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The Research Registry for Neonatal Lupus

This study is currently recruiting participants.
Verified by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), March 2008

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00074373
  Purpose

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
Neonatal Lupus
Systemic Lupus Erythematosus
Sjogren's Syndrome
Congenital Heart Block

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

MedlinePlus related topics:   Lupus    Sjogren's Syndrome   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   The Research Registry for Neonatal Lupus

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood


Estimated Enrollment:   500
Study Start Date:   September 1994
Estimated Study Completion Date:   September 2009

Detailed Description:

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

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.


Criteria

Inclusion Criteria:

  • Mother with antibodies to SSA/Ro, SSB/La, or ribonucleoproteins (RNP) OR Child of mother with such antibodies who has neonatal lupus (congenital heart block, transient skin rash, and/or hepatic or hematologic manifestations) OR Father of neonatal lupus-affected child OR Maternal grandparents of neonatal lupus-affected child OR Maternal aunts and uncles of neonatal lupus-affected OR Unaffected siblings of neonatal lupus-affected child
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074373

Contacts
Contact: Peg Katholi     212-263-0743     peg.katholi@nyumc.org    

Locations
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            

Sponsors and Collaborators

Investigators
Study Director:     Jill P. Buyon, MD     NYU MEDICAL CENTER    
  More Information


Publications:
Buyon JP, Clancy RM. Neonatal lupus: review of proposed pathogenesis and clinical data from the US-based Research Registry for Neonatal Lupus. Autoimmunity. 2003 Feb;36(1):41-50. Review.
 
Solomon DG, Rupel A, Buyon JP. Birth order, gender and recurrence rate in autoantibody-associated congenital heart block: implications for pathogenesis and family counseling. Lupus. 2003;12(8):646-7. No abstract available.
 
Askanase AD, Miranda-Carus ME, Tang X, Katholi M, Buyon JP. The presence of IgG antibodies reactive with components of the SSA/Ro-SSB/La complex in human breast milk: implications in neonatal lupus. Arthritis Rheum. 2002 Jan;46(1):269-71. No abstract available.
 
Askanase AD, Friedman DM, Copel J, Dische MR, Dubin A, Starc TJ, Katholi MC, Buyon JP. Spectrum and progression of conduction abnormalities in infants born to mothers with anti-SSA/Ro-SSB/La antibodies. Lupus. 2002;11(3):145-51.
 
Martin V, Lee LA, Askanase AD, Katholi M, Buyon JP. Long-term followup of children with neonatal lupus and their unaffected siblings. Arthritis Rheum. 2002 Sep;46(9):2377-83.
 
Neiman AR, Lee LA, Weston WL, Buyon JP. Cutaneous manifestations of neonatal lupus without heart block: characteristics of mothers and children enrolled in a national registry. J Pediatr. 2000 Nov;137(5):674-80.
 
Buyon JP, Hiebert R, Copel J, Craft J, Friedman D, Katholi M, Lee LA, Provost TT, Reichlin M, Rider L, Rupel A, Saleeb S, Weston WL, Skovron ML. Autoimmune-associated congenital heart block: demographics, mortality, morbidity and recurrence rates obtained from a national neonatal lupus registry. J Am Coll Cardiol. 1998 Jun;31(7):1658-66.
 

Responsible Party:   NYU Medical Center ( Dr. Jill Buyon )
Study ID Numbers:   NIAMS-105
First Received:   December 11, 2003
Last Updated:   March 11, 2008
ClinicalTrials.gov Identifier:   NCT00074373
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Anti-SSA/Ro Antibodies  
Anti-SSB/La Antibodies  

Study placed in the following topic categories:
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
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Disease
Pathologic Processes
Immune System Diseases
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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