Levothyroxine in Pregnant SLE Patients

NCT01276782 | Withdrawn Phase 4 DMC

• 1 other identifier: NA_00042993
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The last two decades have witnessed an explosion of new research documenting the deleterious impact that thyroid disease has on pregnancy and the postpartum period, in relation to miscarriage preterm delivery intelligence quotient of the unborn child and health of the mother postpartum. Both subclinical hypothyroidism and thyroid antibody positivity in euthyroid women have been associated with miscarriage and preterm delivery. Approximately 5% of all pregnant women have a thyroid disorder. both spontaneous miscarriage and preterm delivery. Systemic lupus erythematosus (SLE), an autoimmune disorder of unknown etiology, has also been documented to negatively impact pregnancy. Women with Systemic lupus erythematosus (SLE)have increased rates of miscarriage and preterm delivery. Women with Systemic lupus erythematosus (SLE) also have increased rates of hypothyroidism and autoimmune thyroid disease (AITD, defined as the presence of thyroid antibodies with or without thyroid dysfunction). Preterm delivery (PTD), defined as birth prior to 37 weeks gestation, is the leading cause of neonatal mortality and morbidity in the United States. Although risk factors for preterm delivery exist, the majority of women have no known risk factors. Recently, both hypothyroidism and autoimmune thyroid disease have also been linked to preterm delivery. Given the increased prevalence of negative outcomes documented in pregnant women with thyroid disease, and the increased rates of hypothyroidism and Autoimmune thyroid disease in women with Systemic lupus erythematosus (SLE), the investigators determined that Autoimmune thyroid disease was associated with both preterm delivery and miscarriage. This has led to this application to begin a pilot randomized clinical trial of thyroxine in autoimmune thyroid disease in systemic lupus erythematosus pregnancy.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• preterm birth

  Delivery prior to 36 weeks

Secondary Outcomes (1)

• Miscarriage

  Loss of fetus before 20 weeks

Study Arms (1)

Pregnant SLE

PLACEBO COMPARATOR

Pregnant SLE patients with autoimmune thyroid antibodies will be randomized to levothyroxine or Placebo

Drug: Levothyroxine

Interventions

Levothyroxine DRUG

It is FDA approved drug for thyroid disease

Pregnant SLE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All SLE (Systemic Lupus Erythematosus) pregnant women (aged 18 - 45 years) before 14 weeks of gestation, with autoimmune thyroid antibodies

You may not qualify if:

• SLE (Systemic Lupus Erythematosus) patients already on levothyroxine. Those patients discovered to be hypothyroid who need levothyroxine as part of standard of care

Sponsors & Collaborators

• Johns Hopkins University: lead
• NYU Langone Health: collaborator
• Duke University: collaborator
• University of Chicago: collaborator
• Stanford University: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Michelle Petri, MD MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 13, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 10, 2015

Record last verified: 2015-09

Locations

US (1)