Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Condition(s) studied

Investigational drug(s) / intervention(s)

glucocorticoid plus iguratimod: 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).

glucocorticoid plus leflunomide: 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).

Study summary

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.

Eligibility

Primary outcome measure(s)

• The difference of relapse rate of IgG4-RD among 2 groups in 12 months. — 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.

Trial sites (1)

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