Vivek Nagaraja, M.B.B.S., M.D.

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• A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD) (SSc-ILD) Scottsdale/Phoenix, Ariz.

  The purpose of this study is to assess the safety, tolerability, and effectiveness of PRA023 in subjects with Systemic Sclerosis (SSc) with diffuse cutaneous disease and Interstitial Lung Disease (ILD). 

• A Multicenter, Randomized, Parallel-group, Double-blind, Two-arm, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis (DAISY) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this multinational, randomized, placebo-controlled, and double­ blind study is to evaluate the safety and efficacy of subcutaneous (SC) anifrolumab in adult patients with systemic sclerosis (SSc), who may be taking one or a combination of protocol­ specified standard therapies. Following 52-weeks of double-blind, placebo-controlled treatment, a 52-week open-label treatment period is included to assess long-term safety in Systemic Sclerosis (SSc).

• A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD) (BLISSc-ILD) Scottsdale/Phoenix, Ariz.

  The purpose of this study is to determine the effectiveness and safety of belimumab compared to placebo in adults with systemic sclerosis (SSc) associated interstitial lung disease (ILD).

• Nintedanib Plus Standard of Care Immunosuppression Versus Standard of Care Immunosuppression Alone in Patients With Progressive Fibrotic Myositis Associated - Interstitial Lung Disease: A Randomized, Double-Blind, Exploratory Trial (MINT) Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD).

  Interstitial lung disease is a disorder caused by the abnormal accumulation of cells structures between air sacs of the lungs resulting in thickening, stiffness and scarring of the tissues of the lung. This study will enroll a total of 134 participants across 15 clinical sites located in the United States. A subset of participants will be enrolled remotely via telemedicine utilizing certified mobile home research nurses and various remote monitoring devices. The research visits may include a physical exam, vital signs (such as blood pressure, heart rate, etc.), pulmonary function tests (PFT and/or home spirometry), Computerized Tomography (or CT) scans of the chest, blood draws, wearing a physical activity monitor and completing questionnaires. Some of these events may be done at home, at a local facility or remotely (via telemedicine).