PulSar Study - Pulmonary Sarcoidosis

STUDY BASICS

Diagnosed with pulmonary sarcoidosis and currently taking prednisone medication? If so, you may be able to participate in a research study to help find out if adding a medication called Acthar® to your current treatment regimen is safe and effective for people with pulmonary sarcoidosis. Reimbursement for reasonable expenses associated with your participation in the study will be provided.

STUDY PURPOSE

Pulmonary sarcoidosis is a rare disease in which tiny clusters of inflammatory cells called granulomas form in the lungs. Although many people with the disease do not have any symptoms, others may experience shortness of breath, cough, chest pain, and fatigue. Oral steroid medications such as prednisone are the most common treatment for people with symptomatic pulmonary sarcoidosis, but these medications do not always provide complete symptom relief. The purpose of this study is to help researchers find out if adding a medication called Acthar® to a patient’s existing treatment regimen is safe and effective for people with pulmonary sarcoidosis. Acthar® is an FDA-approved drug that is believed to work by helping the body produce its own natural steroid hormones. Researchers hope their findings will lead to better treatments for sarcoidosis in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18-90
• Diagnosed pulmonary sarcoidosis
• Currently taking prednisone for your pulmonary sarcoidosis, but are still experiencing symptoms

WHAT PARTICIPANTS CAN EXPECT

Participation includes a 4 week screening period that includes a physical exam, collection of blood and urine samples, electrocardiogram, chest X-ray, CT scan, TB test, breathing tests, questionnaires, and collection of an optional genetic sample. Some tests and assessments will be repeated throughout the course of the study. If eligible after screening, participation involves up to 12 visits over 14 months. During the first visit after screening, participants will be randomly assigned (like the flip of a coin) to receive either Acthar® or a placebo for about 6 months. A placebo is an inactive substance that looks the same as Acthar® and is given the same way as Acthar, but contains no active ingredient. Acthar® or placebo is administered as an injection under the skin twice weekly by you or your caregiver. During visit 8, participants in the placebo group can choose to receive Acthar® and participants who were already receiving Acthar® can choose to continue it for another 6 months. Participants will have a final follow-up visit at about 4 weeks after the last dose of the study drug. Reimbursement of $50 per visit for reasonable expenses associated with your participation in the study will be provided.