National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: SLE (Systemic Lupus). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
SLE disease in Saudi Arabia is yet not well defined especially in a population with high consanguinity and high inbreeding coefficient . Up until now, there has been no prospective cohort study for SLE patients in Saudi Arabia. As a result, current published literature is focused on retrospective chart reviews which are subjected to many forms of bias. so the investigator proposed this prospective registry which will follow open cohort study design aiming to provide better understanding of disease presentation, course and outcomes especially if complemented by detailed immunological, molecular, genetic and microbiome data.
Primary outcome measures
- Disease Accrual damage among SLE patients in Saudi Arabia [Time frame: over 10 years]
- Disease Accrual damage among SLE patients in Saudi Arabia [Time frame: over 10 years]
- Disease Accrual damage among SLE patients in Saudi Arabia [Time frame: over 10 years]
Secondary outcome measures (3)
- Patient reported outcome [Time frame: over 5 years]
- Patient reported outcome [Time frame: over 5 years]
- Fetal and maternal outcomes in patients with SLE [Time frame: over 5 years]
Eligibility criteria
Inclusion criteria
- Adult patients defined as age greater than 18 years old.
- Patients should fulfil one of the following classification criteria for SLE (ACR, SLICC or ACR/EULAR criteria).
- No restriction on time of diagnosis.
Exclusion criteria
- Patients who don't fulfil classification criteria mentioned above.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Saudi Arabia · 1 center
- king Saud University medical city — Riyadh
Publications
- Almaghlouth IA, Hassen LM, Alahmari HS, Bedaiwi A, Albarrak R, Daghestani M, Alqurtas E, Alkhalaf A, Bedaiwi M, Omair M, Almogairen S, Alarfaj H, Alarfaj A. National systemic lupus erythematosus prospective cohort in Saudi Arabia: A study protocol. Medicine (Baltimore). 2021 Jul 30;100(30):e26704. doi: 10.1097/MD.0000000000026704. PMID 34397699
Identifiers
NCT: NCT04604990 · E-19-3955/8