Clinical Trial: Baricitinib in Relapsing Giant Cell Arteritis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Baricitinib in Relapsing Giant Cell Arteritis (GCA): A Phase II, Single-institution, Open-label Pilot Study
Brief Summary: This study will evaluate the safety and effectiveness of baricitinib in the treatment of giant cell arteritis. All participants will be taking prednisone at the start of the study. The prednisone will be reduced according to a standardized tapering schedule while participants continue to take one tablet of baricitinib daily for 52 weeks.
Detailed Summary:
Baricitinib, an orally administered, potent, selective and reversible inhibitor of JAK1 and JAK2 has shown preliminary safety and efficacy in chronic, immune-mediated inflammatory conditions such as rheumatoid arthritis and psoriasis. This small molecule is uniquely suited as a potential novel therapeutic agent in GCA because of its suppressive effect on both the Th17 (IL-6, IL-23) andTh1 (IL-12, IFN-γ) pathways.
This study will evaluate the safety and tolerability of baricitinib in a population of patients with relapsing GCA. The study is an open-label pilot study assessing the safety and tolerability of baricitinib (4 mg daily, oral, for 52 weeks) in addition to a standardized glucocorticoid taper. It is anticipated that adjunct baricitinib will be safe and well tolerated by patients with GCA and demonstrate preliminary efficacy as measured by reducing inflammatory markers, decreasing steroid requirements and increasing relapse-free survival.
Sponsor: Matthew J Koster
Current Primary Outcome: Percentage of subjects experiencing adverse events [ Time Frame: 52 weeks ]
Original Primary Outcome: Percentage of subjects experiencing adverse events [ Time Frame: 52 weeks ]
Current Secondary Outcome:
- Giant Cell Arteritis relapse-free survival [ Time Frame: 24 weeks ]Proportion of patients in sustained remission of disease
- Giant Cell Arteritis relapse-free survival [ Time Frame: Week 52 ]Proportion of patients in sustained remission of disease
- Giant Cell Arteritis relapse-free survival [ Time Frame: Weeks 0 to 52 ]Duration of glucocorticoid-free remission
- Giant Cell Arteritis relapse-free survival [ Time Frame: Weeks 0-52 ]Number of first relapse
Original Secondary Outcome: Giant Cell Arteritis relapse-free survival [ Time Frame: 52 weeks ]
Information By: Mayo Clinic
Dates:
Date Received: January 17, 2017
Date Started: March 9, 2017
Date Completion: June 2021
Last Updated: April 13, 2017
Last Verified: April 2017