Status:
NOT_YET_RECRUITING
Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Idiopathic Granulomatous Mastitis
Eligibility:
FEMALE
21-60 years
Phase:
PHASE4
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06943482
Start Date
July 1 2025
End Date
February 1 2028
Last Update
April 24 2025
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119074