Short-term Glucocorticoid Combined with MMF for IgG4-RD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-09-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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IgG4-related Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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short-term glucocorticoid monotherapy

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

Group Type PLACEBO_COMPARATOR

prednison

Intervention Type DRUG

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

short-term glucocorticoid combined with Mycophenolate mofetil

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.

Group Type EXPERIMENTAL

prednison

Intervention Type DRUG

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

Mycophenolate mofetil

Intervention Type DRUG

Oral Mycophenolate mofetil 0.75g bid for 6 months.

Interventions

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prednison

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

Intervention Type DRUG

Mycophenolate mofetil

Oral Mycophenolate mofetil 0.75g bid for 6 months.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No