CTRI/2023/11/059730尚未招募3 期
A Randomized Controlled Trial Comparing the Time to Achieve ClinicalResponse in Patients with Moderate to Severe Ulcerative Colitis UsingCorticosteroids versus Tofacitinib. - NA
All India Institute of Medical Sciences New Delhi Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients with moderate to severe (as defined
- •by SCCAI score >6 and UCEIS >3)
- •2. Patients who are on optimum dosage of oral
- •(minimum 2.4 g per day) and topical 5-ASA
- •agents, are steroid naïve, or steroid
- •experienced (last dose >12 weeks prior) but
- •not on steroids or azathioprine.
- •3. Anti-TNF/Anti-integrin naïve or
- •experienced (intolerant or non-responder)
- •but last dose =2 months back.
- •4. Concomitant therapy alloweda) Topical steroid and topical 5-ASA
- •therapy (if stable for last 2 weeks)
- •b) Budesonide up to 9 mg/day. Stable
- •dose for at least 2 weeks prior to
- •baseline period or Budesonide
- •tapering 3 mg every 3 weekly.
- •c) Patients on stable doses of oral 5-
- •ASA (5-amino salicylic acid) for
- •past 4 weeks.
- •5. Women of childbearing age should agree to
- •avoid conception during the study period.
- •6. Patients giving written informed consent.
排除标准
- •1) Age <18 years, >65 years
- •2) Patients with acute severe ulcerative colitis
- •3) Clinical signs of fulminant colitis or toxic
- •4) Patients with a steroid refractory disease.
- •5) Indeterminate, ischemic, infectious or
- •Crohn’s colitis
- •6) Received no treatment for UC in past i.e.,
- •treatment-naïve
- •7) If the subject has received the following
- •therapya. Intravenous corticosteroids within 2
- •weeks prior to baseline
- •b. Anti-TNF therapy (e.g., infliximab,
- •adalimumab, or certolizumab)
- •within 8 weeks prior to baseline
- •8) Pregnancy and lactation
- •9) Concomitant Clostridioides difficile
- •10) Severe comorbid medical illness
- •a. Cardiac: NYHA II or higher congestive
- •heart failure
- •b. Renal: Creatine clearance (Cockcroft
- •Gault formula) <40 ml/min
- •c. Severe hepatic impairment
- •d. Malignancies or a history of
- •malignancies
- •e. Significant trauma or major surgery
- •within 4 weeks
- •f. History of bowel surgery within 6
- •12) Contraindication to Tofacitinib including:
- •a. Severe hepatic impairment
- •c. Active Tuberculosis
- •d. H/O deep venous thrombosis DVT or
- •thrombotic disorder
研究者
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