiting | Xi'an | Shaanxi | 710005 | China |
|
| Shaanxi Provincial Nuclear Industry 215 Hospital | Recruiting | Xianyang | Shaanxi | 712000 | China |
|
| Background |
| Choy MC, Li Wai Suen CFD, Con D, Boyd K, Pena R, Burrell K, Rosella O, Proud D, Brouwer R, Gorelik A, Liew D, Connell WR, Wright EK, Taylor KM, Pudipeddi A, Sawers M, Christensen B, Ng W, Begun J, Radford-Smith G, Garg M, Martin N, van Langenberg DR, Ding NS, Beswick L, Leong RW, Sparrow MP, De Cruz P. Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Nov;9(11):981-996. doi: 10.1016/S2468-1253(24)00200-0. Epub 2024 Sep 2. |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |