An observational study in SLE (Systemic Lupus), sponsored by King Saud University. Recruiting at 1 site in Saudi Arabia. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by King Saud University · Observational
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →King Saud University is the lead sponsor of 164 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from KSU-SLE specialized clinic. The clinic receive general referral from general rheumatology clinics in KSU and general referral from other clinics inside or outside KSU. The estimated number is 1000 patients.
Exclusion Criteria:
Disease Accrual damage among SLE patients in Saudi Arabia
SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000 (0-150) higher score representing higher disease activity
Time frame: over 10 years
Disease Accrual damage among SLE patients in Saudi Arabia
SLICC/ACR DI, Systemic Lupus International Collaboration Clinics/ American College of Rheumatology
Time frame: over 10 years
Disease Accrual damage among SLE patients in Saudi Arabia
Mortality
Time frame: over 10 years
Patient reported outcome
PROMIS ( Patient Reported Outcome Measurement Information Scale) there are several data collection tool for calculating score (will use REDCap auto score). Each question usually has 5 response option ranging in value from one to five. For example, the adult 8-item, the lowest possible score is 8, the highest possible score is 40
Time frame: over 5 years
Patient reported outcome
Medication adherence by using Modified Medication Adherence Response Scale (Modified MARS), an overall score of 4 and above is considered adherent.
Time frame: over 5 years
Fetal and maternal outcomes in patients with SLE
Intrauterine fetal death, Abortion, Still birth, Eclampsia and pre-eclampsia, disease Activity
Time frame: over 5 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
Supporting information: Icf
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lupus Erythematosus, Systemic→
King Saud University