Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in surface CTLA4 expression
研究概览
简要总结
The objective of this study is to assess the efficacy of hydroxychloroquine (HCQ) when combined with Mesalamine in reducing clinical and histologic disease activity in patients who have active mild to severe Ulcerative Colitis (UC) and also to assess the immunological effects of hydroxychloroquine in this population. These outcomes will be evaluated both clinically and experimentally. In vitro, flow cytometry will be employed to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with HCQ, and then at the end of a 4 month follow up period. Suppression assays will be used to determine the functional capacity of the patient derived Tregs. Clinically, patients will be monitored for remission as defined by reduction in patient reported stool frequency and rectal bleeding (mayo sub-score 0 or 1) and endoscopically, by improvement in mucosal appearance (mayo sub-score 0 or 1), all objective measures in the mayo score.
详细描述
This is a single arm study to evaluate the efficacy and immunological effect of administering Hydroxychloroquine to patients of non-European ancestry who have active mild to severe Ulcerative Colitis in spite of Mesalamine therapy. 10 Participants will be recruited in Icahn School of Medicine at Mount Sinai and 10 in Emory University (20 across all sites).
Participants 18 years and above who identify as an individual of non-European ancestry with a diagnosis of Ulcerative Colitis will be approached for the study. Participants will be recruited from Mount Sinai IBD center prior to their standard of care endoscopy. Participants who meet the study's inclusion criteria i.e. If they currently have active disease, they will be able to receive the research medication.
Participants will be administered 400mg hydroxychloroquine tablets orally for four months in addition to Mesalamine. Pre and post medication clinical, endoscopic and immunological assessments will be compared. Participants will also be followed up with bi-monthly phone calls. Participants will have a post medication colonoscopy at the end of the 4 month period.
There is a risk of retinopathy and cardiomyopathy associated with long term use of the study drug at doses greater than 6.5mg/kg for more than 5 years. Participants will be screened for existing eye and heart disease and monitored pre and post medication for any new adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The gastroenterologist who will review pre- and post-intervention endoscopy and pathology reports will be masked to any and all information about the study participants including disease severity and medication.
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
- •Clinical diagnosis of mild to severe active Ulcerative Colitis (confirmed by endoscopy at screening),
- •Currently taking mesalamine,
- •Be an individual of non-European ancestry.
- •Adult 18 years and older
- •Exclusion Criteria
- •Current use of biologics, steroids or other UC medications not including mesalamine.
- •Presence of hepatic or renal insufficiency
- •Pregnancy or lactation
- •Known allergic reactions to components of the Hydroxychloroquine, Chloroquine or quinine products.
- •Any pre-existing macular disease or cardiac disease.
- •Treatment with another investigational drug or other intervention within 4 weeks.
排除标准
- 未提供
研究组 & 干预措施
Mesalamine and Hydroxychloroquine
All participants will be on Mesalamine and Hydroxychloroquine
干预措施: Mesalamine (Drug)
Mesalamine and Hydroxychloroquine
All participants will be on Mesalamine and Hydroxychloroquine
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Change in surface CTLA4 expression
时间窗: baseline and 4 months
Flow cytometry will be used to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with Hydroxychloroquine, and then at the end of a 4 month follow up period.
次要结局
- Change in Endoscopy Mayo Score(baseline and 4 months)
- Change in Partial Mayo Score(baseline and 4 months)
研究者
Judy Cho
Dean of Translational Genetics, Director, The Charles Bronfman Institute for Personalized Medicine
Icahn School of Medicine at Mount Sinai