Health TrialsbyHealthPanel

Short-term Glucocorticoid Combined with MMF for IgG4-RD

ConditionIgG4-related Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWen Zhang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Combined with other autoimmune diseases as the main diagnosis.

Pregnant or lactating women

Patients with malignant tumor

Active bacterial, fungal, viral or mycobacterial infections.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

63 Participants
are divided into 2 treatment groups
Group A: short-term glucocorticoid monotherapyPlacebo comparator 1 intervention
Group B: short-term glucocorticoid combined with Mycophenolate mofetilExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
72 weeks

Secondary outcomes

1

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.

Time frame
0-72 weeks
2

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.

Time frame
72 weeks
3

The changes of serum IgG4 levels

Level of serum IgG4(mg/dL)

Time frame
72 weeks
4

The percentages of adverse events

Adverse effect of drugs

Time frame
72 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wen Zhang

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now