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Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis (STOP)

2026年7月17日 更新者：Assistance Publique Hopitaux De Marseille

Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis: a Randomized Controlled Trial

This phase IV, multicenter, open-label randomized controlled trial will evaluate whether a JAK inhibitor discontinuation strategy is superior to standard maintenance therapy in adult patients with ulcerative colitis who are in sustained deep remission. A total of 224 patients treated with tofacitinib, upadacitinib, or filgotinib will be randomized to either treatment withdrawal or continuation of maintenance therapy and followed for 104 weeks. The primary objective is to compare safety, efficacy, and patient satisfaction at Week 52, while secondary objectives include assessment of remission maintenance, quality of life, treatment exposure, endoscopic outcomes, and relapse rates

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Background:

Janus kinase (JAK) inhibitors are effective oral therapies for moderate-to-severe ulcerative colitis (UC). Their lack of immunogenicity provides a unique opportunity to evaluate treatment withdrawal and intermittent treatment strategies. However, safety concerns raised by regulatory agencies, including increased risks of infections, venous thromboembolism, major adverse cardiovascular events, and malignancies, support the investigation of strategies aiming to reduce long-term exposure to JAK inhibitors while maintaining disease control.

Objective:

To demonstrate the superiority of a JAK inhibitor stopping strategy compared with standard maintenance therapy in terms of treatment safety, efficacy, and patient satisfaction in adults with ulcerative colitis in deep remission.

Study Design:

This is a phase IV, prospective, multicenter, open-label, randomized controlled trial. Adult patients with ulcerative colitis receiving a stable dose of tofacitinib, upadacitinib, or filgotinib for at least 12 months and achieving sustained steroid-free clinical, biological, and endoscopic remission for at least 6 months will be randomized to either treatment discontinuation or continuation of standard maintenance therapy. A total of 224 participants will be enrolled and followed for 104 weeks.

Primary Endpoint:

The primary endpoint is a composite outcome assessing treatment safety, efficacy, and patient satisfaction during the first 52 weeks after randomization. Patient satisfaction will be evaluated using the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4).

Secondary Endpoints:

Secondary outcomes include adverse events and serious adverse events, maintenance of remission, treatment satisfaction, quality of life, JAK inhibitor exposure, endoscopic outcomes, relapse rates, treatment success at Weeks 52 and 104, and identification of predictors of successful treatment discontinuation.

Expected Benefits:

Reducing exposure to JAK inhibitors may improve the overall safety profile by decreasing treatment-related adverse events while reducing treatment burden for patients with ulcerative colitis. This strategy could support a more individualized and potentially safer long-term management approach for patients in sustained deep remission.

研究类型

介入性

注册 (估计的)

224

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 法国
      • Amiens、法国
        • CHU Amiens-Picardie
        • 首席研究员：
          • MAthurin FUMERY
        • 接触：
      • Avignon、法国
        • Centre Hospitalier d'Avignon
        • 接触：
        • 首席研究员：
          • Alban BENEZECH
      • Besançon、法国
        • CHRU Besançon
        • 首席研究员：
          • Lucine VUITTON
        • 接触：
      • Bordeaux、法国
      • Clermont-Ferrand、法国
      • Lille、法国
      • Lyon、法国
        • HCL
      • Marseille、法国
        • AP-HM Hôpital Nord
        • 首席研究员：
          • Lucas GUILLO
        • 接触：
      • Montpellier、法国
        • CHU Montpellier
        • 首席研究员：
          • Romain ALTWEGG
        • 接触：
      • Nancy、法国
        • CHRU NANCY
        • 首席研究员：
          • Benedicte Caron
        • 接触：
      • Nantes、法国
      • Nice、法国
        • CHU NICE
        • 首席研究员：
          • Adrien Nicolau
        • 接触：
      • Nîmes、法国
        • CHU Nîmes
        • 首席研究员：
          • Ludovic CAILLO
        • 接触：
      • Paris、法国
        • Hôpital Bicêtre
        • 首席研究员：
          • Aurelien Amiot
        • 接触：
      • Paris、法国
        • Hopital Beaujon
        • 接触：
        • 首席研究员：
          • Alexandre NUZZO
      • Paris、法国
        • Hôpital Henri-Mondor
        • 首席研究员：
          • Mathieu Uzzan
        • 接触：
      • Paris、法国
      • Rennes、法国
      • Rouen、法国
      • Saint-Etienne、法国
      • Toulon、法国
      • Toulouse、法国
        • CHU Toulouse
        • 接触：
        • 首席研究员：
          • Cyrielle GILETTA

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Diagnosis of UC from at least 6 months according to clinical, endoscopic, histological and/or radiological criteria.
  2. Male or female age ≥ 18 years
  3. Currently treated by JAK inhibitor (tofacitinib, upadacitinib or filgotinib) for more than 12 months.
  4. Currently at a stable dose of tofacitinib (5mg or 10mg twice a day), upadacitinib (15mg or 30mg per day) or filgotinib (200mg per day) for 6 months.
  5. Clinical steroid free remission for at least 6 months, defined by a partial Mayo Score < 2, with no subscore > 1 and rectal bleeding (RB) subscore of 0 (annex 1).
  6. Endoscopic steroid free remission for at inclusion, defined by a Mayo endoscopic subscore = 0 (annex 1).
  7. Fecal calprotectin ≤ 150μg/g.
  8. Without known risk factors for venous thromboembolism (VTE).
  9. Without known risk factors for major adverse cardiovascular events (MACE).
  10. Without known risk factors for malignancy.
  11. For women of child-bearing potential (WOCBP), and for men with partners who are WOCBP, willingness to use appropriate and efficient contraception, as recommended when using JAK inhibitor treatment (notably upadacitinib), during all the experimental treatment and until at least 4 weeks after the end of the experimental treatment, according to SmPC and CTFG (Clinical Trials Facilitation and Coordination Group) recommendations.
  12. Patients able to understand information provide to them and to give written informed consent for study.
  13. Affiliation to a social security scheme.
  14. Good general health according to history and clinical examination.

Exclusion Criteria:

  1. Steroid use ≤ 6 months prior to enrolment.
  2. Currently treated by steroid, immunosuppressive agents or biologics.
  3. Pregnancy or planned pregnancy during the study.
  4. Breastfeeding.
  5. Non-compliant subject or inability to follow study protocol.
  6. Intolerance of JAK inhibitors (excipients included) or severe adverse event.
  7. Contraindications to using a JAK inhibitor (excipients included).
  8. Known risk factors for VTE.
  9. Known risk factors for MACE.
  10. Active neoplasia or history of malignant tumours less than 5 years old.
  11. Participation to another interventional study protocol (except for RIPH3 studies)
  12. Severe hepatic insufficiency.
  13. Severe to end-stage renal insufficiency.
  14. Active tuberculosis, serious infections such as septicemia or opportunistic infections.
  15. Absence or refusal of informed consent.
  16. People under guardianship, conservatorship, or judicial protection;
  17. People receiving psychiatric care;
  18. People who have been deprived of their liberty by judicial or administrative order
  19. People with difficulty understanding and/or cognitive disorder

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：护理标准
实验性的：STOP, treatment withdrawal
药品：treatment withdrawal
the patients will stop their treatment, as long as possible until symptom reappearance, if any

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.
大体时间：1 year
treatment safety, during the first 52 weeks of the follow-up.
1 year
The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.
大体时间：1 year
treatment efficacy, during the first 52 weeks of the follow-up.
1 year
The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.
大体时间：1 year
patient satisfaction during the first 52 weeks of the follow-up.
1 year

次要结果测量

结果测量
大体时间
Safety: occurrence of herpes zoster, infection, cardiovascular event, biochemical parameter, malignancies, adverse event leading to discontinuation, and all adverse events (serious or not) during the whole follow-up.
大体时间：2 years
2 years
Remission rate at the end the first 52 weeks of the follow-up
大体时间：1 year
1 year
Assess the treatment success of this innovative therapeutic strategy at the end of the first 52 weeks of the follow-up and after 104 weeks of follow-up.
大体时间：2 years
2 years
Partial Mayo score at each visit of the entire follow-up
大体时间：2 years
2 years
Number of days under treatment and cumulative dose of treatment per patient between randomization and primary endpoint
大体时间：1 year
1 year
Number of days under induction dose of JAK inhibitor at the end the first 52 weeks of the follow-up.
大体时间：1 year
1 year
Mayo endoscopic subscore at week 52 and week 104
大体时间：2 years
2 years
Proportion of patients relapsing for each arm
大体时间：2 years
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assistance Publique Hopitaux De Marseille

调查人员

  • 首席研究员：Lucas GUILLO, DR、AP-HM

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2030年1月1日

研究完成 (估计的)

2031年1月1日

研究注册日期

首次提交

2026年7月10日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RCAPHM24_0353 - STOP
  • 2026-525643-32-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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