Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Peking Union Medical College Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Autoimmune Diseases

Interventions

glucocorticoid plus iguratimodDRUG

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 leflunomideDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Yunyun Fei, MD

CONTACT

01069159953 feiyunyun@pumch.cn

Data from ClinicalTrials.gov

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