Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

NCT05789030 | Recruiting

• 1 other identifier: IgG4-RD, superficial organ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study has been designed as a 12-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with superficial organ involvement: prednisone plus iguratimod and prednisone plus leflunomide.

Conditions

Autoimmune Diseases

Keywords

Immunoglobulin G4-Related Disease; treatment strategies; iguratimod; leflunomide; relapse

Outcome Measures

Primary Outcomes (1)

• The difference of relapse rate of IgG4-RD among 2 groups in 12 months.

  The definition of relapse: elevation of IgG4-RD Responder Index ≥ 2 points; new organ involvement or recurrence, with or without elevation of serum IgG4 levels.

  12 months

Secondary Outcomes (3)

• The difference of the time at baseline to first relapse among 2 groups

  12 months

• The difference of the response rate of the treatment among the 2 groups.

  12 months

• Side effects

  12 months

Study Arms (2)

Group I

EXPERIMENTAL

Patients are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months) and iguratimod (25 mg bid).

Drug: glucocorticoid plus iguratimod

Group II

EXPERIMENTAL

Patients are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months ) and leflunomide (10-20 mg qd).

Drug: glucocorticoid plus leflunomide

Interventions

glucocorticoid plus iguratimod DRUG

Patients in Group I are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months) and iguratimod (25 mg bid).

Group I

glucocorticoid plus leflunomide DRUG

Patients in Group II are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≦ 5mg in 3 months ) and leflunomide (10-20 mg qd).

Group II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria; 2. Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment; 3. The addition of glucocorticoids was started at lower than 10 mg/d.

You may not qualify if:

• \. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women； 4. Active infection: HIV, HCV, HBV, TB； 5. Severe irreversible damage of organ function; 6. Receipt of any biologic therapy or immunosuppressive agent other than GCs.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases; Immunoglobulin G4-Related Disease; Recurrence

Interventions

Glucocorticoids; iguratimod; Leflunomide

Condition Hierarchy (Ancestors)

Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wen Zhang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunyun Fei, MD

CONTACT

01069159953; feiyunyun@pumch.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: July 1, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-04

Locations

CN (1)