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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00074373|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2003
Last Update Posted : November 5, 2019
|Condition or disease||Intervention/treatment|
|Neonatal Lupus Systemic Lupus Erythematosus Sjogren's Syndrome Congenital Heart Block||Other: No intervention; observational|
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|
|Actual Enrollment :||100 participants|
|Official Title:||The Research Registry for Neonatal Lupus|
|Study Start Date :||September 1994|
|Actual Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||January 2020|
human beings of all sexes, ages, and health statuses
Other: No intervention; observational
Other Name: The study is observational
- means of curing and/or preventing neonatal lupus [ Time Frame: ongoing ]means of curing and/or preventing neonatal lupus
- identification of pathogenesis of neonatal lupus [ Time Frame: ongoing ]identification of pathogenesis of neonatal lupus
Biospecimen Retention: Samples With DNA
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
|United States, New York|
|Jill P. Buyon, MD|
|New York, New York, United States, 10016|
|Study Director:||Jill P. Buyon, MD||NYU Medical Center, NYU School of Medicine|