NCT06943482

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

A Pilot Open-label Randomised Trial Comparing the Effectiveness of Steroids and Methotrexate for the Treatment of Idiopathic Granulomatous Mastitis

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Granulomatous Mastitis

Interventions

Type	Name	Description
DRUG	Prednisolone	20mg of prednisolone will be prescribed, taken orally, and daily for first month followed by tapering doses of 15mg over one month, then 12.5mg for one month, proceeding to 10mg for one month, subsequently taking 7.5mg for one month, and lastly 5mg for one month.
DRUG	Methotrexate	10mg of methotrexate will be prescribed to be taken once a week for one month. The dosage will be increased to 15mg of methotrexate taken once a week on the 1st (T1) month clinical visit and will be further increased to 20mg of methotrexate taken once a week on the 2nd (T2) month clinical visit. There will be no further escalation of dosage after this visit.
DRUG	Folic Acid 5 MG	5mg of folic acid is to be taken together with methotrexate once a week.
DRUG	Omeprazole 20 mg	Omeprazole will be prescribed at 20mg to protect the stomach lining.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

1 site across 1 country: Singapore