Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast … (NCT06943482) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease
Singapore40 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range
21 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients who achieved clinical or radiological complete response by 6 months
Timeframe: 6 months
2
Time to clinical response and time to radiological response
Timeframe: 6 months
3
Proportion of patients with relapse in a year within affected breast between each arm.