NCT00460928

Brief Summary

Neonatal lupus (NL) is the name given to a group of conditions that can affect the babies of mothers who have certain autoantibodies against components of the body's cells that are called SSA/Ro and SSB/La. NL can appear as a temporary rash that usually goes away by the time the baby is 6 months old, or very rarely an abnormal blood or liver condition that also improves with time - or it can cause permanent and often life-threatening damage to the fetal heart, known as congenital heart block (CHB). In women with anti-Ro/La antibodies who are pregnant for the first time, only about 2% of the babies will develop CHB. But for a woman who has already had a child with CHB or NL rash, the risk of CHB in her next pregnancy is nearly 20%. Unfortunately, once complete (third degree) heart block has been unequivocally identified in a fetus, it has never been reversed with any of the therapies that have been tried to date. Our previous studies strongly indicate that scarring of the conduction system (the heart's own natural "pacemaker"), a consequence of inflammation triggered by the mother's antibodies, damages or even destroys the cells that allow the heart to beat at a normal rhythm. Instead, the damaged heart beats extremely slowly, to an extent that is fatal to nearly 20% of affected babies (with most deaths occurring as fetal demises). Nearly all surviving children with CHB require permanent implantation of a pacemaker device. Because it is so difficult to treat or repair the damaged heart, a high-priority strategy is to try to prevent the inflammatory process before irreversible scarring can occur. The aim of this clinical-based proposal is to determine whether treating the pregnant mother with intravenous immune globulin (IVIG) will prevent the development of CHB.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2007

Typical duration for early_phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2.2 years

First QC Date

April 13, 2007

Last Update Submit

September 26, 2019

Conditions

Congenital Heart BlockNeonatal LupusAutoantibody-associated Heart Block

Keywords

congenital heart blockneonatal lupussystemic lupus erythematosusSjogren syndromeautoantibodiesSSA/RoSSB/Laautoimmunitypregnancyintravenous immune globulinIVIGimmunoglobulin

Outcome Measures

Primary Outcomes (1)

  • 2nd or 3rd degree heart block

    1 Day

Secondary Outcomes (8)

  • Prolonged PR interval (>0.150 sec)

    1 Day

  • Sign of myocardial injury, w/o change in heart rate/rhythm

    1 Day

  • Echocardiographic density consistent with EFE

    1 Day

  • Fetal death

    1 Day

  • Rash consistent w neonatal lupus

    1 Day

  • +3 more secondary outcomes

Study Arms (1)

intravenous immune globulin (IVIG)

EXPERIMENTAL
Drug: intravenous immune globulin (IVIG)

Interventions

intravenous immune globulin (IVIG)DRUG
intravenous immune globulin (IVIG)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mother must currently have an intrauterine pregnancy of less than 12 weeks.
  • Mother must have antibodies to SSA/Ro and/or SSB/La (will be confirmed in the clinical immunology laboratory at the Principal Investigator's institution, the NYU-Hospital for Joint Diseases).
  • Mother can be asymptomatic or have any rheumatic disease (such as lupus, Sjogren syndrome or other).
  • Mother must have had a previous child with one of the following: (a) congenital heart block (any degree) documented by EKG if live birth and/or echocardiogram if fetal demise; (b) characteristic neonatal lupus rash confirmed by photograph revealing annular lesions (evaluated by the PI), dermatology note, and/or biopsy; (c) congenital heart block and rash.
  • Mother may be taking 20 mg prednisone per day or less.

You may not qualify if:

  • Mother does not have antibodies to either SSA/Ro or SSB/La.
  • Mother is taking greater than 20 mg prednisone per day.
  • Mother has any condition that would contraindicate the use of IVIG: (a) prior serious reaction to IVIG infusion; (b) known IgA deficiency; (c) intolerance of volume load, e.g., congestive heart failure; (d) nephrotic syndrome.
  • Identification in the fetus of any of the following structural lesions considered causal for congenital heart block: (a) atrioventricular septal defects; (b) single ventricle; (c) developmental tricuspid valve disease; (d) L-transposition of the great arteries; (e) heterotaxia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

New York University School of Medicine / NYU-Hospital for Joint Diseases

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

    PMID: 20391423DERIVED

Related Links

MeSH Terms

Conditions

Congenital heart blockNeonatal Systemic lupus erythematosusLupus Erythematosus, SystemicSjogren's SyndromeAutoimmune Diseases

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jill P. Buyon, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2007

First Posted

April 17, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

US(2)