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NCT Number: NCT06663618

Short-term Glucocorticoid Combined with MMF for IgG4-RD

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

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Key information

Conditions

IgG4-related Disease Autoimmune Diseases Immune System Diseases Immunoglobulin G4-Related Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Linyi Peng, MD

CONTACT

[email protected]

8615810395901

Wen Zhang, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

prednison

Drug

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

Mycophenolate mofetil

Drug

Oral Mycophenolate mofetil 0.75g bid for 6 months.

Primary outcomes

  1. The difference of recurrent rate of IgG4-RD between the two groups

    Time frame: 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 outcomes

  1. The time of recurrence

    Time frame: 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.

  2. The changes of IgG4-related disease Responder Index

    Time frame: 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.

  3. The changes of serum IgG4 levels

    Time frame: 72 weeks

    Level of serum IgG4(mg/dL)

  4. The percentages of adverse events

    Time frame: 72 weeks

    Adverse effect of drugs

  5. The changes of PGA

    Time frame: 72 weeks

    Changes of patient global assessment from baseline, score (0-10, higher is worse)

  6. The difference of remission rate of IgG4-RD between the two groups

    Time frame: 72 weeks

    Including complete remission rate, partial remission rate and total response rate.

Study contacts

Contact information is provided by the study sponsor or research team.

Linyi Peng, MD

CONTACT

[email protected]

8615810395901

Sponsors and collaborators

Lead sponsor

Wen Zhang

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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