Clinical Trials
- A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple VAY736 doses administered subcutaneously in patients with moderate to severe primary Sjögren’s Syndrome (Enrollment Complete)
- A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) (Enrollment Starting Spring 2020)
Other Research Studies
Longitudinal Study of a Prospective Cohort of Patients with Sjögren’s Syndrome
Dr. Alan Baer has established a Sjögren’s syndrome cohort in the Jerome L. Greene Sjögren’s Syndrome Center. Information is being collected about the clinical history and long-term disease progression of patients with suspected or established Sjögren’s syndrome. Questionnaires, sera and salivary glands are collected upon entry into the study. Questionnaires are distributed electronically every 3 months and sera is collected bi-annually and stored for future studies. This cohort consists of over one thousand participants and continues to grow.
Sjögren’s Syndrome Screening Dry Eye Study (SSDE Study)
- PI: Dr. Alan Baer
- Co-Investigator: Dr. Esen Akpek
Sjögren’s syndrome is a systemic autoimmune disorder characterized by lymphocytic infiltration of the salivary and lacrimal glands and other organs along with systemic production of autoantibodies. The involvement of salivary and lacrimal glands leads to progressive decreases in the quantity and quality of saliva and tears and impaired quality of life. Local treatment of the dry eyes and mouth can prevent complications, but does not appear to alter the course of the disease. Early diagnosis and implementation are critical in improving patients’ quality of life and treating complications.
Patients often first present to ophthalmologist with complaints of dry eye, and as a result ophthalmologists are in a unique position to screen patients for possible Sjögren’s syndrome. However, currently there are no evidence-based screening tools for ophthalmologists to use to identify patients with a high likelihood of having Sjögren’s syndrome. The central hypothesis of this research is that using a screening algorithm comprised of a combination of questionnaire responses, autoantibody tests and standard dry eye exam findings will stratify dry eye patients into those having high, medium or low likelihood of having Sjögren’s syndrome.
Neuropathy and Sjögren’s Syndrome
Dr. Julius Birnbaum’s research bridges distressing symptoms which may affect Sjögren’s syndrome patients with neurological complaints, by capitalizing on the collaborative energy and passion of world-class basic scientists unified to help identify mechanisms and potential treatments.
Many Sjögren’s syndrome patients with devastating neuropathies have delayed diagnoses, because the blood work does not show any evidence of abnormal antibodies. Our preliminary work shows that nearly 50 percent of Sjögren’s patients with neuropathies lack these antibodies. Using the expertise of the Rheumatology Core Laboratory, we are seeking to identify novel and previously unidentified antibodies, which will provide insight into relevant mechanisms, and suggest therapeutic opportunities.
Sjögren’s syndrome patients may have brain lesions which can be misattributed to Multiple Sclerosis (MS). Ongoing studies with the Neuroimmunology Division is focusing on studying messengers called “cytokines”, which are seen in Sjögren’s syndrome patients, but not individuals with MS.
To alleviate the symptoms, pain, and sense of disenfranchisement which accompanies Sjögren’s patients with neurologic disease, Dr. Birnbaum is formalizing a cross-disciplinary program with psychiatrists, physiatrists, anesthesiologists, and neurosurgeons at the world-renown Blau Pain Management Center.
