Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05789030

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Diseases	Drug: Diprospan plus iguratimod Drug: Diprospan plus leflunomide Drug: Prednisone plus leflunomide	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Group I

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

Drug: Diprospan plus iguratimod

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

Experimental: Group II

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

Drug: Diprospan plus leflunomide

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

Experimental: Group Ⅲ

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

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

Outcome Measures

Primary Outcome Measures

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

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
The difference of the response rate of the treatment among the 3 groups. [12 months]
Complete response rate; Partial response rate; No response
Side effects [12 months]
Any side effects caused by treatments for IgG4-RD.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.