Clinical Trial: Study of Treatment Response on IgG4 Related Disease (IgG4RD)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Peking Union Medical College Hospital

Current Primary Outcome: Complete and partial response rate at 3, 6, 9 and 12 months. [ Time Frame: Up to 12 months ]

Complete and partial response are defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease response at 3, 6, 9 and 12 months. [ Time Frame: Up to 12 months ]

    Disease response is measured by IgG4-RD Responder Index(IgG4-RD RI) and defined as:

    • Improvement of >2 points in the IgG4-RD RI over baseline
    • No disease flares, as assessed by the IgG4-RD RI.
  • Number of participants with adverse effect [ Time Frame: Up to 12 months ]
    Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.


Original Secondary Outcome: Same as current

Information By: Peking Union Medical College Hospital

Dates:
Date Received: April 15, 2015
Date Started: April 2015
Date Completion: June 2018
Last Updated: January 23, 2017
Last Verified: December 2016