Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（UPFRONT）

Официальное название

Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis: Multicenter, Open-label, Non-inferiority, Randomized Controlled Study

Обзор

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.

Вмешательства

• Препарат Upadacitinib
  Safety and efficacy of the drug
• Препарат Corticosteroid
  Safety and efficacy of the drug

Первичные конечные точки

• Primary Outcome Measure [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 (11)

• 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]
• IBDQ and fatigue questionnaire scores [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 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.

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 Hospital — Сиань
• Shaanxi Provincial Nuclear Industry 215 Hospital — Xianyang

Публикации

• D'Haens G, Lemmens L, Geboes K, Vandeputte L, Van Acker F, Mortelmans L, Peeters M, Vermeire S, Penninckx F, Nevens F, Hiele M, Rutgeerts P. Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis. Gastroenterology. 2001 May;120(6):1323-9. doi: 10.1053/gast.2001.23983. PMID 11313301
• 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: NCT07546097 · KY20252556-F-1-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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