National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

SLE (Systemic Lupus) Clinical Trial

Official title:

National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04604990
• Other study ID #: E-19-3955/8
• Status: Recruiting
• Start date: December 20, 2020
• Est. completion date: November 1, 2050

Study information

• Verified date: August 2021
• Source: King Saud University
• Contact: Ibrahim Almaghlouth, MSc(c), AmBIM, FRCPC, FACR
• Phone: 966544282266
• Email: ialmaghlouth[@]ksu.edu.sa
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 1, 2050
• Est. primary completion date: November 1, 2050
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• SLE (Systemic Lupus)

Locations

Country	Name	City	State
Saudi Arabia	king Saud University medical city	Riyadh	Central Province

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	over 10 years
Primary	Disease Accrual damage among SLE patients in Saudi Arabia	SLICC/ACR DI, Systemic Lupus International Collaboration Clinics/ American College of Rheumatology	over 10 years
Primary	Disease Accrual damage among SLE patients in Saudi Arabia	Mortality	over 10 years
Secondary	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	over 5 years
Secondary	Patient reported outcome	Medication adherence by using Modified Medication Adherence Response Scale (Modified MARS), an overall score of 4 and above is considered adherent.	over 5 years
Secondary	Fetal and maternal outcomes in patients with SLE	Intrauterine fetal death, Abortion, Still birth, Eclampsia and pre-eclampsia, disease Activity	over 5 years