Disease Progression and Activity in Patients With Systemic Lupus Erythematosus

NCT00339261 | Completed

• 2 other identifiers: 99990406304-E-N063
• Study Type: observational
• Target: 716
• Locations: 1 country
• Sites: 1

Brief 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

Lupus

Keywords

Cardiovascular; Renal; Autoimmune Disease; Genetics; Mortality

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* ELIGIBILITY CRITERIA: Participants to be contacted for this follow-up study are enrolled as part of the Disease Progression and Activity in the Carolina Lupus Study (Protocol Number OH97-E-N002) and the UNC Nephritis Study (Lupus Nephritis: Role of Environmental and Occupational Exposures, Protocol Number 01-E-N154). There will be no new subject enrollment. Participants were initially recruited from collaborating hospitals and physicians in North and South Carolina. Recruitment ended in July, 1999. Lupus most often affects young women and this is shown by the makeup of study participants. The demographics of the study participants is described in Table 2. Most CLU participants were born in North or South Carolina. More than half of CLU patients are African Americans. There is no involvement of special classes of subjects.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

National Institute of Environmental Health Sciences (NIEHS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Ward MM. Premature morbidity from cardiovascular and cerebrovascular diseases in women with systemic lupus erythematosus. Arthritis Rheum. 1999 Feb;42(2):338-46. doi: 10.1002/1529-0131(199902)42:23.0.CO;2-U.

  PMID: 10025929 BACKGROUND

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: December 16, 2003
• Study Completion: October 26, 2006
• Last Updated: July 2, 2017

Record last verified: 2006-10-26

Locations

US (1)