Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

NCT ID: NCT05789030

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-12-30

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.

Conditions

Autoimmune Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I

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

Group Type: EXPERIMENTAL

Diprospan plus iguratimod

Intervention Type: DRUG

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

Group II

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

Group Type: EXPERIMENTAL

Diprospan plus leflunomide

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Prednisone plus leflunomide

Intervention Type: DRUG

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

Interventions

Diprospan plus iguratimod

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

Intervention Type: DRUG

Diprospan plus leflunomide

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wen Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wen Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunyun Fei, MD

Role: CONTACT

feiyunyun@pumch.cn

01069159953

Facility Contacts

Yunyun Fei, MD

Role: primary

feiyunyun@pumch.cn

01069159953

Other Identifiers

IgG4-RD, superficial organ

Identifier Type: -

Identifier Source: org_study_id