National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

Recruiting

• Conditions: SLE (Systemic Lupus)

• Registration Number: NCT04604990
• Lead Sponsor: King Saud University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-25
• Study First Posted: 2020-10-27
• Study Start: 2020-12-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2050-11-01
• Study Completion: 2050-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Accrual damage among SLE patients in Saudi Arabia	over 10 years	Mortality

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome	over 5 years	Medication adherence by using Modified Medication Adherence Response Scale (Modified MARS), an overall score of 4 and above is considered adherent.
Fetal and maternal outcomes in patients with SLE	over 5 years	Intrauterine fetal death, Abortion, Still birth, Eclampsia and pre-eclampsia, disease Activity

Trial Locations

Locations (1)

king Saud University medical city; 🇸🇦 Riyadh, Central Province, Saudi Arabia