National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

King Saud University1,000 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

SLE (Systemic Lupus)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult patients defined as age greater than 18 years old. 2. Patients should fulfil one of the following classification criteria for SLE (ACR, SLICC or ACR/EULAR criteria). 3. No restriction on time of diagnosis. Exclusion Criteria: * Patients who don't fulfil classification criteria mentioned above.

Locations (1)

king Saud University medical city

Riyadh, Central Province, Saudi Arabia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts