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Recruiting NCT06663618

Short-term Glucocorticoid Combined with MMF for IgG4-RD

No phase Interventional IgG4-related Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: prednison, Mycophenolate mofetil.
Who it may be relevant to
Registry conditions: IgG4-related Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • The difference of recurrent rate of IgG4-RD between the two groups [Time frame: 72 weeks]
Secondary outcome measures (6)
  • The time of recurrence [Time frame: 0-72 weeks]
  • The changes of IgG4-related disease Responder Index [Time frame: 72 weeks]
  • The changes of serum IgG4 levels [Time frame: 72 weeks]
  • The percentages of adverse events [Time frame: 72 weeks]
  • The changes of PGA [Time frame: 72 weeks]
  • The difference of remission rate of IgG4-RD between the two groups [Time frame: 72 weeks]

Eligibility criteria

Inclusion criteria

  • 18-80 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06663618 · MMF for IgG4-RD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗