Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）

Официальное название

Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат upadacitinib
  receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily
• Препарат Infliximab
  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

Первичные конечные точки

• Clinical response by day 7 [Срок оценки: 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.]

Вторичные конечные точки (12)

• clinical response by day 14 [Срок оценки: day 14]
• clinical remission by day 28, day 42, and day 90 [Срок оценки: day 28, day 42, and day 90]
• Endoscopic response by day 90 [Срок оценки: day 90]
• Endoscopic remission by day 90 [Срок оценки: day 90]
• Endoscopic+clinical response [Срок оценки: day 90]
• Clinical +FcP remission [Срок оценки: day 90]
• Clinical +CRP remission [Срок оценки: day 90]
• Histologic remission [Срок оценки: day 90]
• Histologic improvement [Срок оценки: day 90]
• Adverse Reactions [Срок оценки: day 90]
• IBD questionnaire scores [Срок оценки: day 0 and day 90]
• PROMIS-Fatigue SF-7a [Срок оценки: day 0 and day 90]

Критерии участия

Критерии включения

• Patients diagnosed with ASUC
• Aged 18 years or older.
• No gender restriction.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Ankang Central Hospital — Ankang
• 3201 Hospital — Hanzhong
• Xijing Hosipital of Digestive Disease — Сиань
• Shaanxi Provincial Nuclear Industry 215 Hospital — Xianyang

Публикации

• 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 Upad PMID 40721074
• 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 sever PMID 39236736

Идентификаторы

NCT: NCT07550673 · KY20252556-F-1-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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