NCT03261206进行中（未招募）4 期
Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 334
- 试验地点
- 92
- 主要终点
- CD-related complications at 2 years
研究概览
简要总结
The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.
详细描述
Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents for patients with Crohn's disease (CD) in remission. However, there is uncertainty regarding their effectiveness for CD.
In this open-label, randomized study, participants with CD in remission will be allocated to either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in maintaining CD remission over a 24 month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of CD at least 3 months prior to enrollment
- •Taking any brand or dosage of an oral aminosalicylate for at least 6 months
- •Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)
- •CD currently in clinical remission
- •Able to participate fully in all aspects of the clinical trial
- •Written informed consent obtained and documented
排除标准
- •A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis
- •A diagnosis of short-bowel syndrome
- •Active perianal disease
- •Active fistulizing disease
- •A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery
- •Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment
- •Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment
- •Unwillingness to stop taking aminosalicylates for the duration of the trial
- •Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment
- •Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
- •History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures
- •Currently participating in another interventional trial, or previous participation within the last 3 months
研究组 & 干预措施
5-ASA Withdrawal
Experimental
Half of the subjects will discontinue their aminosalicylate therapy
干预措施: 5-ASA Withdrawal (Other)
5-ASA Continuation
No Intervention
Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study
结局指标
主要结局
CD-related complications at 2 years
时间窗: 24 months
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
次要结局
- CD-related or CD-treatment related surgeries at 1 year(12 months)
- CD-related or CD-treatment related hospitalizations at 1 year(12 months)
- Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year(12 months)
- Time to first CD-related complication(up to 24 months)
- CD-related complications at 1 year(12 months)
- CD-related or CD-treatment related hospitalizations at 2 years(24 months)
- Other CD-related or CD-treatment related complications at 1 year(12 months)
- Other CD-related or CD-treatment related complications at 2 years(24 months)
- Change in self-assessed quality of life at 2 years(Base line and 24 months)
- Change in CD-related and total healthcare costs at 2 years(12 months prior to enrollment and 24 months after enrollment)
- Change in disease activity at 24 months(24 months)
- CD-related or CD-treatment related surgeries at 2 years(24 months)
- Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years(24 months)
- Change in self-assessed quality of life at 1 year(Base line and 12 months)
- Change in C-reactive protein concentration at 1 year(Base line and 12 months)
- Change in CD-related drug treatment costs at 2 years(12 months prior to enrollment and 24 months after enrollment)
- Change in disease activity at 6 months(6 months)
- Change in disease activity at 12 months(12 months)
- Change in self-assessed quality of life at 6 months(Base line and 6 months)
- Change in C-reactive protein concentration at 6 months(Base line and 6 months)
- Change in C-reactive protein concentration at 2 years(Base line and 24 months)
- Change in fecal calprotectin concentration at 2 years(Base line and 24 months)
- Change in fecal calprotectin concentration at 1 year(Base line and 12 months)
研究者
研究点 (92)
Loading locations...
相似试验
进行中（未招募）
1 期
An investigational study to assess the safety and effectiveness of continuing existing 5-ASA medication versus stopping it.Inactive Crohn’s DiseaseEUCTR2018-001382-17-GBAlimentiv Inc1,580
已完成
不适用
Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative ColitisColitis, UlcerativeAminosalicylic AcidNCT02537210Chinese University of Hong Kong177
进行中（未招募）
1 期
A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trialThe medical condition is Ulcerative Colitis.EUCTR2005-000695-40-GBniversity of Nottingham420
已完成
不适用
Low-dose Acetylsalicylic Acid Before Non-cardiac SurgerySurgeryPlatelet DysfunctionNCT03049566Universitätsklinikum Hamburg-Eppendorf805
已完成
不适用
Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's DiseaseCrohn's DiseaseNCT00004423University of Vermont80