Short-term Glucocorticoid Combined with MMF for IgG4-RD

NCT06663618 | Recruiting DMC

• 1 other identifier: MMF for IgG4-RD
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IgG4-related Disease

Keywords

IgG4-related disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The time of recurrence

  0-72 weeks

• The changes of IgG4-related disease Responder Index

  72 weeks

• The changes of serum IgG4 levels

  72 weeks

• The percentages of adverse events

  72 weeks

• The changes of PGA

  72 weeks

Study Arms (2)

short-term glucocorticoid monotherapy

PLACEBO COMPARATOR

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

Drug: prednison

short-term glucocorticoid combined with Mycophenolate mofetil

EXPERIMENTAL

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; Drug: Mycophenolate mofetil

Interventions

prednison DRUG

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

short-term glucocorticoid combined with Mycophenolate mofetil; short-term glucocorticoid monotherapy

Mycophenolate mofetil DRUG

Oral Mycophenolate mofetil 0.75g bid for 6 months.

short-term glucocorticoid combined with Mycophenolate mofetil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• 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;
• Active IgG4-RD (at least one organ has an IgG4-RD reaction score \>=2 at the time of enrollment.)；
• No previous medication or recurrence after withdrawal.

You may not qualify if:

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

Sponsors & Collaborators

• Wen Zhang: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

Prednisone; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Wen Zhang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linyi Peng, MD

CONTACT

8615810395901; drpenglinyi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 29, 2024
• Study Start: September 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-09

Locations

CN (1)