National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

NCT04604990 | Recruiting

• 1 other identifier: E-19-3955/8
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

SLE (Systemic Lupus)

Keywords

SLE; Lupus erythematosus; Outcomes; Phenotypes; Observational

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Patient reported outcome

  over 5 years

• Patient reported outcome

  over 5 years

• Fetal and maternal outcomes in patients with SLE

  over 5 years

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who don't fulfil classification criteria mentioned above.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

king Saud University medical city

Riyadh, Central Province, 61961, Saudi Arabia

RECRUITING

Related Publications (1)

• 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. doi: 10.1097/MD.0000000000027039.

  PMID: 34397699 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Each patient will have two comprehensive visit during which 4 heparin blood tubes will be collected from the patient for biobanking storage (exception will be for pregnant patients who will have biological sample collection at the beginning of each trimester along with postpartum sample (six weeks from delivery). Once the blood is withdrawn, it will be sorted into: plasma separation, (immune cell sorting using flow cytometry to into major cell line including T-cells, B cells, mononuclear cells and granulocytes/versus storage as PBMC - the decision will be guided by available fund), RNA and DNA then stored at appropriate temperature using patient unique research identification number. For DNA processing; blood will be collected using standardized phlebotomy technique directly into PAXgene Blood DNA tubes.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Ibrahim Almaghlouth, MSc(c), AmBIM, FRCPC, FACR

CONTACT

966544282266; ialmaghlouth@ksu.edu.sa

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 27, 2020
• Study Start: December 20, 2020
• Primary Completion (Estimated): November 1, 2050
• Study Completion (Estimated): November 1, 2050
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: upon recruitment, informed consent form will be shared and before enrolment.

Locations

SA (1)