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

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

Study Overview

• Status: Recruiting
• Conditions: IgG4-related Disease
• Intervention / Treatment: Drug: prednison; Drug: Mycophenolate mofetil

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.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linyi Peng, MD; Phone Number: 8615810395901; Email: drpenglinyi@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Linyi Peng, MD; Phone Number: 8615810395901; Email: drpenglinyi@163.com
      • Contact: Wen Zhang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: short-term glucocorticoid monotherapy; Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months.	Drug: prednison; Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months.
Experimental: short-term glucocorticoid combined with 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.	Drug: prednison; Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months.; Drug: Mycophenolate mofetil; Oral Mycophenolate mofetil 0.75g bid for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of recurrent rate of IgG4-RD between the two groups	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.	72 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time of recurrence	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.	0-72 weeks
The changes of IgG4-related disease Responder Index	According to international multispecialty validation study of IgG4-related disease Responder Index (November, 2018), Responder Index ≥ 0, and higher scores mean a worse outcome.	72 weeks
The changes of serum IgG4 levels	Level of serum IgG4(mg/dL)	72 weeks
The percentages of adverse events	Adverse effect of drugs	72 weeks
The changes of PGA	Changes of patient global assessment from baseline, score (0-10, higher is worse)	72 weeks
The difference of remission rate of IgG4-RD between the two groups	Including complete remission rate, partial remission rate and total response rate.	72 weeks

Collaborators and Investigators

• Sponsor: Wen Zhang
• Investigators: Principal Investigator: Wen Zhang, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 26, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: IgG4-related disease
• Additional Relevant MeSH Terms: Autoimmune Diseases; Immune System Diseases; Immunoglobulin G4-Related Disease; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antibiotics, Antitubercular; Antitubercular Agents; Mycophenolic Acid
• Other Study ID Numbers: MMF for IgG4-RD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No