Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Conditions
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Autoimmune Diseases

Intervention / Treatment
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* Drug: Diprospan plus iguratimod
* Drug: Diprospan plus leflunomide
* Drug: Prednisone plus leflunomide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>Patients are treated with Diprospan (1mL im) and then with iguratimod (25mg bid) for 12 months | Drug: Diprospan plus iguratimod<br>* Patients are treated with Diprospan (1mL im) and then with iguratimod (25mg bid) for 12 months.<br>|
| Experimental: Group II<br>Patients are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd) for 12 months. | Drug: Diprospan plus leflunomide<br>* Patients are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd) for 12 months.<br>|
| Experimental: Group Ⅲ<br>Patients are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd) for 12 months. | Drug: Prednisone plus leflunomide<br>* Patients are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd) for 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of relapse rate of IgG4-RD among 3 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. | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunoglobulin G4-Related Disease, treatment strategies, iguratimod, leflunomide, relapse