Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

Autoimmune Diseases Clinical Trial

Official title:

Efficacy of Mycophenolate Mofetil Versus Leflunomide as Maintenance Treatment for IgG4-RD Patients With Internal Organ Involvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05789017
• Other study ID #: Management for IgG4-RD
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Peking Union Medical College Hospital
• Contact: Yunyun Fei, MD
• Phone: 01069159953
• Email: feiyunyun[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

60 active IgG4-RD patients with internal organ involvement are enrolled in this study and accept the combination treatment of glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months. During remission maintenance period, pateints are randomly divided into two groups at a 1:1 ratio: patients in group I are treated with low dose mycophenolate mofetil (1-1.5g/day) and patients in group Ⅱ accept the treatment of leflunomide (20 mg/day). Patients in two groups will be followed up for another 12 months, and clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded during follow up. The primary endpoint is the difference of relapse rate between two groups at 18 months. The secondary endpoints are relapse time, response rate and side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1. 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.

Exclusion Criteria:

• 1. 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.

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

Drug:
• Prednisone and Mycophenolate Mofetil
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.
• Mycophenolate Mofetil
Patients are treated with low dose mycophenolate (1-1.5g/day) during remission maintenance period for 12 months.
• Leflunomide
Patients are treated with leflunomide (20 mg/day) during remission maintenance period for 12 months.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The difference of the time at baseline to first relapse between two groups.		18 months
Secondary	Response rate to the treatment of the two groups.	Complete response rate; Partial response rate; No response	18 months
Secondary	Side effects	Any side effects caused by treatments for IgG4-RD.	18 months