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Home > "T" Clinical Trials Conditions > The Research Registry for Neonatal Lupus  The Research Registry for Neonatal Lupus
The Research Registry for Neonatal Lupus
For Condition: Sjogren's Syndrome,Systemic Lupus Erythematosus,Neonatal lupus,Congenital heart block
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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.
Details: 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, 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. All information on the mother and her family is confidential; only non-identifying 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 send a record of their antibody status or a blood sample for antibody testing.
Eligibility:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Mothers and their affected and unaffected children are eligible for enrollment. Inclusion Criteria: - Mothers with antibodies to SSA/Ro, SSB/La, or ribonucleoproteins (RNP) - Child with neonatal lupus (congenital heart block, transient skin rash, and/or hepatic or hematologic manifestations)
Total Enrollment: 500
Location and Contact Information:
Overall Study Official:
JillBuyon, Principal Investigator, Hospital for Joint Diseases
Jill P. Buyon, MD *Recruiting*
New York City, New York, 10003
United States
Recruiting Peg Katholi 212-598-6514
Additional Information:
Study ID Numbers: NIAMS-105;
Study Start Date: September 1994
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074373
Other Neonatal Lupus Studies:
1. Potential of Transplanted Stem Cells to Mature into Salivary Gland and Cheek Cells
2. Six month clinical research study for patients with moderate or severe dry eye syndrome
3. Evaluation of Salivary Gland Dysfunction
4. Etanercept Therapy for Sjogren's Syndrome
5. The Functioning of Immune and Hormonal Systems in Patients with Sjogren's Syndrome and in Healthy Volunteers
Related Studies:
Other Neonatal lupus Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
The Research Registry for Neonatal Lupus
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