The purpose of this study is to compare an imaging procedure called high-resolution computed tomography (HRCT) against the standard pulmonary function tests (PFTs) to see if HRCT is better at showing if the standard glucocorticoid treatment is working. This study also includes testing of blood samples for biomarkers which are measurable indicators of the severity or presence of some disease state. The maximum time you will be in the study is 3 months. During this time, you will need to visit the study site 6 times for 6 site study visits. This study will enroll subjects with a diagnosis of pulmonary sarcoidosis at stage II or III who have shortness of breath (dyspnea) and have not received prednisone or prednisolone (glucocorticoids) treatment or other sarcoidosis therapy within the last three months.
The purpose of the study is to generate a bio bank of specimens for research. We will tissue that would otherwise be discarded from clinical or surgical procedure and information from medical records. We will also collect discarded blood, urines and sputum. Collecting samples will help to better understanding the mechanisms of cardiovascular diseases, identify biomarkers for early diagnosis and to predict safety and efficacy of new therapies.
The purpose of this research study is to find out if Acthar works well in and is safe when you use it as part of the treatment for your Pulmonary Sarcoidosis. This research study will collect additional data as to the effectiveness and safety of Acthar in treating Pulmonary Sarcoidosis, and will examine how the study drug acts in the body and how well it manages your symptoms. Participation could last for approximately 56 weeks. This will include a Screening Period that will last up to 4 weeks, a double-blind treatment period of about 6 months when neither you nor your study doctor will know if you are taking Acthar or placebo, an open-label treatment period of about 6 months, and a follow-up visit at about 4 weeks after the last dose of the study drug. The study plan includes coming to the study doctor's research center at least 12 times if you participate throughout the whole study duration of 56 weeks or 9 times if you participate only in the double-blind period.
Approximately 100 people will participate in this study.
You are being asked to take part in this research study because you have been diagnosed with pulmonary sarcoidosis. Sarcoidosis is a disease that can affect the lungs, skin and other organs of the body. Sarcoidosis also involves immune cells which fight bacteria. The purpose of this study is to see if using specific antibiotics will help these immune fighting cells get rid of bacterial proteins and how the antibiotics affect respiratory (breathing) function. The antibiotics used in this study are Levaquin, Ethambutol, Azithromycin, and either Rifampin or Rifabutin. You will by chance be assigned either these medicines or a placebo (an inactive substance).
The purpose of this study is to create and maintain a registry, which is a database (a searchable collection of information) about children, adolescents and young adults with pediatric onset of rheumatic diseases. This data may help in the evaluation of the safety and benefit of medications that are prescribed to patients who have rheumatic diseases.