Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

NCT05789017 | Recruiting

• 1 other identifier: Management for IgG4-RD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study has been designed as a 18-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in active IgG4-RD patients with internal organ involvement during maintenance remission period: low dose mycophenolate mofetil group and leflunomide group.

Conditions

Autoimmune Diseases

Keywords

Immunoglobulin G4-Related Disease; treatment strategies; relapse; leflunomide; mycophenolate mofetil

Outcome Measures

Primary Outcomes (1)

• The difference of relapse rate of IgG4-RD between two groups in 18 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.

  18 months

Secondary Outcomes (3)

• The difference of the time at baseline to first relapse between two groups.

  18 months

• Response rate to the treatment of the two groups.

  18 months

• Side effects

  18 months

Study Arms (2)

Group I

EXPERIMENTAL

Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months. Afterwards, patients are treated with low dose mycophenolate (1-1.5g/day) during remission maintenance period for 12 months.

Drug: Prednisone and Mycophenolate Mofetil; Drug: Mycophenolate Mofetil

Group II

EXPERIMENTAL

Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months. Afterwards, patients are treated with leflunomide (20 mg/day) during remission maintenance period for 12 months.

Drug: Prednisone and Mycophenolate Mofetil; Drug: Leflunomide

Interventions

Prednisone and Mycophenolate Mofetil DRUG

Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months.

Group I; Group II

Mycophenolate Mofetil DRUG

Patients are treated with low dose mycophenolate (1-1.5g/day) during remission maintenance period for 12 months.

Group I

Leflunomide DRUG

Patients are treated with leflunomide (20 mg/day) during remission maintenance period for 12 months.

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.

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

Prednisone; Mycophenolic Acid; Leflunomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; 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: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CN (1)