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 ]
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