Search / Trial NCT00001372

Study of Systemic Lupus Erythematosus

Launched by NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) · Nov 3, 1999

Trial Information

Current as of November 14, 2024

Recruiting

Keywords

Longitudinal Study Natural History Lupus Nephritis Lupus Systemic Lupus Sle

ClinConnect Summary

This clinical trial is studying systemic lupus erythematosus (SLE), an autoimmune disease where the body's immune system mistakenly attacks its own tissues. The researchers want to understand how SLE develops and changes over time, as well as identify genetic factors that may make some people more likely to develop the disease. If you or a family member is at least 3 years old and has been diagnosed with SLE or has symptoms suggesting SLE, you might be eligible to participate. Relatives of patients may also take part by providing a DNA sample to help with genetic studies.

Participants in the study can expect to undergo various assessments, including medical history reviews, physical exams, and tests like blood and urine analysis. Some may have additional tests such as imaging scans or biopsies to gather more information about the disease. Participants will be followed regularly, with at least one check-up a year, and their doctors will receive treatment recommendations based on the findings. This study is currently recruiting participants, and it aims to deepen our understanding of SLE to improve care for those affected.

Gender

ALL

Eligibility criteria

  • * INCLUSION CRITERIA:
  • SLE or suspected SLE established by ACR/EULAR or ACR criteria
  • Ability to give informed consent
  • Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)
  • Ability of the patient or minor relative s parents to give informed consent
  • Affected individuals age \>= 3 years with no upper age limit
  • Healthy Volunteers (non-related) age \>=18 with no upper age limit
  • Healthy Volunteers (first- and second-degree relatives) age \>=3 with no upper age limit
  • Vascular studies adults only age \>=18 with no upper age limit
  • EXCLUSION CRITERIA:
  • Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of some lupus studies.
  • Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH.
  • Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations)
  • Any comorbidity of medical or psychological/psychiatric condition or treatment after reviewing of patients previous or outside medical records, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient
  • requiring urgent and/or acute medical care, surgical or other procedures)
  • -Unwilling to participate in research studies or to provide research samples or data
  • Criteria for Exclusion:
  • Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for
  • EXCLUSION CRITERIA FOR VASCULAR STUDIES ONLY, FOR SLE AND HEALTHY CONTROLS:
  • * Subjects with a contraindication to MRI scanning will not receive the optional Cardiovascular MRI. These contraindications include subjects with the following devices:
  • Central nervous system aneurysm clips unless it is labeled safe or conditional for MRI
  • Implanted neural stimulator (e.g.TENS-Unit) unless it is labeled safe or conditional for MRI
  • Implanted cardiac pacemaker or defibrillator unless it is labeled safe or conditional for MRI
  • Cochlear or any type of ear implant unless it is labeled safe or conditional for MRI
  • Ocular foreign body (e.g. metal shavings)
  • Implanted Insulin pump or drug infusion device unless it is labeled safe or conditional for MRI
  • Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI
  • Subjects with renal excretory dysfunction, estimated glomerular filtration rate \< 60 mL/min/1.73m(2) using the CKD-EPI equation or equivalent (using the CRIS-calculated eGFR to define the threshold) and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but will not be exposed to the cardiac CT angiography, or gadolinium-based contrast agents.
  • Pregnant or lactating women will be excluded from vascular studies.
  • Any clinical instability precluding subject from getting MRI as determined by the enrolling clinician.
  • Healthy controls with known history of coronary artery disease, peripheral vascular disease or atherosclerosis.
  • Individuals younger than 18 years old will be excluded given the radiation exposure as well as the lack of proper validation for the proposed vascular function studies.

Trial Officials

Sarfaraz A Hasni, M.D.

Principal Investigator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

About National Institute Of Arthritis And Musculoskeletal And Skin Diseases (Niams)

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is a pivotal component of the National Institutes of Health (NIH) dedicated to advancing research and knowledge in the fields of arthritis, musculoskeletal disorders, and skin diseases. NIAMS sponsors a wide range of clinical trials aimed at improving the diagnosis, treatment, and prevention of these conditions. By fostering innovative research, collaborating with healthcare professionals, and engaging with patient communities, NIAMS strives to enhance the quality of life for individuals affected by these diseases, while promoting scientific discovery and public health initiatives.

Locations

Bethesda, Maryland, United States

Lahore Pb, , Pakistan

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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