Clinical Studies

Washington University clinical rheumatology faculty are actively engaged in research projects on the leading edge of diagnosis and treatment. The table below presents research projects that are active or in preparation as of January, 2016. Rheumatology fellows are welcome to participate to gain experience with clinical trial protocol structure and implementation.

Current Clinical Research in the Washington University Division of Rheumatology
Name	Funding Source/ Protocol ID	WU Investigators	Activity Status	Description
CASTLE	Kypha, Inc	Dr. Kim	Enrolling	Single-center pilot study evaluating the relationship between blood iC3b and SLEDAI2K Responder Index-50 disease activity measurements in SLE patients
ADDRESS-II	Merck Serono	Drs. Kim, Brasington, Sen	Enrolling	Phase IIb, multicenter, randomized, double-blind, placebo-controlled, multidose, 52-week study to evaluate efficacy and safety of atacicept in SLE
CALIBATE	ITN/NIH	Drs. Kim, Li, Miner, Sen	Enrolling	Phase II, multicenter, prospective, randomized, open-label, 200-week study to evaluate the safety and efficacy of rituximab + cyclophosphamide followed by belimumab in individuals with active SLE nephritis
SPIRIT	1IF-MC-RHBE	Drs. Parks, Gonzalez-Mayda	Enrolling	Multicenter, randomized, double-blind, placebo-controlled 24-week study followed by long-term evaluation of efficacy & safety of Ixekizumab (LY2439821) in biologic disease-modifying antirheumatic drug-experienced patients with active psoriatic arthritis
SABLE		Dr. Brasington	Enrolling	5-year prospective observational registry to assess adverse events and effectiveness in adults with active, autoantibody-positive SLE treated with or without BENLYSTA™ (belimumab)
SLEEPS	Pilot Study	Drs. Kim, Chu, Thekkemuriyil	Enrolling	A prospective study evaluating relationships among patient reported sleep patterns, electronically monitored sleep quality, SLE activity, and selected sleep modifying variables
	NIH / EMR_700461-023	Dr. Kim	Enrolling	Phase IIb, multi-center, randomized, double-blind, placebo-controlled, multidose, 24-week study to evaluate efficacy & safety of atacicept in SLE patients
	HGS1006-C1112	Dr. Parks	Enrolling	Phase 3/4, multi-center, randomized, double-blind, placebo-controlled, 52-week study to evaluate efficacy & safety of Belimumab (HGS1006) in adult African Americans with SLE
	Pilot Study	Dr. Brasington	In Preparation	Prospective open label study of acthar subcu gel injection in patients with active anterior uveitis not controlled with or intolerant of topical or systemic corticosteroids
	ChemoCentryx	Dr. Parks	In Preparation	Randomized, double-blind, placebo-controlled, dose assessment Phase 2 study to evaluate safety & efficacy of CCX168 in patients with ANCA-associated vasculitis.
CALIBRATE		Dr. Kim	In Preparation	Rituximab + Cyclophosphamide followed by belimumab to treat SLE nephritis
SPIRIT P2	L1F-MC-RHBE	?	In Preparation	An investigation of safety and efficacy of Ixekizumab in biologic experienced patients with psoriatic arthritis.
REASON	NIH	Dr. Parks	In Preparation	Multi-institutional NIH study in which minimally invasive ultrasound guided synovial biopsies are performed on RA patients with active disease. Tissues and blood will be examined to identify potential biomarkers for therapeutic response.