Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
100 participants
Study Classification
OBSERVATIONAL
Study Start Date
2010-05-27
Study Completion Date
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preventive IVIG Therapy for Congenital Heart Block
NCT00460928
Congenital Heart Block
Neonatal Lupus
Autoantibody-associated Heart Block
COMPLETED
EARLY_PHASE1
Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus
NCT00004663
Systemic Lupus Erythematosus
COMPLETED
Treatment and Clinical Outcomes Among SLE Patients in Pregnancy
NCT04976465
Systemic Lupus Erythematosus
Pregnancy Related
RECRUITING
PHASE1
Duke Autoimmunity in Pregnancy Registry
NCT00513591
Pregnancy
Systemic Lupus Erythematosus
Cutaneous Lupus
+3 more
COMPLETED
Role of the Neonatal Fc Receptor for IgG in the Pathophysiology of Lupus
NCT03896373
Lupus Erythematosus, Systemic
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Neonatal Lupus
Systemic Lupus Erythematosus
Sjogren's Syndrome
Congenital Heart Block
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
human beings
human beings of all sexes, ages, and health statuses
No intervention; observational
Intervention Type
OTHER
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention; observational
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
The study is observational
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NYU Langone Health
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jill P. Buyon, MD
Role: STUDY_DIRECTOR
NYU Medical Center, NYU School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jill P. Buyon, MD
New York, New York, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
Solomon 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.
Reference Type
BACKGROUND
Askanase 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.
Reference Type
BACKGROUND
Askanase 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.
Reference Type
BACKGROUND
Martin 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.
Reference Type
BACKGROUND
Neiman 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.
Reference Type
BACKGROUND
Buyon 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.
Reference Type
BACKGROUND
Clancy 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.
Reference Type
BACKGROUND
Clancy 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.
Reference Type
BACKGROUND
Clancy 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.
Reference Type
BACKGROUND
Hu 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.
Reference Type
BACKGROUND
Clancy 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.
Reference Type
BACKGROUND
Gordon 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.
Reference Type
BACKGROUND
Glickstein 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.
Reference Type
BACKGROUND
Tran 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.
Reference Type
BACKGROUND
Buyon JP, Rupel A, Clancy RM. Neonatal lupus syndromes. Lupus. 2004;13(9):705-12. doi: 10.1191/0961203304lu2008oa.
Reference Type
BACKGROUND
Neufing PJ, Clancy RM, Jackson MW, Tran HB, Buyon JP, Gordon TP. Exposure and binding of selected immunodominant La/SSB epitopes on human apoptotic cells. Arthritis Rheum. 2005 Dec;52(12):3934-42. doi: 10.1002/art.21486.
Reference Type
BACKGROUND
Clancy RM, Buyon JP, Ikeda K, Nozawa K, Argyle DA, Friedman DM, Chan EK. Maternal antibody responses to the 52-kd SSA/RO p200 peptide and the development of fetal conduction defects. Arthritis Rheum. 2005 Oct;52(10):3079-86. doi: 10.1002/art.21289.
Reference Type
BACKGROUND
Buyon JP, Clancy RM. Autoantibody-associated congenital heart block: TGFbeta and the road to scar. Autoimmun Rev. 2005 Jan;4(1):1-7. doi: 10.1016/j.autrev.2004.04.003.
Reference Type
BACKGROUND
Kamel R, Eftekhari P, Clancy R, Buyon JP, Hoebeke J. Autoantibodies against the serotoninergic 5-HT4 receptor and congenital heart block: a reassessment. J Autoimmun. 2005 Aug;25(1):72-6. doi: 10.1016/j.jaut.2005.04.005.
Reference Type
BACKGROUND
Buyon JP, Askanase AD, Kim MY, Copel JA, Friedman DM. Identifying an early marker for congenital heart block: when is a long PR interval too long? Comment on the article by Sonesson et al. Arthritis Rheum. 2005 Apr;52(4):1341-2. doi: 10.1002/art.20971. No abstract available.
Reference Type
BACKGROUND
Buyon JP, Clancy RM. Neonatal lupus: basic research and clinical perspectives. Rheum Dis Clin North Am. 2005 May;31(2):299-313, vii. doi: 10.1016/j.rdc.2005.01.010.
Reference Type
BACKGROUND
Stea EA, Routsias JG, Clancy RM, Buyon JP, Moutsopoulos HM, Tzioufas AG. Anti-La/SSB antiidiotypic antibodies in maternal serum: a marker of low risk for neonatal lupus in an offspring. Arthritis Rheum. 2006 Jul;54(7):2228-34. doi: 10.1002/art.21954.
Reference Type
BACKGROUND
Askanase AD, Iloh I, Buyon JP. Hypothyroidism and antithyroglobulin and antithyroperoxidase antibodies in the pathogenesis of autoimmune associated congenital heart block. J Rheumatol. 2006 Oct;33(10):2099. No abstract available.
Reference Type
BACKGROUND
Bachmann MP, Bartsch H, Gross JK, Maier SM, Gross TF, Workman JL, James JA, Farris AD, Jung B, Franke C, Conrad K, Schmitz M, Buttner C, Buyon JP, Semsei I, Harley JB, Rieber EP. Autoimmunity as a result of escape from RNA surveillance. J Immunol. 2006 Aug 1;177(3):1698-707. doi: 10.4049/jimmunol.177.3.1698.
Reference Type
BACKGROUND
Clancy RM, Neufing PJ, Zheng P, O'Mahony M, Nimmerjahn F, Gordon TP, Buyon JP. Impaired clearance of apoptotic cardiocytes is linked to anti-SSA/Ro and -SSB/La antibodies in the pathogenesis of congenital heart block. J Clin Invest. 2006 Sep;116(9):2413-22. doi: 10.1172/JCI27803. Epub 2006 Aug 10.
Reference Type
BACKGROUND
Clancy RM, Zheng P, O'Mahony M, Izmirly P, Zavadil J, Gardner L, Buyon JP. Role of hypoxia and cAMP in the transdifferentiation of human fetal cardiac fibroblasts: implications for progression to scarring in autoimmune-associated congenital heart block. Arthritis Rheum. 2007 Dec;56(12):4120-31. doi: 10.1002/art.23061.
Reference Type
BACKGROUND
Izmirly PM, Rivera TL, Buyon JP. Neonatal lupus syndromes. Rheum Dis Clin North Am. 2007 May;33(2):267-85, vi. doi: 10.1016/j.rdc.2007.02.005.
Reference Type
BACKGROUND
Friedman DM, Rupel A, Buyon JP. Epidemiology, etiology, detection, and treatment of autoantibody-associated congenital heart block in neonatal lupus. Curr Rheumatol Rep. 2007 May;9(2):101-8. doi: 10.1007/s11926-007-0003-4.
Reference Type
BACKGROUND
Rivera TL, Izmirly PM, Birnbaum BK, Byrne P, Brauth JB, Katholi M, Kim MY, Fischer J, Clancy RM, Buyon JP. Disease progression in mothers of children enrolled in the Research Registry for Neonatal Lupus. Ann Rheum Dis. 2009 Jun;68(6):828-35. doi: 10.1136/ard.2008.088054. Epub 2008 Jul 14.
Reference Type
BACKGROUND
Strandberg L, Winqvist O, Sonesson SE, Mohseni S, Salomonsson S, Bremme K, Buyon JP, Julkunen H, Wahren-Herlenius M. Antibodies to amino acid 200-239 (p200) of Ro52 as serological markers for the risk of developing congenital heart block. Clin Exp Immunol. 2008 Oct;154(1):30-7. doi: 10.1111/j.1365-2249.2008.03732.x. Epub 2008 Aug 22.
Reference Type
BACKGROUND
Buyon JP, Brucato A, Friedman DM. What's in a name? Ann Rheum Dis. 2008 May;67(5):732; discussion 732. doi: 10.1136/ard.2007.082693. No abstract available.
Reference Type
BACKGROUND
Buyon JP, Clancy RM. Dying right to live longer: positing apoptosis as a link between maternal autoantibodies and congenital heart block. Lupus. 2008 Feb;17(2):86-90. doi: 10.1177/0961203307085115.
Reference Type
BACKGROUND
Niewold TB, Rivera TL, Buyon JP, Crow MK. Serum type I interferon activity is dependent on maternal diagnosis in anti-SSA/Ro-positive mothers of children with neonatal lupus. Arthritis Rheum. 2008 Feb;58(2):541-6. doi: 10.1002/art.23191.
Reference Type
BACKGROUND
Friedman DM, Kim MY, Copel JA, Davis C, Phoon CK, Glickstein JS, Buyon JP; PRIDE Investigators. Utility of cardiac monitoring in fetuses at risk for congenital heart block: the PR Interval and Dexamethasone Evaluation (PRIDE) prospective study. Circulation. 2008 Jan 29;117(4):485-93. doi: 10.1161/CIRCULATIONAHA.107.707661. Epub 2008 Jan 14.
Reference Type
BACKGROUND
Llanos C, Izmirly PM, Katholi M, Clancy RM, Friedman DM, Kim MY, Buyon JP. Recurrence rates of cardiac manifestations associated with neonatal lupus and maternal/fetal risk factors. Arthritis Rheum. 2009 Oct;60(10):3091-7. doi: 10.1002/art.24768.
Reference Type
BACKGROUND
Buyon JP, Clancy RM, Friedman DM. Autoimmune associated congenital heart block: integration of clinical and research clues in the management of the maternal / foetal dyad at risk. J Intern Med. 2009 Jun;265(6):653-62. doi: 10.1111/j.1365-2796.2009.02100.x.
Reference Type
BACKGROUND
Buyon JP, Clancy RM, Friedman DM. Cardiac manifestations of neonatal lupus erythematosus: guidelines to management, integrating clues from the bench and bedside. Nat Clin Pract Rheumatol. 2009 Mar;5(3):139-48. doi: 10.1038/ncprheum1018.
Reference Type
BACKGROUND
Friedman DM, Kim MY, Copel JA, Llanos C, Davis C, Buyon JP. Prospective evaluation of fetuses with autoimmune-associated congenital heart block followed in the PR Interval and Dexamethasone Evaluation (PRIDE) Study. Am J Cardiol. 2009 Apr 15;103(8):1102-6. doi: 10.1016/j.amjcard.2008.12.027. Epub 2009 Mar 4.
Reference Type
BACKGROUND
Llanos C, Chan EK, Li S, Abadal GX, Izmirly P, Byrne C, Clancy RM, Buyon JP. Antibody reactivity to alpha-enolase in mothers of children with congenital heart block. J Rheumatol. 2009 Mar;36(3):565-9. doi: 10.3899/jrheum.080860. Epub 2009 Feb 4.
Reference Type
BACKGROUND
Buyon JP. Updates on lupus and pregnancy. Bull NYU Hosp Jt Dis. 2009;67(3):271-5.
Reference Type
BACKGROUND
Briassouli P, Komissarova EV, Clancy RM, Buyon JP. Role of the urokinase plasminogen activator receptor in mediating impaired efferocytosis of anti-SSA/Ro-bound apoptotic cardiocytes: Implications in the pathogenesis of congenital heart block. Circ Res. 2010 Aug 6;107(3):374-87. doi: 10.1161/CIRCRESAHA.109.213629. Epub 2010 Jun 17.
Reference Type
BACKGROUND
Clancy RM, Alvarez D, Komissarova E, Barrat FJ, Swartz J, Buyon JP. Ro60-associated single-stranded RNA links inflammation with fetal cardiac fibrosis via ligation of TLRs: a novel pathway to autoimmune-associated heart block. J Immunol. 2010 Feb 15;184(4):2148-55. doi: 10.4049/jimmunol.0902248. Epub 2010 Jan 20.
Reference Type
BACKGROUND
Clancy RM, Marion MC, Kaufman KM, Ramos PS, Adler A; International Consortium on Systemic Lupus Erythematosus Genetics; Harley JB, Langefeld CD, Buyon JP. Identification of candidate loci at 6p21 and 21q22 in a genome-wide association study of cardiac manifestations of neonatal lupus. Arthritis Rheum. 2010 Nov;62(11):3415-24. doi: 10.1002/art.27658.
Reference Type
BACKGROUND
Askanase AD, Izmirly PM, Katholi M, Mumtaz J, Buyon JP. Frequency of neuro-psychiatric dysfunction in anti-SSA/SSB exposed children with and without neonatal lupus. Lupus. 2010 Mar;19(3):300-6. doi: 10.1177/0961203309354542. Epub 2009 Dec 14.
Reference Type
BACKGROUND
Friedman DM, Llanos C, Izmirly PM, Brock B, Byron J, Copel J, Cummiskey K, Dooley MA, Foley J, Graves C, Hendershott C, Kates R, Komissarova EV, Miller M, Pare E, Phoon CK, Prosen T, Reisner D, Ruderman E, Samuels P, Yu JK, Kim MY, Buyon JP. Evaluation of fetuses in a study of intravenous immunoglobulin as preventive therapy for congenital heart block: Results of a multicenter, prospective, open-label clinical trial. Arthritis Rheum. 2010 Apr;62(4):1138-46. doi: 10.1002/art.27308.
Reference Type
BACKGROUND
Izmirly PM, Llanos C, Lee LA, Askanase A, Kim MY, Buyon JP. Cutaneous manifestations of neonatal lupus and risk of subsequent congenital heart block. Arthritis Rheum. 2010 Apr;62(4):1153-7. doi: 10.1002/art.27333.
Reference Type
BACKGROUND
Karnabi E, Qu Y, Wadgaonkar R, Mancarella S, Yue Y, Chahine M, Clancy RM, Buyon JP, Boutjdir M. Congenital heart block: identification of autoantibody binding site on the extracellular loop (domain I, S5-S6) of alpha(1D) L-type Ca channel. J Autoimmun. 2010 Mar;34(2):80-6. doi: 10.1016/j.jaut.2009.06.005. Epub 2009 Jul 28.
Reference Type
BACKGROUND
Reynolds HR, Buyon J, Kim M, Rivera TL, Izmirly P, Tunick P, Clancy RM. Association of plasma soluble E-selectin and adiponectin with carotid plaque in patients with systemic lupus erythematosus. Atherosclerosis. 2010 Jun;210(2):569-74. doi: 10.1016/j.atherosclerosis.2009.12.007. Epub 2009 Dec 16.
Reference Type
BACKGROUND
Saxena A, McDonnell E, Ramos PS, Sajuthi S, Marion MC, Langefeld CD, Buyon JP, Clancy RM. Preferential transmission of genetic risk variants of candidate loci at 6p21 from asymptomatic grandparents to mothers of children with neonatal lupus. Arthritis Rheum. 2012 Mar;64(3):931-9. doi: 10.1002/art.33366.
Reference Type
BACKGROUND
Izmirly PM, Saxena A, Kim MY, Wang D, Sahl SK, Llanos C, Friedman D, Buyon JP. Maternal and fetal factors associated with mortality and morbidity in a multi-racial/ethnic registry of anti-SSA/Ro-associated cardiac neonatal lupus. Circulation. 2011 Nov 1;124(18):1927-35. doi: 10.1161/CIRCULATIONAHA.111.033894. Epub 2011 Oct 3.
Reference Type
BACKGROUND
Briassouli P, Rifkin D, Clancy RM, Buyon JP. Binding of anti-SSA antibodies to apoptotic fetal cardiocytes stimulates urokinase plasminogen activator (uPA)/uPA receptor-dependent activation of TGF-beta and potentiates fibrosis. J Immunol. 2011 Nov 15;187(10):5392-401. doi: 10.4049/jimmunol.1101288. Epub 2011 Oct 17.
Reference Type
BACKGROUND
Routsias JG, Kyriakidis NC, Friedman DM, Llanos C, Clancy R, Moutsopoulos HM, Buyon J, Tzioufas AG. Association of the idiotype:antiidiotype antibody ratio with the efficacy of intravenous immunoglobulin treatment for the prevention of recurrent autoimmune-associated congenital heart block. Arthritis Rheum. 2011 Sep;63(9):2783-9. doi: 10.1002/art.30464.
Reference Type
BACKGROUND
Alvarez D, Briassouli P, Clancy RM, Zavadil J, Reed JH, Abellar RG, Halushka M, Fox-Talbot K, Barrat FJ, Buyon JP. A novel role of endothelin-1 in linking Toll-like receptor 7-mediated inflammation to fibrosis in congenital heart block. J Biol Chem. 2011 Sep 2;286(35):30444-30454. doi: 10.1074/jbc.M111.263657. Epub 2011 Jul 5.
Reference Type
BACKGROUND
Reed JH, Clancy RM, Purcell AW, Kim MY, Gordon TP, Buyon JP. beta2-glycoprotein I and protection from anti-SSA/Ro60-associated cardiac manifestations of neonatal lupus. J Immunol. 2011 Jul 1;187(1):520-6. doi: 10.4049/jimmunol.1100122. Epub 2011 May 20.
Reference Type
BACKGROUND
Reed JH, Clancy RM, Lee KH, Saxena A, Izmirly PM, Buyon JP. Umbilical cord blood levels of maternal antibodies reactive with p200 and full-length Ro 52 in the assessment of risk for cardiac manifestations of neonatal lupus. Arthritis Care Res (Hoboken). 2012 Sep;64(9):1373-81. doi: 10.1002/acr.21704.
Reference Type
BACKGROUND
Cherian TS, Kariuki SN, Franek BS, Buyon JP, Clancy RM, Niewold TB. Brief Report: IRF5 systemic lupus erythematosus risk haplotype is associated with asymptomatic serologic autoimmunity and progression to clinical autoimmunity in mothers of children with neonatal lupus. Arthritis Rheum. 2012 Oct;64(10):3383-7. doi: 10.1002/art.34571.
Reference Type
BACKGROUND
Izmirly PM, Buyon JP, Saxena A. Neonatal lupus: advances in understanding pathogenesis and identifying treatments of cardiac disease. Curr Opin Rheumatol. 2012 Sep;24(5):466-72. doi: 10.1097/BOR.0b013e328356226b.
Reference Type
BACKGROUND
Ramos PS, Marion MC, Langefeld CD; International Consortium on Systemic Lupus Erythematosus Genetics; Buyon JP, Clancy RM. Brief report: enrichment of associations in genes with fibrosis, apoptosis, and innate immunity functions with cardiac manifestations of neonatal lupus. Arthritis Rheum. 2012 Dec;64(12):4060-5. doi: 10.1002/art.34663.
Reference Type
BACKGROUND
Reed JH, Jain M, Lee K, Kandimalla ER, Faridi MH, Buyon JP, Gupta V, Clancy RM. Complement receptor 3 influences toll-like receptor 7/8-dependent inflammation: implications for autoimmune diseases characterized by antibody reactivity to ribonucleoproteins. J Biol Chem. 2013 Mar 29;288(13):9077-83. doi: 10.1074/jbc.M112.403303. Epub 2013 Feb 5.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
https://www.facebook.com/pages/Research-Registry-For-Neonatal-Lupus/212655652139338
Research Registry for Neonatal Lupus Facebook Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09-0289
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Fetal-Hope Study: Home Monitoring of Fetal Heart Rate in SSA+ Pregnant Women
NCT05958446
RECRUITING
Research Accelerated by You Lupus Registry
NCT06927219
RECRUITING
Lupus Cohort--Thrombotic Events and Coronary Artery Disease
NCT00005436
COMPLETED
Identifying New Therapeutic Targets for Lupus Treatment
NCT03921398
COMPLETED
Study of Systemic Lupus Erythematosus
NCT00001372
RECRUITING
Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases
NCT04276701
RECRUITING
NA
Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus
NCT07148115
RECRUITING
Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis
NCT04449991
RECRUITING
NA
HLA Antibodies in Systemic Lupus Erythematosus
NCT06921239
RECRUITING
Duke Lupus Registry
NCT00512694
RECRUITING
Biocollection of Rare Pediatric-onset of Autoimmune and Autoinflammatory Diseases
NCT06435468
RECRUITING
NA
Neuropsycatric Disorders Among Children With Systemic Lupus Erythematosus in Sohag University Hospital
NCT06449794
RECRUITING
Systemic Lupus and Adverse Pregnancy Outcome
NCT03171103
UNKNOWN
A Study of Clinical Characteristics ,Risk Factors and Outcome of Lupus Nephritis Among Children With Systemic Lupus Erthromatousus in Sohag Univeristy Hospital
NCT06491602
RECRUITING
Drug Therapy in Lupus Nephropathy
NCT00001212
COMPLETED
PHASE2
Photoprovocation Testing in Subjects With Cutaneous Lupus
NCT01516788
COMPLETED
NA
Health-related Quality of Life Measure in Pediatric Lupus
NCT00280137
COMPLETED
Cardiac Imaging in Systemic Disorders: the ORACLES Registry
NCT07134166
NOT_YET_RECRUITING
T Regulatory Cells IN LUPUS NEPHRITIS
NCT06428539
NOT_YET_RECRUITING
Study of Neonatal IgG Fc Receptor Expression in Natural Killer T Cells Expressing an Invariant T Receptor : Implication in the Pathophysiology of Systemic Lupus
NCT05859191
RECRUITING
Safety and Efficacy of ONT01 in Lupus
NCT07107659
RECRUITING
EARLY_PHASE1
Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
NCT01470183
COMPLETED
Long Non Coding RNA in Complications of Systemic Lupus
NCT03185767
UNKNOWN
NA
Serologically Active, Clinically Stable Systemic Lupus Erythematosus
NCT00000421
COMPLETED
PHASE2
Dynamic Imaging of Variation in Lupus Nephritis
NCT03180021
COMPLETED