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Steroids vs Methotrexate for Idiopathic Granulomatous Mastitis
NCT06943482Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Jul 2025
- Primary completion
- Feb 2028
- Countries
- 1
- Sponsor
- National University Hospital
- Modality
- Orthosteric Ligands
- Drugs
- methotrexate
- Conditions
- idiopathic granulomatous mastitis (IGM)
01
Overview
Phase 4, randomised, open-label trial of methotrexate in idiopathic granulomatous mastitis (IGM) (2 arms), sponsored by National University Hospital. Primary endpoints: Proportion of patients who achieved clinical or radiological complete response at 6 months, Time to clinical response and time to radiological response at 6 months and 1 more. Planned start Jul 2025; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Steroid Arm
Prednisolone tapering regimen + Omeprazole
Methotrexate Arm
Methotrexate weekly escalating regimen + Folic Acid
03
Who it enrols
Women aged 21-60 with histologically confirmed idiopathic granulomatous mastitis, excluding those with pregnancy, breastfeeding, recent cancer, diabetes, or active infections like TB or Hepatitis.
04
Endpoints
Primary
Proportion of patients who achieved clinical or radiological complete response
Time to clinical response and time to radiological response
Proportion of patients with relapse in a year within affected breast
Secondary
Evaluation of side effects
Evaluation of treatment failure (TF) rate
Evaluation of frequency of percutaneous or surgical intervention required
Evaluation of potential unique pattern of gene expression
Evaluation of potential biomarkers that may predict response to treatment
Evaluation of patient reported outcome measures
Validate survey instrument for IGM patients
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