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NCT00339261 · ClinicalTrials.gov registry record

Disease Progression and Activity in Patients With Systemic Lupus Erythematosus

A clinical trial of Lupus, sponsored by National Institute of Environmental Health Sciences (NIEHS).

Completed
Registry status
716
Enrollment target
1
Study location

NCT00339261 is a study of Lupus that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 716 participants, above the 230-participant average among 13 other Lupus trials with a reported enrollment target (211% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00339261, a study of Lupus, has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).

COMPLETED
Registry status
716 participants
Enrollment target
1
Study location

Study Summary

This study is a continuing follow-up of patients with systemic lupus erythematosus (SLE) and control subjects enrolled in the Carolina Lupus Study and the University of North Carolina (UNC) Lupus Nephritis Study. SLE is a severe, chronic, disabling autoimmune disease that significantly affects health and quality of life. The disease most often affects young to middle-aged adults, and therefore can also affect work and disability. There is currently little information on work-related disability related to SLE. The goals of the current study are to: * Determine health and work status of patients and controls in the Carolina Lupus Study and the UNC Lupus Nephritis Study; * Develop and test methods for obtaining disease data from university- and community-based physicians in the study area; * Examine the associations between sociodemographic, work-related factors, disease damage, and work disability among SLE patients and controls; and * Assess the role of demographic and socioeconomic factors, psychosocial attributes, and potentially modifiable behavior or environmental factors (e.g., smoking, occupational exposures, medication compliance) in disease damage measures, and in the increased severity of disease among African-American patients. Patients and control subjects enrolled in the Carolina Lupus Study and the University of North Carolina Lupus Nephritis Study are eligible for this protocol. Subjects will participate in a 30-minute telephone interview that includes questions related to their current health status, medical care utilization, work and disability issues, psychosocial attributes (e.g., helplessness, social support), and changes in environmental exposures since the previous follow-up interview in 2001. With the patients' permission, disease damaged will be assessed using a standardized form to be completed by the patients' physician or using information obtained from the patient's medical record.

Conditions Studied

Study Locations (1)

Maryland

  • National Institute of Environmental Health Sciences (NIEHS) - Bethesda

Trial Details

FieldValue
Enrollment Target 716 participants
Start Date 2003-12-16
Est. Completion 2006-10-26

What the Registry Record Tells You About NCT00339261

The ClinicalTrials.gov registry entry for NCT00339261 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 716 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 230-participant average among 13 other Lupus trials with a reported enrollment target (211% higher). The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lupus appearing as the primary indexed condition, and to 0 interventions.

NCT00339261 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00339261 about?

NCT00339261 is a clinical study titled "Disease Progression and Activity in Patients With Systemic Lupus Erythematosus". This study is a continuing follow-up of patients with systemic lupus erythematosus (SLE) and control subjects enrolled in the Carolina Lupus Study and the University of North Carolina (UNC) Lupus Nephritis Study. SLE is a severe, chronic, disabling autoimmune disease that significantly affects healt...

What is the current status of trial NCT00339261?

This trial is currently completed. The enrollment target is 716 participants. The study started on 2003-12-16. Estimated completion is 2006-10-26.

What conditions does trial NCT00339261 study?

This clinical trial studies the following conditions: Lupus.

Who is sponsoring clinical trial NCT00339261?

This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00339261 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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