Short-term Glucocorticoid Combined with MMF for IgG4-RD

Wen Zhang

Status: Enrolling

Conditions: IgG4-related Disease

Treatments: Drug: Mycophenolate mofetil; Drug: prednison

Study type: Interventional

Funder types: Other

Identifiers

NCT06663618

MMF for IgG4-RD

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-80 years old;
2. 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;
3. Active IgG4-RD (at least one organ has an IgG4-RD reaction score >=2 at the time of enrollment.)；
4. No previous medication or recurrence after withdrawal.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups, including a placebo group

short-term glucocorticoid monotherapy

Placebo Comparator group

Description:

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

Treatment:

Drug: prednison

short-term glucocorticoid combined with Mycophenolate mofetil

Experimental group

Description:

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.

Treatment:

Drug: prednison

Drug: Mycophenolate mofetil