Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Autoimmune Diseases

Treatments: Drug: Prednisone plus leflunomide; Drug: Diprospan plus leflunomide; Drug: Diprospan plus iguratimod

Study type: Interventional

Funder types: Other

Identifiers

NCT05789030

IgG4-RD, superficial organ

Details and patient eligibility

About

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 three treatment strategies in IgG4-RD patients with superficial organ involvement: Diprospan plus iguratimod, Diprospan plus leflunomide and prednisone plus leflunomide.

Full description

90 IgG4-RD patients with superficial organ involvement are enrolled in this study and randomly divided into three groups at a 1:1:1 ratio: patients in group I are treated with Diprospan (1mL im) and then with iguratimod (25mg bid); patients in group Ⅱ are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd); and patients in group Ⅲ are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group I

Experimental group

Description:

Patients are treated with Diprospan (1mL im) and then with iguratimod (25mg bid) for 12 months

Treatment:

Drug: Diprospan plus iguratimod

Group II

Experimental group

Description:

Patients are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd) for 12 months.

Treatment:

Drug: Diprospan plus leflunomide

Group Ⅲ

Experimental group

Description:

Patients are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd) for 12 months.

Treatment:

Drug: Prednisone plus leflunomide