Trial Details

Study goals:
Primary Sjögren’s syndrome is a disease in which a person’s own immune cells attack their tear and salivary glands causing dry mouth and dry eyes. Joint pain and fatigue are also common symptoms. Primary Sjögren’s syndrome is the second most common autoimmune disorder and affects close to four million people in the United States. The exact cause of the disease is still unknown; and currently no treatment is capable of modifying the disease. In this research study, baminercept is being used as an investigational therapy for primary Sjögren’s syndrome. We will evaluate baminercept’s effectiveness and safety for treating the symptoms and signs of Sjögren’s syndrome. The study will also provide information about baminercept’s affect on the underlying immune mechanisms of primary Sjögren’s syndrome. A description of this research study is available on http://www.ClinicalTrials.gov (NCT01552681).

Eligibility:
We are seeking participants who are between 18 and 75 years of age and have a diagnosis of primary Sjögren’s syndrome, and are bothered by dry eyes, dry mouth, joint pain and fatigue. Eligibility for study enrollment will be determined at a screening visit. You will not be able to participate in this study if you have a history of chronic or persistent infection including a past history of tuberculosis.

Study visits:
The study is divided into 3 phases that will take place over the course of about one year: a screening phase, treatment phase, and a follow up phase. All study visits are outpatient and take place at DUMC. The treatment phase consists of once weekly subcutaneous injections of study drug over the course of 6 months. The procedures for the study will be done at no cost to you and will include: brief physical exams, questionnaires about your health, blood and urine samples, chest x-ray, pulmonary function test, saliva flow rate tests, and eye exams by Duke Ophthalmologists.

Compensation:
You will receive reimbursement for your participation in the study to offset lost wages and for travel time. You will receive a total reimbursement of $650 for completing the entire study. A parking voucher will be provided for every study visit.

Contact:
For more information about the study please contact:
Gary McDaniel PA-C at (919)681-5871 or gary.mcdaniel@duke.edu
or
Edna Scarlett CRC at (919)684-6150 or edna.scarlett@dm.duke.edu

For more information, contact Gary McDaniel PA-C at (919) 681-5871.