NCT06523647招募中不适用
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components
Kazakhstan Scientific Society for Study of intestine diseases4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年6月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- The proportion of patients with a reduced level of disease activity by 30% or more according to the Crohn's Disease Activity Index
研究概览
简要总结
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients aged 18 years and older;
- •Patients who were first prescribed Ustekinumab between January 1 and December 31, 2024
- •Patients who provided written informed consent to participate in the study
排除标准
- •Contraindications to the use of the drug Ustekinumab per the current instructions:
- •Clinically significant active infection (active tuberculosis, active viral hepatitis);
- •Pregnancy and lactation;
- •A history of clinically significant, in the opinion of the investigator, psychiatric disorders that may interfere with the study procedures and compliance with the drug regimen;
- •Ulcerative colitis;
- •Malignant gastrointestinal diseases in history or at the time of inclusion in the study;
- •Decompensated chronic diseases of the liver, kidneys, cardiovascular system, systemic vasculitis, diabetes mellitus;
- •Abuse of alcohol or psychoactive drugs within 1 year before the start of this study (as reported by the patient);
- •Participation in an interventional clinical trial.
结局指标
主要结局
The proportion of patients with a reduced level of disease activity by 30% or more according to the Crohn's Disease Activity Index
时间窗: at week 24 of therapy
次要结局
- Dynamics of potassium parameters(at 24 and 52 weeks)
- Proportion of patients with a 30% or more reduction in disease activity according to the Crohn's Disease Activity Index(at 12 and 52 weeks of therapy)
- Collection of information on adverse reactions and/or registration of pregnancy cases(through study completion, an average of 1 year)
- Dynamics of quality of life assessment based on the Short Inflammatory Bowel Disease Questionnaire(at 12, 24 and 52 weeks)
- Dynamics of antibody synthesis to the drug Ustekinumab(at 0/1, 24 and 52 weeks)
- List of medications indicated in the general scheme with Odeston(through study completion, an average of 1 year)
- Dynamics of albumin parameters(at 24 and 52 weeks)
- Dynamics of serum iron parameters(at 24 and 52 weeks)
- Proportion of patients in endoscopic remission based on Simple Endoscopic Score for Crohn's Disease(at 24 and 52 weeks)
- Dynamics of fecal calprotectin levels(at 24 and 52 weeks)
- Proportion of patients with normalization of Magnetic resonance enterography based on the Magnetic Resonance Index of Activity(at 12 and 52 weeks)
- Dynamics of red blood cell parameters(at 24 and 52 weeks)
- Dynamics of vitamin B9 parameters(at 24 and 52 weeks)
- Dynamics of erythrocyte sedimentation rate parameters(at 24 and 52 weeks)
- Dynamics of C-reactive protein parameters(at 24 and 52 weeks)
- Dynamics of serum iron-binding capacity parameters(at 24 and 52 weeks)
- Dynamics of assessing patient adherence to treatment using the Morisky-Green scale(at 0/1, 12, 24 and 52 weeks)
- Dynamics of platelet parameters(at 24 and 52 weeks)
- Dynamics of total protein parameters(at 24 and 52 weeks)
- Dynamics of Nutritional Risk Index indicators(at 24 and 52 weeks)
- Dynamics of hemoglobin parameters(at 24 and 52 weeks)
- Dynamics of leukocyte parameters with leukocyte formula(at 24 and 52 weeks)
- Dynamics of sodium parameters(at 24 and 52 weeks)
研究者
研究点 (4)
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