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Baricitinib in Relapsing Giant Cell Arteritis (GCA): A Phase II, Single-institution, Open-label Pilot Study (NCT03026504)

Eli Lilly and Company
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.
  • Drug: Baricitinib
    4 milligrams oral Baricitinib daily for 52 weeks
    • JAK2 Inhibitor
Ages eligible for Study
50 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.

1 locations

United States (1)
  • Mayo Clinic
    Rochester, Minnesota, United States, 55905
08 March, 2017
06 September, 2017
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