National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

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 Overview

• Status: Recruiting
• Conditions: SLE (Systemic Lupus)

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Ibrahim Almaghlouth, MSc(c), AmBIM, FRCPC, FACR; Phone Number: 966544282266; Email: ialmaghlouth@ksu.edu.sa

Study Locations

• Saudi Arabia
  • Central Province
    • Riyadh, Central Province, Saudi Arabia, 61961
      • Recruiting
      • King Saud University Medical City
      • Contact: Ibrahim Almaghlouth; Phone Number: 966118066932; Email: ialmaghlouth@ksu.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Disease Accrual damage among SLE patients in Saudi Arabia	SLICC/ACR DI, Systemic Lupus International Collaboration Clinics/ American College of Rheumatology	over 10 years
Disease Accrual damage among SLE patients in Saudi Arabia	Mortality	over 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Fetal and maternal outcomes in patients with SLE	Intrauterine fetal death, Abortion, Still birth, Eclampsia and pre-eclampsia, disease Activity	over 5 years

Collaborators and Investigators

• Sponsor: King Saud University

Publications and helpful links

General Publications

• Almaghlouth IA, Hassen LM, Alahmari HS, Bedaiwi A, Albarrak R, Daghestani M, Alqurtas E, Alkhalaf A, Bedaiwi M, Omair M, Almogairen S, Alarfaj H, Alarfaj A. National systemic lupus erythematosus prospective cohort in Saudi Arabia: A study protocol. Medicine (Baltimore). 2021 Jul 30;100(30):e26704. doi: 10.1097/MD.0000000000026704. Erratum In: Medicine (Baltimore). 2021 Aug 27;100(34):e27039.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2020
• Primary Completion (Anticipated): November 1, 2050
• Study Completion (Anticipated): November 1, 2050

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 25, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: SLE; Observational; Outcomes; Phenotypes; Lupus erythematosus
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: E-19-3955/8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: upon recruitment, informed consent form will be shared and before enrolment.
• IPD Sharing Supporting Information Type: Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No