Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Autoimmune Diseases Clinical Trial

Official title:

Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05789030
• Other study ID #: IgG4-RD, superficial organ
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: Yunyun Fei, MD
• Phone: 01069159953
• Email: feiyunyun[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

Drug:
• Diprospan plus iguratimod
Patients are treated with Diprospan (1mL im) and then with iguratimod (25mg bid) for 12 months.
• Diprospan plus leflunomide
Patients are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd) for 12 months.
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The difference of the response rate of the treatment among the 3 groups.	Complete response rate; Partial response rate; No response	12 months
Secondary	Side effects	Any side effects caused by treatments for IgG4-RD.	12 months