To assess the efficacy, tolerability and change in quality of life among Ulcerative colitis patients who are taking Tofacitinib: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To calculate mayo score, UCEIS and True love and Witt score before starting the treatment and after giving 1 month of induction followed by 3 months of maintenance dose of tofacitinib, then compare the both values.
研究概览
简要总结
Ulcerative colitis was once considered to be a disease of the Western world, but the incidence among Asian people is increasing. Topical mesalamine and steroids are the main line of treatment for newly diagnosed Ulcerative colitis. In severe disease activity intravenous steroid, intravenous anti TNF alpha (infliximab/adalimumab) or intravenous cyclosporin are used. In May 30, 2018, FDA approved tofacitinib for the treatment of moderate to severely active ulcerative colitis. Tofacitinib is also orally available and is cost-effective. As it is not a monoclonal antibody, it is not antigenic. The purpose of this observational study is to evaluate the benefits, tolerability, efficacy and acceptance of tofacitinib in Indian Population. This study will also help to unfold any hinderance facing by the patient during its uses and assess the change in the quality of life among Ulcerative colitis patients who are taking Tofacitinib.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patient diagnosed with Ulcerative colitis
- •Patients giving willful consent for participation in the study.
排除标准
- •1.Patient taking steroid or other biological drugs
- •Pregnant and lactating women
- •Malignancy
- •Patients with Crohn’s disease, microscopic colitis, and celiac disease
- •Patients with uncertain diagnosis
- •Patient unwilling to participate in study
- •Myocardial infarction (within previous 3 months)/Heart failure
- •Use of combined hormonal contraceptives or hormone replacement therapy
- •Patient with uncontrolled diabetes, uncontrolled hypertension.
结局指标
主要结局
To calculate mayo score, UCEIS and True love and Witt score before starting the treatment and after giving 1 month of induction followed by 3 months of maintenance dose of tofacitinib, then compare the both values.
时间窗: 1 month of induction followed by 3 months of maintenance therapy with tab Tofacitinib.
次要结局
- (1) to measure any bleeding episodes- Hematochezia during the treatment period - 4 months from initiation of treatment((2) Any hospital admission & duration of hospital stay during during the treatment period)
研究者
Leo Angom Mani
PGIMER, Chandigarh