Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Not Applicable

Recruiting

• Conditions: Autoimmune Diseases
• Interventions: Drug: Prednisone plus leflunomide; Drug: Diprospan plus leflunomide; Drug: Diprospan plus iguratimod

• Registration Number: NCT05789030
• Lead Sponsor: Peking Union Medical College Hospital

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

Detailed 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.

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Last Update Submitted: 2023-03-16
• Study First Posted: 2023-03-29
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Ⅲ	Prednisone plus leflunomide	Patients are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd) for 12 months.
Group II	Diprospan plus leflunomide	Patients are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd) for 12 months.
Group I	Diprospan plus iguratimod	Patients are treated with Diprospan (1mL im) and then with iguratimod (25mg bid) for 12 months

Primary Outcome Measures

Name	Time	Method
The difference of relapse rate of IgG4-RD among 3 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.

Secondary Outcome Measures

Name	Time	Method
The difference of the time at baseline to first relapse among 3 groups	12 months	The difference of The difference of relapse time in 3 groups
Side effects	12 months	Any side effects caused by treatments for IgG4-RD.
The difference of the response rate of the treatment among the 3 groups.	12 months	Complete response rate; Partial response rate; No response

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China