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NCT Number: NCT04604990

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.

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Key information

Conditions

SLE (Systemic Lupus) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

king Saud University medical city

Riyadh, Central Province, 61961, Saudi Arabia

Location status: Recruiting

Location contact

Ibrahim Almaghlouth

CONTACT

[email protected]

966118066932

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Disease Accrual damage among SLE patients in Saudi Arabia

    Time frame: over 10 years

    SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000 (0-150) higher score representing higher disease activity

  2. Disease Accrual damage among SLE patients in Saudi Arabia

    Time frame: over 10 years

    SLICC/ACR DI, Systemic Lupus International Collaboration Clinics/ American College of Rheumatology

  3. Disease Accrual damage among SLE patients in Saudi Arabia

    Time frame: over 10 years

    Mortality

Secondary outcomes

  1. Patient reported outcome

    Time frame: 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

  2. Patient reported outcome

    Time frame: over 5 years

    Medication adherence by using Modified Medication Adherence Response Scale (Modified MARS), an overall score of 4 and above is considered adherent.

  3. Fetal and maternal outcomes in patients with SLE

    Time frame: over 5 years

    Intrauterine fetal death, Abortion, Still birth, Eclampsia and pre-eclampsia, disease Activity

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

966544282266

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Important dates

Study start
2020
Primary completion
2050
Study completion
2050
First posted
Oct 27, 2020
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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