Comparing treatment strategies for IgG4-RD patients with internal organ involvement
Efficacy of Mycophenolate Mofetil Versus Leflunomide as Maintenance Treatment for IgG4-RD Patients With Internal Organ Involvement
This study is testing two different treatment plans to see which one helps people with IgG4-related disease and internal organ issues stay in remission longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05789017 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to evaluate the efficacy and safety of two treatment strategies for patients with active IgG4-related disease (IgG4-RD) who have internal organ involvement. A total of 60 patients will first receive a combination of glucocorticoids and mycophenolate mofetil during a 6-month remission induction period. Following this, patients will be randomly assigned to either a low dose of mycophenolate mofetil or leflunomide for an additional 12 months, during which their relapse rates and other clinical outcomes will be monitored. The primary goal is to determine the difference in relapse rates between the two treatment groups at the end of the study period.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with active IgG4-RD who require glucocorticoid treatment and meet the ACR/EULAR classification criteria.
Not a fit: Patients with other autoimmune diseases, malignancies, or severe irreversible organ damage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for managing IgG4-RD and reducing relapse rates in affected patients.
How similar studies have performed: While there have been studies on treatment strategies for IgG4-RD, this specific comparison of low dose mycophenolate mofetil and leflunomide is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria; 2. Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment. Exclusion Criteria: * 1\. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women； 4. Active infection: HIV, HCV, HBV, TB； 5. Severe irreversible damage of organ function; 6. Receipt of any biologic therapy or immunosuppressive agent other than GCs.
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Wen Zhang, MD — Peking Union Medical College Hospital
- Study coordinator: Yunyun Fei, MD
- Email: feiyunyun@pumch.cn
- Phone: 01069159953
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.