Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

Not Applicable

Recruiting

• Conditions: Autoimmune Diseases
• Interventions: Drug: Prednisone and Mycophenolate Mofetil; Drug: Mycophenolate Mofetil; Drug: Leflunomide

• Registration Number: NCT05789017
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This study has been designed as a 18-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in active IgG4-RD patients with internal organ involvement during maintenance remission period: low dose mycophenolate mofetil group and leflunomide group.

Detailed Description

60 active IgG4-RD patients with internal organ involvement are enrolled in this study and accept the combination treatment of glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months. During remission maintenance period, pateints are randomly divided into two groups at a 1:1 ratio: patients in group I are treated with low dose mycophenolate mofetil (1-1.5g/day) and patients in group Ⅱ accept the treatment of leflunomide (20 mg/day). Patients in two groups will be followed up for another 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 18 months. The secondary endpoints are relapse time, response rate and side effects.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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 I	Prednisone and Mycophenolate Mofetil	Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months. Afterwards, patients are treated with low dose mycophenolate (1-1.5g/day) during remission maintenance period for 12 months.
Group II	Prednisone and Mycophenolate Mofetil	Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months. Afterwards, patients are treated with leflunomide (20 mg/day) during remission maintenance period for 12 months.
Group I	Mycophenolate Mofetil	Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months. Afterwards, patients are treated with low dose mycophenolate (1-1.5g/day) during remission maintenance period for 12 months.
Group II	Leflunomide	Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months. Afterwards, patients are treated with leflunomide (20 mg/day) during remission maintenance period for 12 months.

Primary Outcome Measures

Name	Time	Method
The difference of relapse rate of IgG4-RD between two groups in 18 months.	18 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 between two groups.	18 months
Side effects	18 months	Any side effects caused by treatments for IgG4-RD.
Response rate to the treatment of the two groups.	18 months	Complete response rate; Partial response rate; No response

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China