Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

Peking Union Medical College Hospital60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Autoimmune Diseases

Interventions

Prednisone and Mycophenolate MofetilDRUG

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.

Mycophenolate MofetilDRUG

Patients are treated with low dose mycophenolate (1-1.5g/day) during remission maintenance period for 12 months.

LeflunomideDRUG

Patients are treated with leflunomide (20 mg/day) during remission maintenance period for 12 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

The difference of relapse rate of IgG4-RD between two groups in 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.

Time frame: 18 months

Secondary Outcomes

The difference of the time at baseline to first relapse between two groups.

Time frame: 18 months

Response rate to the treatment of the two groups.

Complete response rate; Partial response rate; No response

Time frame: 18 months

Side effects

Any side effects caused by treatments for IgG4-RD.

Time frame: 18 months

Central Contacts

Yunyun Fei, MD

CONTACT

01069159953 feiyunyun@pumch.cn

Data from ClinicalTrials.gov

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