Kenneth J. Warrington, M.D.

Closed for Enrollment

• A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis Rochester, Minn.

  The primary purpose of this study is to evaluate the effectiveness and safety of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).

• A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects with Giant Cell Arteritis Rochester, Minn.

  The purpose of this study is to evaluate the effectiveness and safety of RoActemra/Actemra (tocilizumab) for the treatment of patients who have giant cell arteritis.

• A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART) (ABAGART) Rochester, Minn.

  The purpose of this study is to determine the effectiveness of abatacept in Giant Cell Arteritis (GCA).  Patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized to receive subcutaneous abatacept or placebo.  All patients will receive glucocorticoids (GC) which will be tapered and discontinued by week 26 according to a standardized schedule. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months, or who are in remission, complete the randomized treatment period, and then experience relapse within the first 6 months following study drug discontinuation will have the option of receiving open-label abatacept for a maximum of 12 months.

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

  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.

• VCRC Imaging Protocol for Magnetic Resonance and Positron Emission Tomography in Large-vessel Vasculitis (Takayasu's Arteritis):Development as Clinical Trial Outcome Measures Rochester, Minn.

  Assessing disease activity in people with Takayasu's arteritis is difficult, as most people with the disease do not exhibit visible, measurable symptoms. Combination positron emission tomography/computed axial tomography (PET/CT) is a particularly sensitive, accurate scanning method that may improve researchers' ability to evaluate people with the disease. This study will determine the effectiveness of PET/CT in assessing disease activity in people with Takayasu's arteritis.