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NCT00000421 · ClinicalTrials.gov registry record · Phase 2

Serologically Active, Clinically Stable Systemic Lupus Erythematosus

A Phase 2 study of Systemic Lupus Erythematosus, sponsored by NYU Langone Health.

Completed
Registry status
Phase 2
Development phase
154
Enrollment target
3
Study locations

NCT00000421 is a Phase 2 study of Systemic Lupus Erythematosus that has completed, run by NYU Langone Health. The registered enrollment target is 154 participants, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (59% lower). The trial reports 3 study locations across 1 state.

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The verdict

NCT00000421, a Phase 2 study of Systemic Lupus Erythematosus, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 2
Development phase
154 participants
Enrollment target
3
Study locations

Study Summary

The first part of this study will use the database of a large, ongoing NIH-sponsored lupus study, Safety of Estrogen in Lupus Erythematosus National Assessment. We will examine the levels of a blood protein known as C3a in a series of patient blood samples to see if C3a levels predict lupus flares or are better than other blood tests, and therefore should be used more widely in managing lupus. In the second part of the study we will add or increase prednisone treatment on the basis of abnormalities in blood tests for C3a and dsDNA antibodies. Early treatment based on increases in C3a and dsDNA antibodies, before the patient develops physical signs of disease, may reduce lupus flares and, ultimately, the patient's total steroid exposure. We will follow study participants for 1 year on a monthly basis and do full physical examinations and laboratory evaluations. If C3a and dsDNA antibody levels are increased significantly above baseline levels while a patient is clinically stable, we will give the patient either prednisone or an inactive pill (placebo) for 1 month. We will follow these patients monthly to compare how often lupus flares occur in the two groups. This approach could provide a novel method of preventing lupus flares, using C3a as a sensitive predictor of flare.

Conditions Studied

Systemic Lupus Erythematosus

Interventions

  • DRUG Placebo
  • DRUG Prednisone

Study Locations (3)

New York

  • North Shore-Long Island Jewish Health System - New Hyde Park
  • Lenox Hill Hospital - New York
  • Office of Betty Diamond, M.D. - The Bronx

Trial Details

FieldValue
Enrollment Target 154 participants
Start Date 1997-09
Est. Completion 2003-08
Phase Phase 2

Sponsor

NYU Langone Health

1,164 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00000421

The ClinicalTrials.gov registry entry for NCT00000421 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (59% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00000421 reports 3 study locations spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00000421 about?

NCT00000421 is a clinical study titled "Serologically Active, Clinically Stable Systemic Lupus Erythematosus". The first part of this study will use the database of a large, ongoing NIH-sponsored lupus study, Safety of Estrogen in Lupus Erythematosus National Assessment. We will examine the levels of a blood protein known as C3a in a series of patient blood samples to see if C3a levels predict lupus flares o...

What is the current status of trial NCT00000421?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 1997-09. Estimated completion is 2003-08.

What conditions does trial NCT00000421 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus.

What interventions are being tested in trial NCT00000421?

The interventions under investigation include: Placebo (DRUG), Prednisone (DRUG).

Who is sponsoring clinical trial NCT00000421?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00000421 being conducted?

This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.