Comparing glucocorticoids alone versus with MMF for IgG4-related disease
Comparison of Short-term Glucocorticoid Monotherapy and Short-term Glucocorticoid Combined with Mycophenolate Mofetil in the Treatment of IgG4 Related Disease
This study is testing whether adding a medication called Mycophenolate mofetil to glucocorticoids helps people with IgG4-related disease feel better compared to just using glucocorticoids alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06663618 on ClinicalTrials.gov |
What this trial studies
This study is a monocenter, 72-week prospective, randomized controlled trial that aims to compare the effectiveness of short-term glucocorticoid monotherapy against a combination of short-term glucocorticoids and Mycophenolate mofetil (MMF) in treating IgG4-related disease. Patients aged 18 to 80 who meet specific diagnostic criteria for IgG4-RD will be enrolled, and their responses to the two treatment regimens will be evaluated over the study period. The goal is to determine if the combination therapy offers any advantages over glucocorticoid monotherapy in managing this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 diagnosed with active IgG4-related disease.
Not a fit: Patients with other autoimmune diseases, severe organ complications, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with IgG4-related disease.
How similar studies have performed: Other studies have explored glucocorticoid treatments for autoimmune diseases, but this specific combination approach for IgG4-RD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-80 years old; 2. All patients must meet the comprehensive diagnostic criteria of IgG4-RD revised in Japan in 2020 or the classification criteria of IgG4-RD formulated by ACR/EULAR in 2019; 3. Active IgG4-RD (at least one organ has an IgG4-RD reaction score \>=2 at the time of enrollment.)； 4. No previous medication or recurrence after withdrawal. Exclusion Criteria: 1. Combined with other autoimmune diseases as the main diagnosis. 2. Pregnant or lactating women 3. Patients with malignant tumor 4. Active bacterial, fungal, viral or mycobacterial infections. 5. Severe complications of important organs, and the expected survival time is less than 6 months.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Wen Zhang, MD — Peking Union Medical College Hospital
- Study coordinator: Linyi Peng, MD
- Email: drpenglinyi@163.com
- Phone: 8615810395901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.