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The Research Registry for Neonatal Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00074373
Recruitment Status : Recruiting
First Posted : December 12, 2003
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Neonatal Lupus Systemic Lupus Erythematosus Sjogren's Syndrome Congenital Heart Block Other: No intervention; 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Research Registry for Neonatal Lupus
Study Start Date : September 1994
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
human beings
human beings of all sexes, ages, and health statuses
 Other: No intervention; observational
Other Name: The study is observational


Outcome Measures
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Primary Outcome Measures :
  1. means of curing and/or preventing neonatal lupus [ Time Frame: ongoing ]
    means of curing and/or preventing neonatal lupus


Secondary Outcome Measures :
  1. identification of pathogenesis of neonatal lupus [ Time Frame: ongoing ]
    identification of pathogenesis of neonatal lupus


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074373


Contacts
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Contact: Mala Masson 212-263-0372 mala.masson@nyulangone.org
Contact: Jill Buyon, M.D. 212-263-0746 jill.buyon@nyulangone.org

Locations
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United States, New York
Jill P. Buyon, MD Recruiting
New York, New York, United States, 10016
Contact: Mala Masson    212-263-0372    mala.masson@nyulangone.org   
Contact: Jill Buyon, M.D.    212-263-0746    jill.buyon@nyulangone.org   
Principal Investigator: Jill P. Buyon, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Study Director: Jill P. Buyon, MD NYU Medical Center, NYU School of Medicine
More Information
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Additional Information:

Publications:

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00074373    
Other Study ID Numbers: 09-0289
First Posted: December 12, 2003    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Anti-SSA/Ro Antibodies
Anti-SSB/La Antibodies
Additional relevant MeSH terms:
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Sjogren's Syndrome
Heart Block
Lupus Erythematosus, Systemic
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
Cardiac Conduction System Disease
Pathologic Processes