Short-term Glucocorticoid Combined with MMF for IgG4-RD

Comparison of Short-term Glucocorticoid Monotherapy and Short-term Glucocorticoid Combined with Mycophenolate Mofetil in the Treatment of IgG4 Related Disease

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06663618

Enrollment

Registered

2024-10-29

Start date

2023-09-01

Completion date

2025-09-01

Last updated

2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgG4-related Disease

Keywords

IgG4-related disease

Brief summary

Comparison of short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease

Detailed description

This is a monocenter, 72-week prospective, randomized controlled study to compare short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease.

Interventions

DRUGprednison

Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months.

DRUGMycophenolate mofetil

Oral Mycophenolate mofetil 0.75g bid for 6 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. 18-80 years old; 2. All patients must meet the comprehensive diagnostic criteria of IgG4-RD revised in Japan in 2020 or the classification criteria of IgG4-RD formulated by ACR/EULAR in 2019; 3. Active IgG4-RD (at least one organ has an IgG4-RD reaction score \>=2 at the time of enrollment.)； 4. No previous medication or recurrence after withdrawal.

Exclusion criteria

1. Combined with other autoimmune diseases as the main diagnosis. 2. Pregnant or lactating women 3. Patients with malignant tumor 4. Active bacterial, fungal, viral or mycobacterial infections. 5. Severe complications of important organs, and the expected survival time is less than 6 months.

Design outcomes

Primary

Measure	Time frame	Description
The difference of recurrent rate of IgG4-RD between the two groups	72 weeks	Clinical recurrence definition: any item of IgG4-RD Responder Index \>=2 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels.

Secondary

Measure	Time frame	Description
The changes of IgG4-related disease Responder Index	72 weeks	According to international multispecialty validation study of IgG4-related disease Responder Index (November, 2018), Responder Index ≥ 0, and higher scores mean a worse outcome.
The changes of serum IgG4 levels	72 weeks	Level of serum IgG4(mg/dL)
The time of recurrence	0-72 weeks	Clinical recurrence definition: any item of IgG4-RD Responder Index \>=2 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels.
The changes of PGA	72 weeks	Changes of patient global assessment from baseline, score (0-10, higher is worse)
The difference of remission rate of IgG4-RD between the two groups	72 weeks	Including complete remission rate, partial remission rate and total response rate.
The percentages of adverse events	72 weeks	Adverse effect of drugs

Countries

China

Contacts

Primary ContactLinyi Peng, MD

drpenglinyi@163.com8615810395901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026