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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 : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date December 11, 2003
First Posted Date December 12, 2003
Last Update Posted Date November 4, 2020
Study Start Date September 1994
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2013)
means of curing and/or preventing neonatal lupus [ Time Frame: ongoing ]
means of curing and/or preventing neonatal lupus
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 9, 2013)
identification of pathogenesis of neonatal lupus [ Time Frame: ongoing ]
identification of pathogenesis of neonatal lupus
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Research Registry for Neonatal Lupus
Official Title The Research Registry for Neonatal Lupus
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
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.
Condition
  • Neonatal Lupus
  • Systemic Lupus Erythematosus
  • Sjogren's Syndrome
  • Congenital Heart Block
Intervention Other: No intervention; observational
Other Name: The study is observational
Study Groups/Cohorts human beings
human beings of all sexes, ages, and health statuses
Intervention: Other: No intervention; observational
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 4, 2019)
100
Original Enrollment
 (submitted: June 23, 2005)
500
Estimated Study Completion Date January 2025
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Zoey Smith 212-263-0743 zoey.smith@nyumc.org
Contact: Jill Buyon, M.D. 212-263-0746 jill.buyon@nyumc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00074373
Other Study ID Numbers 09-0289
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party NYU Langone Health
Study Sponsor NYU Langone Health
Collaborators Not Provided
Investigators
Study Director: Jill P. Buyon, MD NYU Medical Center, NYU School of Medicine
PRS Account NYU Langone Health
Verification Date November 2020