NCT03843697Unknown不适用
A Controlled Trial for the Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease
Tahel Ilan Ber0 个研究点目标入组 20 人开始时间: 2019年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Proportion of subjects with reduction chron's disease activity index score more than 100 points during the study;
研究概览
简要总结
Trial for IBD patients non-responsive to biological drugs, using medical app reminding patients to take their physician-prescribed medications
详细描述
Patients with IBD who developed loss of response to anti-TNF based medications will receive a cell phone based app that will remind them to take the drug with an approved dosing range.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Diagnosis of CD or UC according to validated criteria, with a Crohn's Disease Activity Score (CDAI) of 200-450 at inclusion.
- •Patients on a stable dose within the last 6 weeks of any type of anti TNF agent or any other biological agent
- •5-ASA (mesalamine), and immunomodulatory, or immunosuppressive agent, and symptomatic relief (anti-diarrheals) for patients are allowed in a stable dose (6 weeks).
- •Non-smoking (by declaration) for a period of at least 6 months.
- •Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study.
- •No known history of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, primary hematopoietic disease, neoplasm, or any other clinically significant medical disorder other than Crohn's disease and its complications, which in the investigator's judgment contraindicate administration of the study medications.
- •No history of drug or alcohol abuse.
- •Screening tests must meet the following criteria: HGB ≥8.5 g/dL, platelets ≥ 100,000/ mm³, WBC: 3500-12,000/mm³, serum albumin above 2.5 g/dL, amylase, lipase and total bilirubin within normal limits. ALT, AST, alkaline phosphatase up to 1.5 times normal limits.
- •No clinically significant abnormalities in screening physical exam.
- •Negative HIV, Hepatitis B and Hepatitis C serology tests within 2 years.
- •Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Patients must satisfy a medical examiner about their fitness to participate in the study.
- •Patients must provide written informed consent to participate in the study.
排除标准
- •Patients with evidence of other serious infectious, autoimmune, hepatic, nephritic or systemic disease or compromised organ function.
- •Patients with a present colostomy, ileostomy or subtotal colectomy with ileorectal anastomosis.
- •Symptomatic stenosis or ileal strictures, x-ray evidence of fibrosed bowel.
- •Patients presenting with, or with a history of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed or abdominal abscess or infection, toxic megacolon.
- •Patients with fistulating CD.
- •Short bowel syndrome.
- •Patients with a history of GI tract malignancy or IBD-associated malignant changes in the intestines.
- •Patients with any clinically significant abnormality upon physical examination or in the clinical laboratory test values.
- •A change in the dose of the immunomodulatory or immunosuppressive drug within 6 weeks.
- •Over-the-counter drugs, including herbal medications, and prescription drugs (other than those listed above) are not allowed for 7 days prior to first study dosing and throughout the duration of the study
- •Receipt of packed RBC's within 3 months prior to the first study dosing and throughout the study.
- •Participation in another clinical trial within 30 days prior to first drug administration.
- •Patients with an inability to communicate well with the PI and staff (i.e., language problem, poor mental development or impaired cerebral function).
- •Patients with any acute medical situation (e.g. acute infection) within 48 hours of first dosing session, which is considered of significance by the Principal Investigator.
- •Patients who will be unavailable for the duration of the trial, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the PI for any other reason.
结局指标
主要结局
Proportion of subjects with reduction chron's disease activity index score more than 100 points during the study;
时间窗: 10 weeks
Proportion of subjects with reduction chron's disease activity index score more than 100 points during the study;
次要结局
- Proportion of subjects achieving clinical remission or response without steroid rescue therapy during the study;(10 weeks)
研究者
Tahel Ilan Ber
Chief Medical Officer
Oberon Sciences LTD
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