National systemic lupus erythematosus prospective cohort in Saudi Arabia: A study protocol.
Ibrahim A Almaghlouth, Lena M Hassen, Hana S Alahmari...
https://pubmed.ncbi.nlm.nih.gov/34397699Actively Recruiting
Age: 19Years +
All Genders
ID04604990
National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia
Led by King Saud University · Updated on 2021-09-01
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective cohort study in Saudi Arabia to better understand Systemic Lupus Erythematosus (SLE) in a population with high rates of consanguinity and inbreeding. This study aims to overcome limitations of previous retrospective studies by collecting detailed immunological, molecular, genetic, and microbiome data to clarify disease presentation, progression, and outcomes in SLE patients. The study follows an open cohort design without specific treatment interventions, focusing on observing patients over time. It will monitor disease accrual damage and collect patient-reported outcomes, fetal and maternal outcomes, providing comprehensive data on SLE progression and effects over several years. Participants will be adults diagnosed with SLE according to established classification criteria. Researchers will assess disease damage over 10 years and patient-reported outcomes over 5 years. The study involves long-term monitoring to track disease progression and impact, helping to improve understanding of SLE in this unique population.
CONDITIONS
Brief Title
National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients aged greater than 18 years old
- Patients must meet one of the following classification criteria for SLE: ACR, SLICC, or ACR/EULAR
- No restriction on time since SLE diagnosis
You will not qualify if you...
- Patients who do not meet any of the specified SLE classification criteria (ACR, SLICC, or ACR/EULAR)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 10 years
Participants are observed over time to assess disease progression and patient-reported outcomes.
Regular visits scheduled over 10 years
Trial Site Locations
Total: 1 location
1
king Saud University medical city
Riyadh, Central Province, Saudi Arabia, 61961
Actively Recruiting
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Research Team
I
Ibrahim Almaghlouth, MSc(c), AmBIM, FRCPC, FACR
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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