Clinical Trial: Ustekinumab for the Treatment of Giant Cell Arteritis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Open Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell Arteritis
Brief Summary: The purpose of this study is to determine whether ustekinumab is effective in the treatment of Giant Cell Arteritis (GCA)
Detailed Summary:
The objective of this study is to evaluate the efficacy and safety of ustekinumab, an interleukin (IL)-12/23 inhibitor, in patients with GCA
Hypothesis IL-12/23 pathway blockade may maintain disease remission in patients with GCA
Specific Aims
- To evaluate the safety and tolerability of ustekinumab administration in 20 patients with GCA
- To evaluate the efficacy of ustekinumab for remission maintenance and glucocorticoid sparing in 20 patients with GCA
Sponsor: Massachusetts General Hospital
Current Primary Outcome: Percentage of patients in glucocorticoid-free remission [ Time Frame: 52 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of disease flares [ Time Frame: 52 weeks ]
- Cumulative prednisone dose [ Time Frame: 52 weeks ]
Original Secondary Outcome: Same as current
Information By: Massachusetts General Hospital
Dates:
Date Received: October 31, 2016
Date Started: December 1, 2016
Date Completion: March 2020
Last Updated: February 16, 2017
Last Verified: September 2016
