Systemic Lupus ErythematosusNCT00006134
Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture
An observational study of Systemic Lupus Erythematosus, run by National Center for Research Resources (NCRR) at 3 sites in United States.
Trial summary
OBJECTIVES: I. Continue yearly ascertainment visits of all patients of the established Lupus in Minority Populations: Nature vs Nurture (LUMINA) study cohort. II. Recruit into the LUMINA cohort newly diagnosed patients with systemic lupus erythematosus (SLE). III. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 1993to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- All systemic lupus erythematosus (SLE) patients currently constituting the established Lupus in Minority Populations: Nature vs Nurture (LUMINA) cohort OR New recruits meeting at least 4 of the 1997 American College of Rheumatology criteria for the classification of SLE
- Disease onset within the past 5 years
- African-American, Hispanic, or Caucasian Self stated, plus the same for all 4 grandparents
- No concurrent participation in any intervention studies
- Not pregnant
- Not mentally retarded
- No prisoners
- No other concurrent disability that would preclude study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
University of Texas Medical Branch
Galveston, Texas, 77555-0209
University of Texas Health Science Center - Houston
Houston, Texas, 77225
About this study
OBJECTIVES: I. Continue yearly ascertainment visits of all patients of the established Lupus in Minority Populations: Nature vs Nurture (LUMINA) study cohort.
II. Recruit into the LUMINA cohort newly diagnosed patients with systemic lupus erythematosus (SLE).
Read more
III. Determine the impact of additional major histocompatibility complex (MHC) and non-MHC genetic factors not previously examined, specifically tumor necrosis factor, mannose binding protein, interleukin-1 receptor antagonist, and bcl-2, on the course and outcome of SLE.
IV. Refine the assessment of those clinical and behavioral-cultural factors found to be important predictors of disease activity, damage, and functioning, thus far in these patients.
- Determine the relationships among disease activity, disease damage, and physical and mental functioning in these patients as the SLE progresses and the factors that predict them.
Read the detailed description
PROTOCOL OUTLINE: This is a parallel, follow up study of a natural history study. Patients are stratified according to ethnicity (Caucasian vs African-American vs Hispanic).
Patients are examined at baseline and then every 6 months thereafter in order to determine the relative impact of genetic, sociodemographic, and behavioral-cultural factors on disease outcome. Patients are assessed for the following outcome variables: disease activity by the Systemic Lupus Activity Measure (SLAM), disease damage by the Systemic Lupus International Collaborative Clinics Damage Index (SDI), and physical and mental functioning by the Medical Outcomes Study 36 Item Short-Form Health Survey (SF-36). Patients are also assessed for independent variables belonging to the following domains: socioeconomic-demographic, clinical, immunogenetic, and behavioral-cultural. Patients undergo genetic analysis utilizing polymerase chain reaction and electrophoresis to further study the immunogenetic domain and genetic markers that may be related to disease. Specifically, patients' blood is analyzed for tumor necrosis factor alpha, tumor necrosis factor beta, mannose binding protein, interleukin-1 receptor antagonist, and bcl-2.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Connective Tissue Diseases, Immune System Diseases, Communicable Diseases, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2000 (estimated)
- Study startSep 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Alabama at Birmingham
- Investigators
- Graciela S. Alarcon, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006134
- Sponsor's protocol ID
- 199/15328
- Other IDs
- UAB-GCRC-617
- Status last verified
- Dec 2003
- First submitted
- 3 Aug 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture
- ClinicalTrials.gov ID
- NCT00006134
- Acronym / sponsor ID
- 199/15328
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- University of Alabama at Birmingham
- Study start
- Sep 1993
- First posted
- 4 Aug 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES: I. Continue yearly ascertainment visits of all patients of the established Lupus in Minority Populations: Nature vs Nurture (LUMINA) study cohort.
II. Recruit into the LUMINA cohort newly diagnosed patients with systemic lupus erythematosus (SLE).
III. Determine the impact of additional major histocompatibility complex (MHC) and non-MHC genetic factors not previously examined, specifically tumor necrosis factor, mannose binding protein, interleukin-1 receptor antagonist, and bcl-2, on the course and outcome of SLE.
IV. Refine the assessment of those clinical and behavioral-cultural factors found to be important predictors of disease activity, damage, and functioning, thus far in these patients.
- Determine the relationships among disease activity, disease damage, and physical and mental functioning in these patients as the SLE progresses and the factors that predict them.
Detailed description
PROTOCOL OUTLINE: This is a parallel, follow up study of a natural history study. Patients are stratified according to ethnicity (Caucasian vs African-American vs Hispanic).
Patients are examined at baseline and then every 6 months thereafter in order to determine the relative impact of genetic, sociodemographic, and behavioral-cultural factors on disease outcome. Patients are assessed for the following outcome variables: disease activity by the Systemic Lupus Activity Measure (SLAM), disease damage by the Systemic Lupus International Collaborative Clinics Damage Index (SDI), and physical and mental functioning by the Medical Outcomes Study 36 Item Short-Form Health Survey (SF-36). Patients are also assessed for independent variables belonging to the following domains: socioeconomic-demographic, clinical, immunogenetic, and behavioral-cultural. Patients undergo genetic analysis utilizing polymerase chain reaction and electrophoresis to further study the immunogenetic domain and genetic markers that may be related to disease. Specifically, patients' blood is analyzed for tumor necrosis factor alpha, tumor necrosis factor beta, mannose binding protein, interleukin-1 receptor antagonist, and bcl-2.
Study design
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graciela S. Alarcon study chair
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by National Center for Research Resources (NCRR) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.