Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05789017

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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 two treatment strategies in active IgG4-RD patients with internal organ involvement during maintenance remission period: low dose mycophenolate mofetil group and leflunomide group.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Diseases	Drug: Prednisone and Mycophenolate Mofetil Drug: Mycophenolate Mofetil Drug: Leflunomide	N/A

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 3 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 (0.5-1g/day) and patients in group Ⅱ accept the treatment of leflunomide (10-20 mg/day). Patients in two groups will be followed up for another 6 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Mycophenolate Mofetil Versus Leflunomide as Maintenance Treatment for IgG4-RD Patients With Internal Organ Involvement

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 4 months. Afterwards, patients are treated with low dose mycophenolate (0.5-1g/day) during remission maintenance period for 9 months.	Drug: 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 4 months. Drug: Mycophenolate Mofetil Patients are treated with low dose mycophenolate (0.5-1g/day) during remission maintenance period for 9 months.
Experimental: 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 4 months. Afterwards, patients are treated with leflunomide (10-20 mg/day) during remission maintenance period for 9 months.	Drug: 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 4 months. Drug: Leflunomide Patients are treated with leflunomide (10-20 mg/day) during remission maintenance period for 9 months.

Arm

Intervention/Treatment

Experimental: 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 4 months. Afterwards, patients are treated with low dose mycophenolate (0.5-1g/day) during remission maintenance period for 9 months.

Drug: 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 4 months.

Drug: Mycophenolate Mofetil

Patients are treated with low dose mycophenolate (0.5-1g/day) during remission maintenance period for 9 months.

Experimental: 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 4 months. Afterwards, patients are treated with leflunomide (10-20 mg/day) during remission maintenance period for 9 months.

Drug: 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 4 months.

Drug: Leflunomide

Patients are treated with leflunomide (10-20 mg/day) during remission maintenance period for 9 months.

Outcome Measures

Primary Outcome Measures

The difference of relapse rate of IgG4-RD between two groups in 12 months. [15 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

The difference of the time at baseline to first relapse between two groups. [12 months]
Response rate to the treatment of the two groups. [12 months]
Complete response rate; Partial response rate; No response
Side effects [15 months]
Any side effects caused by treatments for IgG4-RD.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.