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NCT06943482 | NOT YET RECRUITING | Idiopathic Granulomatous Mastitis

Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease
Sponsor:

National University Hospital, Singapore

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 conducted in National University Hospital (NUH) for patients diagnosed with IGM.

Condition or disease

Idiopathic Granulomatous Mastitis

Intervention/treatment

Prednisolone

Methotrexate

Folic Acid 5 MG

Omeprazole 20 mg

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Pilot Open-label Randomised Trial Comparing the Effectiveness of Steroids and Methotrexate for the Treatment of Idiopathic Granulomatous Mastitis
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2028-02-01
Estimated Study Completion Date : 2028-02-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 60 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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
Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease

Location Details

NCT06943482

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How to Participate

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Locations

Not yet recruiting

Singapore,

National University Hospital

Singapore, Singapore, 119074