Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

NCT ID: NCT05789017

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-12-31

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.

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 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 Type: EXPERIMENTAL

Prednisone and Mycophenolate Mofetil

Intervention Type: DRUG

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 Mofetil

Intervention Type: DRUG

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

Group II

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 Type: EXPERIMENTAL

Prednisone and Mycophenolate Mofetil

Intervention Type: DRUG

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.

Leflunomide

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Mycophenolate Mofetil

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

Intervention Type: DRUG

Leflunomide

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

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

Management for IgG4-RD

Identifier Type: -

Identifier Source: org_study_id