An interventional study of glucocorticoid plus iguratimod and glucocorticoid plus leflunomide in Autoimmune Diseases, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
This study has been designed as a 12-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with superficial organ involvement: prednisone plus iguratimod and prednisone plus leflunomide.
60 IgG4-RD patients with superficial organ involvement are enrolled in this study and randomly divided into two groups at a 1:1 ratio: Patients in Group I are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≤5mg in 3 months) and iguratimod (25 mg bid). Patients in Group II are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≤5mg in 3 months ) and leflunomide (10-20 mg qd).All patients will be followed up for 12 months, and clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded during follow up. The primary endpoint is the difference of relapse rate between two groups at 12 months. The secondary endpoints are relapse time, response rate and side effects.
655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 427 interventional studies indexed under Autoimmune Diseases.
Browse Autoimmune Diseases studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months) and iguratimod (25 mg bid).
Drug: glucocorticoid plus iguratimod
Patients are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months ) and leflunomide (10-20 mg qd).
Drug: glucocorticoid plus leflunomide
Patients in Group I are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months) and iguratimod (25 mg bid).
Patients in Group II are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months ) and leflunomide (10-20 mg qd).
The difference of relapse rate of IgG4-RD among 2 groups in 12 months.
The definition of relapse: elevation of IgG4-RD Responder Index ≥ 2 points; new organ involvement or recurrence, with or without elevation of serum IgG4 levels.
Time frame: 12 months
The difference of the time at baseline to first relapse among 2 groups
The difference of relapse time in 2 groups
Time frame: 12 months
The difference of the response rate of the treatment among the 2 groups.
Complete response rate; Partial response rate; No response
Time frame: 12 months
Side effects
Any side effects caused by treatments for IgG4-RD.
Time frame: 12 months
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Peking Union Medical College Hospital