The Research Registry for Neonatal Lupus

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Jill P. Buyon, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00074373
First received: December 11, 2003
Last updated: April 9, 2013
Last verified: April 2013
  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 Intervention
Neonatal Lupus
Systemic Lupus Erythematosus
Sjogren's Syndrome
Congenital Heart Block
Other: No intervention; observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Research Registry for Neonatal Lupus

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • means of curing and/or preventing neonatal lupus [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    means of curing and/or preventing neonatal lupus


Secondary Outcome Measures:
  • identification of pathogenesis of neonatal lupus [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    identification of pathogenesis of neonatal lupus


Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 500
Study Start Date: September 1994
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
human beings
human beings of all sexes, ages, and health statuses
Other: No intervention; observational
Other Name: The study is observational

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:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with a child affected by neonatal lupus, children affected by neonatal lupus, siblings of children affected by neonatal lupus, siblings of women with a child affected by neonatal lupus, fathers and maternal grandparents of children with neonatal lupus, and unaffected people to serve as controls are 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Zoey Smith 212-263-0743 zoey.smith@nyumc.org
Contact: Jill Buyon, M.D. 212-263-0746 jill.buyon@nyumc.org

Locations
United States, New York
Jill P. Buyon, MD Recruiting
New York, New York, United States, 10016
Contact: Zoey Smith    212-263-0743    zoey.smith@nyumc.org   
Contact: Jill Buyon, M.D.    212-263-0746    jill.buyon@nyumc.org   
Principal Investigator: Jill P. Buyon, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Director: Jill P. Buyon, MD NYU Medical Center, NYU School of Medicine
  More Information

Additional Information:
Publications:

Responsible Party: Jill P. Buyon, Director, Research Registry for Neonatal Lupus, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00074373     History of Changes
Other Study ID Numbers: NIAMS-105
Study First Received: December 11, 2003
Last Updated: April 9, 2013
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
Anti-SSA/Ro Antibodies
Anti-SSB/La Antibodies

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Sjogren's Syndrome
Heart Block
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014