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

April 16, 2025 updated by: National University Hospital, Singapore

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methotrexate
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.
Active Comparator: Steroid
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: Omeprazole 20 mg
Omeprazole will be prescribed at 20mg to protect the stomach lining.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who achieved clinical or radiological complete response by 6 months
Time Frame: 6 months
6 months
Time to clinical response and time to radiological response
Time Frame: 6 months
6 months
Proportion of patients with relapse in a year within affected breast between each arm.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of side effects.
Time Frame: 1 year
1 year
Evaluation of of treatment failure (TF) rate
Time Frame: 6 months
6 months
Evaluation of frequency of percutaneous or surgical intervention required
Time Frame: 6 months
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
3 years
Evaluation of potential biomarkers that may predict response to treatment: eg IL-6, CRP and neutrophil to lymphocyte ratio (NLR)
Time Frame: 3 years

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
3 years
Evaluation of patient reported outcome measures
Time Frame: 3 years
Most of our questions are on a scale from 1 - 5, with some yes or no question and an open question at the end.
3 years
Validate survey instrument for IGM patients
Time Frame: 3 years
The survey is adopted from SF-36 for general health and EORTC BR23 for body image, breast health and pain.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Serene Si Ning Goh, MBBS, National

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/00773

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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