Neonatal LupusNCT00074373
The Research Registry for Neonatal Lupus
An observational study of Neonatal Lupus and Systemic Lupus Erythematosus, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neonatal Lupus, Systemic Lupus Erythematosus, Sjogren's Syndrome
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2010to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- No intervention; observational
- Keywords
- Anti-SSA/Ro Antibodies, Anti-SSB/La Antibodies
- Medical subject headings
- Neonatal Systemic lupus erythematosus, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Congenital heart block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; observationalOther
Also called The study is observational
| Study group | Role | What they receive |
|---|---|---|
| human beings | human beings of all sexes, ages, and health statuses Receives: Other: No intervention; observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
means of curing and/or preventing neonatal lupus
means of curing and/or preventing neonatal lupus
Measured: ongoing
Secondary outcomes (1)
identification of pathogenesis of neonatal lupus
identification of pathogenesis of neonatal lupus
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2003 (estimated)
- Study start27 May 2010
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for Neonatal LupusStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill P. Buyon, MD, Study director, NYU Medical Center, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074373
- Sponsor's protocol ID
- 09-0289
- Status last verified
- Aug 2023
- First submitted
- 11 Dec 2003
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. doi: 10.1080/0891693031000067340.
PubMed 12765470Solomon 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. doi: 10.1191/0961203303lu425xx. No abstract available.
PubMed 12945727Askanase 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. doi: 10.1002/1529-0131(200201)46:13.0.CO;2-6. No abstract available.
PubMed 11817601Askanase 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. doi: 10.1191/0961203302lu173oa.
PubMed 11999879Martin 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. doi: 10.1002/art.10638.
PubMed 12355485Neiman 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. doi: 10.1067/mpd.2000.109108.
PubMed 11060534Buyon 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. doi: 10.1016/s0735-1097(98)00161-2.
PubMed 9626848Clancy RM, Buyon JP. Autoimmune-associated congenital heart block: dissecting the cascade from immunologic insult to relentless fibrosis. Anat Rec A Discov Mol Cell Evol Biol. 2004 Oct;280(2):1027-35. doi: 10.1002/ar.a.20072.
PubMed 15368347Clancy RM, Buyon JP. More to death than dying: apoptosis in the pathogenesis of SSA/Ro-SSB/La-associated congenital heart block. Rheum Dis Clin North Am. 2004 Aug;30(3):589-602, x. doi: 10.1016/j.rdc.2004.04.013.
PubMed 15261343Clancy RM, Kapur RP, Molad Y, Askanase AD, Buyon JP. Immunohistologic evidence supports apoptosis, IgG deposition, and novel macrophage/fibroblast crosstalk in the pathologic cascade leading to congenital heart block. Arthritis Rheum. 2004 Jan;50(1):173-82. doi: 10.1002/art.11430.
PubMed 14730614Hu K, Qu Y, Yue Y, Boutjdir M. Functional basis of sinus bradycardia in congenital heart block. Circ Res. 2004 Mar 5;94(4):e32-8. doi: 10.1161/01.RES.0000121566.01778.06. Epub 2004 Feb 12.
PubMed 14963005Clancy RM, Backer CB, Yin X, Chang MW, Cohen SR, Lee LA, Buyon JP. Genetic association of cutaneous neonatal lupus with HLA class II and tumor necrosis factor alpha: implications for pathogenesis. Arthritis Rheum. 2004 Aug;50(8):2598-603. doi: 10.1002/art.20442.
PubMed 15334474Gordon P, Khamashta MA, Rosenthal E, Simpson JM, Sharland G, Brucato A, Franceschini F, De Bosschere K, Meheus L, Meroni PL, Hughes GR, Buyon J. Anti-52 kDa Ro, anti-60 kDa Ro, and anti-La antibody profiles in neonatal lupus. J Rheumatol. 2004 Dec;31(12):2480-7.
PubMed 15570655Glickstein J, Buyon J, Kim M, Friedman D; PRIDE investigators. The fetal Doppler mechanical PR interval: a validation study. Fetal Diagn Ther. 2004 Jan-Feb;19(1):31-4. doi: 10.1159/000074256.
PubMed 14646414Tran HB, Cavill D, Buyon JP, Gordon TP. Intravenous immunoglobulin and placental transport of anti-Ro/La antibodies: comment on the letter by Kaaja and Julkunen. Arthritis Rheum. 2004 Jan;50(1):337-8; author reply 338. doi: 10.1002/art.11498. No abstract available.
PubMed 14730639
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research Registry for Neonatal Lupus
- ClinicalTrials.gov ID
- NCT00074373
- Acronym / sponsor ID
- 09-0289
- Keywords
- Anti-SSA/Ro Antibodies, Anti-SSB/La Antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 27 May 2010 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| human beings | – | Other: No intervention; observationalhuman beings of all sexes, ages, and health statuses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention; observationalAlso: The study is observational | Other | human beings |
Primary outcome
means of curing and/or preventing neonatal lupus
Time frame: ongoing
means of curing and/or preventing neonatal lupus
1 secondary outcome
identification of pathogenesis of neonatal lupus
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Background: PubMed 12765470Buyon 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. doi: 10.1080/0891693031000067340.
- Background: PubMed 12945727Solomon 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. doi: 10.1191/0961203303lu425xx. No abstract available.
- Background: PubMed 11817601Askanase 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. doi: 10.1002/1529-0131(200201)46:13.0.CO;2-6. No abstract available.
- Background: PubMed 11999879Askanase 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. doi: 10.1191/0961203302lu173oa.
- Background: PubMed 12355485Martin 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. doi: 10.1002/art.10638.
- Background: PubMed 11060534Neiman 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. doi: 10.1067/mpd.2000.109108.
- Background: PubMed 9626848Buyon 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. doi: 10.1016/s0735-1097(98)00161-2.
- Background: PubMed 15368347Clancy RM, Buyon JP. Autoimmune-associated congenital heart block: dissecting the cascade from immunologic insult to relentless fibrosis. Anat Rec A Discov Mol Cell Evol Biol. 2004 Oct;280(2):1027-35. doi: 10.1002/ar.a.20072.
- Background: PubMed 15261343Clancy RM, Buyon JP. More to death than dying: apoptosis in the pathogenesis of SSA/Ro-SSB/La-associated congenital heart block. Rheum Dis Clin North Am. 2004 Aug;30(3):589-602, x. doi: 10.1016/j.rdc.2004.04.013.
- Background: PubMed 14730614Clancy RM, Kapur RP, Molad Y, Askanase AD, Buyon JP. Immunohistologic evidence supports apoptosis, IgG deposition, and novel macrophage/fibroblast crosstalk in the pathologic cascade leading to congenital heart block. Arthritis Rheum. 2004 Jan;50(1):173-82. doi: 10.1002/art.11430.
- Background: PubMed 14963005Hu K, Qu Y, Yue Y, Boutjdir M. Functional basis of sinus bradycardia in congenital heart block. Circ Res. 2004 Mar 5;94(4):e32-8. doi: 10.1161/01.RES.0000121566.01778.06. Epub 2004 Feb 12.
- Background: PubMed 15334474Clancy RM, Backer CB, Yin X, Chang MW, Cohen SR, Lee LA, Buyon JP. Genetic association of cutaneous neonatal lupus with HLA class II and tumor necrosis factor alpha: implications for pathogenesis. Arthritis Rheum. 2004 Aug;50(8):2598-603. doi: 10.1002/art.20442.
- Research Registry for Neonatal Lupus Facebook PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill P. Buyon, MD study director
NYU Medical Center, NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Lupus and Systemic Lupus Erythematosus, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
means of curing and/or preventing neonatal lupus (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00074373, which also lists 60 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.