National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04604990

Enrollment

1000

Registered

2020-10-27

Start date

2020-12-20

Completion date

2050-11-01

Last updated

2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SLE (Systemic Lupus)

Keywords

SLE, Lupus erythematosus, Outcomes, Phenotypes, Observational

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Disease Accrual damage among SLE patients in Saudi Arabia	over 10 years	SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000 (0-150) higher score representing higher disease activity

Secondary

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

Countries

Saudi Arabia

Contacts

Primary ContactIbrahim Almaghlouth, MSc(c), AmBIM, FRCPC, FACR

ialmaghlouth@ksu.edu.sa966544282266

Outcome results