National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia
ConditionSLE (Systemic Lupus)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorKing Saud University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who don't fulfil classification criteria mentioned above.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 years2
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 years3
Disease Accrual damage among SLE patients in Saudi Arabia
Mortality
Time frame
over 10 yearsSecondary outcomes
1
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 years2
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 years3
Fetal and maternal outcomes in patients with SLE
Intrauterine fetal death, Abortion, Still birth, Eclampsia and pre-eclampsia, disease Activity
Time frame
over 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov