NCT02458196

Study of Treatment Response on IgG4 Related Disease (IgG4RD)

A Randomized Trial of Treatment in Patients With IgG4-Related Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label randomized controlled trial to compare the efficacy of Prednisone alone and combination therapy of Prednisone and Mycophenolate mofetil in IgG4RD patients.

Detailed description

Patients with IgG4-RD will be randomized in two therapeutic groups: Prednisone alone and combination therapy with Prednisone and Mycophenolate mofetil. These patients will be followed in 12 months. Treatment response and relapse will be recorded, as well as side effects.

Conditions

• Autoimmune Disease

Interventions

Type	Name	Description
DRUG	Prednisone	Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 10mg/d to 12 months.
DRUG	Prednisone and Mycophenolate mofetil	Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months. Immunosuppressive drugs: Mycophenolate mofetil 1g/d-1.5g/d for 6 months and 0.5/d-1.0g/d for 6 months.

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-06-01
• Completion: 2018-06-01
• First posted: 2015-06-01
• Last updated: 2017-01-24

Locations

1 site across 1 country: China