Stelara fOr ChRonic AntibioTic rEfractory pouchitiS (SOCRATES): A Belgian Open Label Multicenter Pilot-study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- The percentage of subjects achieving clinically relevant steroid-free remission
研究概览
简要总结
To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.
详细描述
This study is a Belgian prospective open label multicenter study to evaluate the efficacy and safety of ustekinumab in the treatment of relapsing or chronic antibiotic refractory pouchitis during a 48-week treatment period. Twenty subjects with a RPC and IPAA for UC who have developed relapsing or chronic antibiotic refractory pouchitis will be enrolled.
All patients will receive intravenously (IV) ustekinumab ~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48. All subjects will receive concomitant antibiotic treatment with ciprofloxacin or metronidazole from baseline through Week 4. Intravenous induction doses will be 260mg for patients <55kg, 390mg for patients between 55 and 85kg, and 520mg for patients with a body weight >85 kg.
Clinical and biochemical evaluation will be planned every 8 weeks. Efficacy will be assessed at Week 16 and Week 48 using mPDAI and PDAI scores, therefor a pouchoscopy with biopsy sampling will be performed. Patients who do not achieve partial response (reduction of mPDAI score by ≥2 points from baseline) at Week 16 will be discontinued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has a history of ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC)
- •The subject has pouchitis that is (a) relapsing or (b) chronic antibiotic refractory, defined by an mPDAI score ≥5 assessed as the average from 3 days immediately prior to the baseline endoscopy visit and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either (a) ≥3 recurrent episodes within the last year, each treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline endoscopy visit
排除标准
- •Crohn's disease (CD), CD-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (IPS), isolated or predominant cuffitis, infectiouw pouchitis, diverting ostomy or mechanical complications of the pouch
- •Previous treatment with an anti-IL12/23 or an anti-IL23 antibody
- •Any investigational or approved biologic agent within 30 days of baseline
- •Nonbiologic investigational therapy or tofacitinib within 30 days prior to baseline
- •Active or untreated latent tuberculosis (TB)
- •Chronic hepatitis B virus (HBV) infection, chronic hepatitis C virus (HCV) infection, a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at screening) or subject is immunodeficient
- •Active severe infection (e.g. sepsis, cytomegalovirus, listeriosis or C. difficile)
- •History of malignancy or current malignancy
研究组 & 干预措施
Open label ustekinumab
All patients will receive intravenously (IV) ustekinumab ~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48. All subjects will receive concomitant antibiotic treatment with ciprofloxacin or metronidazole from baseline through Week 4. Intravenous induction doses will be 260mg for patients <55kg, 390mg for patients between 55 and 85kg, and 520mg for patients with a body weight >85 kg.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
The percentage of subjects achieving clinically relevant steroid-free remission
时间窗: 16 weeks after baseline
mPDAI score \<5 and a reduction by ≥2 points from baseline
次要结局
- The percentage of subjects achieving clinically relevant steroid-free remission(48 weeks after baseline)
- The percentage of subjects achieving partial response(48 weeks after baseline)
- Change in mPDAI endoscopic subscore(At Week 16 and 48 compared to baseline)
- Change in total mPDAI score(At Week 16 and 48 compared to baseline)
- Change in mPDAI symptomatic subscore(At Week 16 and 48 compared to baseline)
- Change in European Quality of Life 5 Dimensions (EQ-5D)(At Week 16, 32 and 48 compared to baseline)
- Time to clinically relevant remission(Within 48 weeks after baseline)