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Rheumatology Research

Study Title:  A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults with Active, Autoantiboy-Positsive Systemic Lupus Erythematous Treated with or without Benlysta™ (SABLE).  (Identifier: NCT01729455)

Study Purpose:  The purpose of this registry is to collect additional information regarding the side effects and effectiveness of BENLYSTA™ (belimumab) when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). Information will be collected on serious events that are not that common or may only be seen with long-term treatment. These events include death, cancers, serious infections and other infections of interest, and serious mental health problems. Information on the effectiveness of BENLYSTA™ will also be collected.

Principal Investigator: Nezam Altorok, M.D.

Study Coordinator:  Jennifer Gilmore, RN, 419.383.6761

Study Title:  Potential Benefit of non-invasive Vagus Nerve Stimulation (nVNS) using gammaCore in the treatment of Raynaud's Phenomena   (Identifier: NCT03869008)

Study Purpose:  Raynaud's phenomenon (RP) is a common vascular disorder that affects approximately 10% of  the general population.  RP is associated with significant morbidity that may include loss of the digits due to repeated episodes of vasospasm of the digital arteries in addition to significant impairment of quality of life.  It is well known that cold exposure precipitates episodes of RP, but the mechanism for cold sensitivity is not known, and treatment of RP is not satisfactory to the patients and their physicians.  The goal in this study is to test the possibility that non invasive vagus nerve stimulation (nVNS) with gammaCore, which is already approved by the FDA for headaches and migraines, may be an effective and well tolerated therapy for Raynaud's Phenomenon.

Principal Investigator: Bashar Kahaleh, M.D.

Study Coordinator:  Jennifer Gilmore, RN, 419.383.6761

Study Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis   (Identifier: NCT03398837)

Study Purpose:  To evaluate the efficacy of lenabasum compared to placebo in the treatment of diffuse cutaneous systemic sclerosis (SSc) by assessing change from baseline in the modified Rodnan skin score (mRSS) at Week 52.

Principal Investigator: Bashar Kahaleh, M.D.

Study Coordinator:  Jennifer Gilmore, RN, 419.383.6761

Last Updated: 4/23/19