Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission (UC-GOL)
Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis
This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14.
At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.
Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.
研究概览
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
MI
-
Rozzano、MI、意大利、20089
- 招聘中
- IBD Center
-
接触：
- Silvio Danese, MD, PhD
- 电话号码：5555 0039028224
- 邮箱：sdanese@hotmail.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients aged 18-65 years
- ability to understand the study procedures and sign the informed consent
- ulcerative colitis diagnosed at least 6 months before
- no previous exposure to anti-TNFs
- Global Mayo score ≥ 6 (with endoscopic sub-score ≥2) at baseline
- steroid-dependent disease
- women of childbearing potential must accept effective contraception during study participation and for at leas 6 months after the end of study participation
Exclusion Criteria:
- Crohn's disease or undetermined colitis
- active infections or previous infections not completely resolved at baseline
- malignancies in the previous 5 years
- suspected latent tuberculosis infection
- every other potentially harmful clinical condition, in the opinion of the investigator
- patients with moderately to severe heart failure (NYHA class III/IV)
- hepatic or renal failure
- pregnant or lactating women or women planning a pregnancy between baseline and the 3 months after study completion
- not permitted concomitant medications
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Golimumab
Subcutaneous golimumab
|
Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2) Maintenance regimen:
其他名称：
|
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 |
|---|---|---|
|
clinical and endoscopic steroid-free remission
大体时间：week 16
|
Total Mayo score ≤2, with no sub-score >1.
No concomitant corticosteroid therapy.
|
week 16
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
clinical response
大体时间：week 16
|
Decrease in total Mayo score of at least 2 point and 30 %
|
week 16
|
|
percentage of patients in clinical and endoscopic remission
大体时间：week 52
|
Total Mayo score ≤2, with no sub-score >1
|
week 52
|
|
percentage of patients in clinical remission
大体时间：week 52
|
partial Mayo score ≤2, with no sub-score >1
|
week 52
|
|
percentage of patients with mucosal healing
大体时间：week 16 and 52
|
complete mucosal healing: endoscopic sub-score 0
|
week 16 and 52
|
|
percentage of patients with histological healing
大体时间：week 16 and 52
|
histological healing: Geboes score <3 and no Mayo sub-score >1
|
week 16 and 52
|
|
quality of life
大体时间：week 16 and 52
|
IBDQ questionnaire
|
week 16 and 52
|
|
percentage of infliximab responders
大体时间：week 52
|
week 52
|
|
|
identification of patients that would benefit from golimumab therapy
大体时间：through week 52
|
evaluation of baseline characteristics of patients to identify potential response-predictive factors.
|
through week 52
|
合作者和调查者
调查人员
- 学习椅：Silvio Danese, MD, PhD、IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.