Rheumatology Research Studies
Study Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
Study Purpose: The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).
Principal Investigator: Bashar Kahaleh, M.D.
Study Coordinator: Stephanie J. Smiddy, RN, for more information, please contact 419.383.6921.
Study Title: Prospective, Randomized, Placebo-controlled, Double-blind, Mutlicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Schemic Digital Ulcers Associated With Systemic Sclerosis.
Study Purpose: The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1.
Principal Investigator: Bashar Kahaleh, M.D.
Study Coordinator: Stephanie J. Smiddy, RN, for more information, please contact 419.383.6921.
Study Title: A Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Diffuse Cutaneous Systemic Sclerosis With Interstitial Lung Disease.
Study Purpose: The purpose of this first study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of pomalidomide (CC-4047) in the treatment of subjects with diffuse cutaneous systemic sclerosis with interstitial lung disease.
Principal Investigator: Bashar Kahaleh, M.D.
Study Coordinator: Stephanie J. Smiddy, RN, for more information, please contact 419.383.6921.
Study Title: A phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Tocilizumab versus Placebo in Patients with Systemic Sclerosis.
Study Purpose: This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with systemic sclerosis. Patients will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 49 to Week 96, all patients will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.
Principal Investigator: Bashar Kahaleh, M.D.
Study Coordinator: Stephanie J. Smiddy, RN, for more information, please contact 419.383.6921.
Study Title: Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative (QuERI) Extension Program.
Study Purpose: This program intends to improve the management of pulmonary arterial hypertension (PAH) patients through an evidence-based approach aimed at achieving optimal World Health Organization (WHO) functional class (FC): 1. Improving FC III & IV patients to FC II, 2. Improving FC II patients to FC I, and 3. Maintaining FC II & FC I patients.
Principal Investigator: Bashar Kahaleh, M.D.
Study Coordinator: Stephanie J. Smiddy, RN, for more information, please contact 419.383.6921.