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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

February 1, 2028

Study Completion Date

February 1, 2028

Conditions
Idiopathic Granulomatous Mastitis
Interventions
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.

Trial Locations (1)

119074

National University Hospital, Singapore

All Listed Sponsors
lead

National University Hospital, Singapore

OTHER