Short-term Glucocorticoid Combined with MMF for IgG4-RD

Not Applicable

Recruiting

• Conditions: IgG4-related Disease
• Interventions: Drug: prednison; Drug: Mycophenolate mofetil

• Registration Number: NCT06663618
• Lead Sponsor: Wen Zhang

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-09
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-26
• Last Update Submitted: 2024-10-26
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-03-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 63

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short-term glucocorticoid monotherapy	prednison	Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months.
short-term glucocorticoid combined with Mycophenolate mofetil	prednison	Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. Oral Mycophenolate mofetil 0.75g bid for 6 months.
short-term glucocorticoid combined with Mycophenolate mofetil	Mycophenolate mofetil	Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. Oral Mycophenolate mofetil 0.75g bid for 6 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 percentages of adverse events	72 weeks	Adverse effect of drugs
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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China