Clinical Trial: Glucocorticoids in Patients With IgG4-RD

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: This is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes.

Detailed Summary:
Sponsor: Peking Union Medical College Hospital

Current Primary Outcome: Complete Response [ Time Frame: 3 months ]

Complete Response(CR) is 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 [ Time Frame: 3 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.
  • Adverse Effect [ Time Frame: 3 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: December 24, 2012
Date Started: December 2012
Date Completion: April 2014
Last Updated: December 24, 2012
Last Verified: December 2012