Prednisone plus iguratimod versus prednisone plus leflunomide for IgG4‑RD with superficial organ involvement
Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement
NA · Peking Union Medical College Hospital · NCT05789030
This 12‑month trial will test whether adding iguratimod or leflunomide to prednisone better prevents relapse in people with IgG4‑related disease affecting superficial organs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital (other) |
| Drugs / interventions | prednisone |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05789030 on ClinicalTrials.gov |
What this trial studies
This 12‑month open‑label randomized controlled trial will enroll 60 patients with IgG4‑related disease involving superficial organs and randomize them 1:1 to two treatment arms. One group receives prednisone tapered to ≤5 mg within three months plus iguratimod 25 mg twice daily, and the other receives the same prednisone taper plus leflunomide 10–20 mg once daily. Participants are followed with clinical evaluations, laboratory tests, imaging, and the IgG4‑RD Responder Index to monitor response and safety. The primary outcome is the difference in relapse rate at 12 months, with secondary outcomes including time to relapse, response rate, and side effects.
Who should consider this trial
Good fit: Adults who meet the 2019 ACR/EULAR criteria for IgG4‑RD, have superficial organ involvement, require glucocorticoid treatment, and meet the trial's infection, malignancy, pregnancy, and medication restrictions are ideal candidates.
Not a fit: Patients with other autoimmune or malignant diseases, active infections (HIV, HBV, HCV, TB), pregnant or lactating women, those with severe irreversible organ damage, or prior biologic/immunosuppressant use are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If one combination reduces relapses with acceptable safety, patients could experience longer remission and reduced steroid exposure.
How similar studies have performed: While conventional immunosuppressants like leflunomide have some supportive case series and observational data in IgG4‑RD, randomized comparisons between iguratimod and leflunomide for this condition are limited.
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; 3. The addition of glucocorticoids was started at lower than 10 mg/d. 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.
Conditions: Autoimmune Diseases, Immunoglobulin G4-Related Disease, treatment strategies, iguratimod, leflunomide, relapse