NCT05974683

Treatment Strategies in IgG4-RD Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period

A Study of Two Different Treatment Strategies in IgG4-related Disease Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period: a Randomized Double Blind Placebo Controlled Multicenter Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study has been designed as a 52-week, randomized double blind placebo controlled multicenter clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with re-elevation of serum IgG4 level during maintenance remission period: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD).

Detailed description

108 IgG4-RD patients with re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period are to be enrolled in this study after screening period, and then double blind randomly in an 1:1 ratio into two groups: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD plus placebo) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD). The follow-up period will be 52 weeks. During the follow-up period, clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded. The primary endpoint is the difference of relapse rate between two groups at 52 weeks. Meanwhile, this study will also explore and study different biomarkers in IgG4-RD patients, to better understand the mechanisms, as well as prognostic factors of IgG4-RD.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	placebo	Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
DRUG	mycophenolate mofetil	Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-08-03
• Last updated: 2023-08-03

Locations

1 site across 1 country: China