A Phase 4 interventional study of Prednisolone and Methotrexate in Idiopathic Granulomatous Mastitis, sponsored by National University Hospital, Singapore. Not yet recruiting at 1 site in Singapore. Open to female participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by National University Hospital, Singapore · Phase 4, Interventional, and Treatment
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.
22 studies on the registry are indexed under Granulomatous Mastitis; 7 are open to participants now.
This study's planned enrollment of 40 is below the median of 61 across 12 interventional studies indexed under Granulomatous Mastitis.
Browse Granulomatous Mastitis studies →National University Hospital, Singapore is the lead sponsor of 454 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria (Patients who meet any of the following prerequisites will not be allowed to take part in this study):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Prednisolone · Drug: Omeprazole 20 mg
Drug: Methotrexate · Drug: Folic Acid 5 MG
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.
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.
5mg of folic acid is to be taken together with methotrexate once a week.
Omeprazole will be prescribed at 20mg to protect the stomach lining.
Proportion of patients who achieved clinical or radiological complete response by 6 months
Time frame: 6 months
Time to clinical response and time to radiological response
Time frame: 6 months
Proportion of patients with relapse in a year within affected breast between each arm.
Time frame: 1 year
Evaluation of side effects.
Time frame: 1 year
Evaluation of of treatment failure (TF) rate
Time frame: 6 months
Evaluation of frequency of percutaneous or surgical intervention required
Time frame: 6 months
Evaluation of potential unique pattern of gene expression that can be used to diagnose IGM and predict treatment response
Time frame: 3 years
Evaluation of potential biomarkers that may predict response to treatment: eg IL-6, CRP and neutrophil to lymphocyte ratio (NLR)
Depending on the biomarkers tested, there will be different unit of measurements. Some examples of biomarkers that may be tested are: CRP: mg/l IL-6: pg/ml NLR: ratio
Time frame: 3 years
Evaluation of patient reported outcome measures
Most of our questions are on a scale from 1 - 5, with some yes or no question and an open question at the end.
Time frame: 3 years
Validate survey instrument for IGM patients
The survey is adopted from SF-36 for general health and EORTC BR23 for body image, breast health and pain.
Time frame: 3 years
Plan to share: No
Start is estimated for Jul 2025; primary completion for Feb 2028, 31 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methotrexate
National University Hospital, Singapore →