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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:  A Double Blind, Randomised, Placebo-Controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at least 52 Weeks in Patients with 'Systemic Sclerosis associated Interstitial Lung Disease' (SSc-ILD)   (Identifier: NCT02597933)

Study Purpose:  Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

Principal Investigator: Bashar Kahaleh, M.D.

Study Coordinator:  Jennifer Gilmore, RN, 419.383.6761

Last Updated: 3/22/18