RecruitingNot ApplicableNCT06663618

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


Sponsor

Wen Zhang

Enrollment

63 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

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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.


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06663618


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