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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00074373 |
Women with lupus and other related disorders produce certain antibodies in the blood. Some women have these antibodies even if they have not yet developed symptoms of lupus or Sjogren's syndrome. When these women become pregnant, they may pass the antibodies to their infants. The infants may then develop a disease called neonatal lupus. The symptoms of neonatal lupus include an abnormally slow heart beat (heart block) and a skin rash. This registry collects information on women and infants affected by neonatal lupus as well as other family members who may be healthy.
Condition |
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Neonatal Lupus Systemic Lupus Erythematosus Sjogren's Syndrome Congenital Heart Block |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Research Registry for Neonatal Lupus |
Blood
Estimated Enrollment: | 500 |
Study Start Date: | September 1994 |
Estimated Study Completion Date: | September 2009 |
Neonatal lupus is a disease seen in babies born to mothers who have antibodies to SSA/Ro and/or SSB/La proteins. The mother may have systemic lupus erythematosus, Sjogren's syndrome, or be otherwise healthy. Heart block and a characteristic skin rash are the primary manifestations of neonatal lupus.
The Research Registry for Neonatal Lupus was initiated in 1994 to help basic scientists and clinicians better understand the cause of neonatal lupus and discover a cure. The Research Registry is a central repository of patient information, sera, and DNA. The Registry provides blood samples (kept anonymous) to scientists studying neonatal lupus. Information from the registry forms the basis of family counseling and tracks important data such as recurrence rates in subsequent pregnancies and the effects of treatments. The Research Registry also serves as an educational resource for women who are eager to learn about this disease.
Women with a child affected by neonatal lupus may enroll in the Registry. Women can be self referred or referred by their doctors. Siblings of women with a child affected by neonatal lupus, fathers and maternal grandparents of children with neonatal lupus, and unaffected siblings of a child with neonatal lupus are also invited to participate in this study. All information on the mother and her family is confidential; only nonidentifying information will be provided to researchers. Women interested in the registry will be sent articles and educational materials about neonatal lupus, a consent form for the Registry, and an enrollment questionnaire. Participants will be asked to sign a medical records release form. Participants will also be asked to donate a blood sample for antibody testing and DNA isolation.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Women with a child affected by neonatal lupus may enroll in the Registry. Siblings of women with a child affected by neonatal lupus, fathers and maternal grandparents of children with neonatal lupus, and unaffected siblings of a child with neonatal lupus are also invited to participate in this study.
Inclusion Criteria:
Contact: Peg Katholi | 212-263-0743 | peg.katholi@nyumc.org |
United States, New York | |
Jill P. Buyon, MD | Recruiting |
New York, New York, United States, 10016 | |
Contact: Peg Katholi 212-263-0743 peg.katholi@nyumc.org | |
Principal Investigator: Jill P. Buyon, MD |
Study Director: | Jill P. Buyon, MD | NYU MEDICAL CENTER |
Responsible Party: | NYU Medical Center ( Dr. Jill Buyon ) |
Study ID Numbers: | NIAMS-105 |
Study First Received: | December 11, 2003 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00074373 |
Health Authority: | United States: Federal Government |
Anti-SSA/Ro Antibodies Anti-SSB/La Antibodies |
Mouth Diseases Neonatal Systemic lupus erythematosus Heart Diseases Autoimmune Diseases Eye Diseases Joint Diseases Arthritis, Rheumatoid Lacrimal Apparatus Diseases Dry Eye Syndromes Rheumatic Diseases Xerostomia Congenital heart block |
Antibodies Lupus Erythematosus, Systemic Musculoskeletal Diseases Heart Block Arthritis Connective Tissue Diseases Sjogren's Syndrome Stomatognathic Diseases Salivary Gland Diseases Immunoglobulins Arrhythmias, Cardiac |
Disease Pathologic Processes Immune System Diseases Syndrome Cardiovascular Diseases |