ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Endoscopic remission
研究概览
简要总结
For the last years the aim of the management of ulcerative colitis (UC) has become more ambitious including not only clinical remission but also the achievement of biological remission, endoscopic and histological healing, which are associated with less flares, hospitalizations and surgeries. About 50% of the patients with UC followed in routine are treated by 5-aminosalicylate acid (5-ASA) (oral and/or topical). The aim of the study is to describe the different levels of remission (clinical, endoscopic, histological) in UC patients treated only by 5-ASA, that report to be in clinical remission during a routine follow-up visit. The factors associated with different levels of remission (demographic, 5-ASA regimen, biologic, endoscopic, histologic) will be studied. Adherence and quality of life will be examined through patient questionnaires.
详细描述
The management of inflammatory bowel diseases aims to induce not only a clinical corticosteroid-free remission but also a deep remission defined by the achievement of mucosal healing. In ulcerative colitis (UC), mucosal healing has been nicely correlated with a better outcome of the disease. A lack of mucosal healing after a first steroid course is associated with a bad outcome including higher hospitalizations and more clinical relapses after 1 year. The absence of mucosal healing has also been correlated with higher rates of colectomy. Mucosal healing is defined by the absence of ulcers and includes patients with an endoscopic Mayo subscore of zero and one. Recently, a significantly better outcome has been demonstrated in patients having an endoscopic Mayo subscore of zero instead of one as well as a histological healing on the biopsies. The fecal biomarkers, especially the fecal calprotectin, have a high accuracy for the prediction of ongoing endoscopic and histologic inflammation in patients in clinical remission. Fecal calprotectin is well correlated with the Mayo endoscopic subscore and can discriminate patients with an endoscopic Mayo subscore of zero versus one or more by using a cut-off of 150 microgram/gram. A residual histologic inflammation is associated with a fecal calprotectin of 155 microgram/gram or more. Subsequently the management of UC has evolved and aims to induce a tighter control of the disease including a complete endoscopic response and a histological healing. It is currently not known how well these patients who report being in clinical remission are actually in objectively defined remission. As a deep remission is so important for the future evaluation of the disease, it is important to understand the factors linked to the absence of such remission.
The primary objective of this study is to describe the percentage of the different levels of remission (clinical, endoscopic, histological), in UC patients, treated by 5-ASA for at least 6 months, free of concomitant UC medications for at least 3 months and presenting for a routine follow-up visit.
The secondary objectives of this study are:
- to identify the factors associated to the absence of deep remission (demographic, UC history, clinical, biological, endoscopic, histological, 5-ASA regimen, adherence)
- to describe the adherence of the patients to the 5-ASA medications and its impact on the remission status.
- to describe the regimen of 5-ASA prescription (dosage, oral/local form) and its impact on the remission status.
- to describe the quality of life of the patients with UC on 5-ASA and its correlation with the level of remission.
- to understand the implication of patient's perspective and physician's perspective in patient lacking deep remission.
- to analyze the reasons of non-deep remission
This study is a national, multicenter, transversal, interventional study conducted in Belgium (16 centers will participate). The trial design is as follows:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years
- •Confirmed diagnosis of UC
- •Patients with PRO-2 ≤ 1, with ≤ 1 for stool frequency and 0 for rectal bleeding in the last 3 days before the visit.
- •Recruitment during a routine follow-up visit.
- •Subjects to whom 5-ASA treatment has been prescribed for at least 6 months (any type of oral and/or rectal 5 ASA, any dosage) and with the dose of 5-ASA stable for at least 2 weeks (including suppositories) prior to inclusion.
- •Prescription of 5-ASA is within the locally approved Summary of Product Characteristics (SmPCs)
- •Subjects free of concomitant UC medication (corticosteroids, immunomodulators, biologics, JAK inhibitors, S1PR modulator or investigational drugs) for at least 3 months
- •Subject or the subject's legally acceptable representative have the capacity to understand and (voluntary) sign an informed consent form
- •Be able to adhere to the study visit schedule and other protocol requirements
排除标准
- •Any subject who meets one of the following criteria will not qualify for entry in the study:
- •Subjects currently treated by immunomodulators, biologics, JAK inhibitors, S1PR modulator and investigational drugs and within the last three months. A history of immunomodulator or biologic or JAK inhibitor or S1PR modulator and investigational drugs use in the past is not an exclusion criteria.
- •Subjects recruited during hospitalization, or via the urgency department for active UC, or during an unscheduled visit for emergency reasons.
- •UC patients with a total colectomy, with or without IPAA
- •Patients with indetermined colitis (IBDU)
- •Women that are pregnant
研究组 & 干预措施
UC patients
UC patients, treated by 5-ASA for at least 6 months, free of concomitant UC medications for at least 3 months and presenting for a routine follow-up visit
干预措施: 5-ASA (Drug)
结局指标
主要结局
Endoscopic remission
时间窗: week 0
Endoscopic remission is defined by an endoscopic MAYO subscore of 0 or 1 and/or by a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) of 0 or 1
Complete clinical remission
时间窗: week 0
Complete clinical remission is defined by a PRO-2 = 0 and no bowel urgency
Histological remission
时间窗: week 0
Histological remission will be defined by the absence of any acute inflammatory activity on the biopsies according to the Geboes score, including Geboes 0-1
Deep remission
时间窗: week 0
Deep remission will be defined by the combination of complete clinical, complete endoscopic and histological remission
次要结局
- Disease activity based on PRO-2 score associated to the absence of deep remission(week 0)
- Disease activity based on bowel urgency associated to the absence of deep remission(week 0)
- The percentage of prescription of the different 5-ASA regimens(week 0)
- Demographic factors associated to the absence of deep remission(week 0)
- Disease characteristics associated to the absence of deep remission(week 0)
- Medical history associated to the absence of deep remission(week 0)
- Disease activity based on histological Geboes score associated to the absence of deep remission(week 0)
- The impact of the prescription rate of the different 5-ASA regimens on the remission status(week 0)
- Medication history associated to the absence of deep remission(week 0)
- Disease activity based on endoscopic score associated to the absence of deep remission(week 0)
- Disease activity based on objective markers associated to the absence of deep remission(week 0)
- Adherence associated to the absence of deep remission(week 0)
- The percentage of adherent patients on 5-ASA medications(week 0)
- The impact of adherence on the remission status(week 0)
- Quantification of the quality of life of the patients with UC on 5-ASA(week 0)
- Correlation of the quality of life scores with the level of remission(week 0)
- The factors associated with non-deep remission coming from either physician management or patient perception(week 0)