NCT02955147

Ustekinumab for the Treatment of Giant Cell Arteritis

Open Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell Arteritis

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether ustekinumab is effective in the treatment of Giant Cell Arteritis (GCA)

Detailed description

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

Conditions

• Giant Cell Arteritis
• Temporal Arteritis
• Horton's Disease

Interventions

Type	Name	Description
DRUG	Ustekinumab	Ustekinumab is a humanized monoclonal antibody that targets the p40 subunit of IL-12 and IL-23 and inhibits cytokine - cytokine receptor coupling and signaling
DRUG	Prednisone	Prednisone is an anti-inflammatory medication

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-07-25
• Completion: 2019-09-19
• First posted: 2016-11-04
• Last updated: 2020-06-12
• Results posted: 2020-06-12

Locations

1 site across 1 country: United States