NCT06943482尚未招募4 期
A Pilot Open-label Randomised Trial Comparing the Effectiveness of Steroids and Methotrexate for the Treatment of Idiopathic Granulomatous Mastitis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieved clinical or radiological complete response by 6 months
研究概览
简要总结
This research study is to determine the effectiveness of prednisolone and methotrexate for IGM patients over a period of one year, in terms of clinical and radiological response. Recruitment will be conducted in National University Hospital (NUH) for patients diagnosed with IGM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, aged between 21 and 60 years
- •Positive diagnosis of idiopathic granulomatous mastitis based on histopathology results
- •Willing and able to give informed consent
- •Exclusion Criteria (Patients who meet any of the following prerequisites will not be allowed to take part in this study):
- •Women who are currently pregnant or breastfeeding
- •Cognitive impairment which prevents the patient from giving voluntary consent
- •History of any psychiatric conditions such as depression, psychosis, schizophrenia etc.
- •History of cancer in the past 5 years
- •History of abnormal renal or liver function
- •History of diabetes mellitus
- •History of pulmonary lung disease, pneumonitis, or related conditions
- •Hepatitis B and/or Hepatitis C carrier
- •Diagnosed with tuberculosis (Positive microbiological evaluation for Grocott Methenamine Silver stain and Ziehl- Neelsen stain)
- •Any immunosuppressants or anti-inflammatory medications such as NSAIDS for the past 3 months
- •Concomitant medication that may have contraindication with prednisolone and methotrexate use
- •Hypersensitivity to components or drug products of prednisolone and methotrexate
- •Vaccination with live virus vaccines prior to or during treatment
排除标准
- 未提供
研究组 & 干预措施
Steroid
Active Comparator
干预措施: Prednisolone (Drug)
Steroid
Active Comparator
干预措施: Omeprazole 20 mg (Drug)
Methotrexate
Experimental
干预措施: Methotrexate (Drug)
Methotrexate
Experimental
干预措施: Folic Acid 5 MG (Drug)
结局指标
主要结局
Proportion of patients who achieved clinical or radiological complete response by 6 months
时间窗: 6 months
Time to clinical response and time to radiological response
时间窗: 6 months
Proportion of patients with relapse in a year within affected breast between each arm.
时间窗: 1 year
次要结局
- Evaluation of side effects.(1 year)
- Evaluation of of treatment failure (TF) rate(6 months)
- Evaluation of frequency of percutaneous or surgical intervention required(6 months)
- Evaluation of potential unique pattern of gene expression that can be used to diagnose IGM and predict treatment response(3 years)
- Evaluation of potential biomarkers that may predict response to treatment: eg IL-6, CRP and neutrophil to lymphocyte ratio (NLR)(3 years)
- Evaluation of patient reported outcome measures(3 years)
- Validate survey instrument for IGM patients(3 years)
研究者
研究点 (1)
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