Sjögren's syndrome is an autoimmune disorder in which a person's own immune cells attack the body's tear and salivary glands. This disease is the second most common autoimmune disorder, affects close to four million people in the U.S., and has no known cause. About one-third of patients with Sjögren's syndrome have enlarged parotid glands (the largest salivary glands, the glands that make saliva); inflammation of organs such as the lungs and joints may also occur. There is no known effective treatment other than measures that can relieve symptoms. One of the most bothersome symptoms is dryness of the eyes and mouth. Eye drops and saliva stimulants (which help make more saliva) are common treatments. When other organs are affected, symptoms are treated with corticosteroids (prednisone), non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen and naproxen), hydroxychloroquine (Plaquenil®) or other medications that suppress the immune system. These drugs may curb or kill cells of the immune system, but they are not always helpful, do not cure Sjögren's syndrome, and can have many side effects.
The purpose of the study is to find out if the experimental study agent, baminercept, is effective in treating patients with Sjögren's syndrome. The study will also determine if the study agent can be safely given to patients with Sjögren's syndrome; examine how it affects symptoms of the disease; and attempt to understand how baminercept affects the underlying mechanisms of Sjögren's syndrome and the immune system.
| United States, California | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
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Contact: Erin Avila 310-423-2979 eavila@wallacemedical.com |
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| Principal Investigator: Daniel Wallace, MD | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
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Contact: Mark Genovese, MD 650-498-4528 genovese@stanford.edu |
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| Contact: Jennifer Hillygus-Kanerva (650) 723-7416 jhillygu@stanford.edu | |
| Principal Investigator: Mark Genovese, MD | |
| United States, Connecticut | |
| St. Francis Hospital and Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06105 | |
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Contact: Betsy Keller, RN 860-714-4555 bkeller@stfranciscare.org |
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| Contact: Ann Parke, MD (860) 714-5816 aparke@stfranciscare.org | |
| Principal Investigator: Ann Parke, MD | |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
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Contact: Elizabeth Yan 773-834-5357 eyan@medicine.bsd.uchicago.edu |
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| Principal Investigator: Tammy Utset, MD | |
| United States, Maryland | |
| Johns Hopkins Medical Institute | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Rebecca Ozl, CRC 410-550-6492 rozl1@jhmi.edu | |
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Principal Investigator: Alan Baer, MD |
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| United States, New York | |
| University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
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Contact: Debbie Campbell, RN 585-275-1635 debbie_campbell@urmc.rochester.edu
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| Principal Investigator: Andreea Coca, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
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Contact: Edna Scarlett 919-684-6150 scarl001@mc.duke.edu
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Contact: Gary McDaniel, PA-C (919) 681-5871 gary.mcdaniel@duke.edu
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| Principal Investigator: E. William St. Clair, MD | |
| United States, Oklahoma | |
| Oklahoma Medical Research Foundation | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
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Contact: Virginia Roberts, LPN 405-271-7221 robertsv@omrf.org
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| Principal Investigator: Judith James, MD, PhD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15260 | |
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Contact: Kimberly Diamond 412-586-3546 diamondkl@upmc.edu
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| Principal Investigator: Robin C. Domsic, MD |
| Study Chair: | E. William St. Clair, MD | Duke University | |
| Study Chair: | Judith A. James, MD | Oklahoma Medical Research Foundation |
More InformationNo publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT01552681 History of Changes |
| Other Study ID Numbers: | DAIT ASJ02 |
| Study First Received: | March 9, 2012 |
| Last Updated: | February 25, 2014 |
| Health Authority: |
United States: Food and Drug Administration http://www.clinicaltrials.gov/ct2/show/NCT01552681?term=sjogrens&rank=20 |