National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

NCT ID: NCT04604990

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-20

Study Completion Date

2050-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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SLE (Systemic Lupus)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Saud University

OTHER

Sponsor Role lead

Responsible Party

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Ibrahim Almaghlouth

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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king Saud University medical city

Riyadh, Central Province, Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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

Role: CONTACT

966544282266

Facility Contacts

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Ibrahim Almaghlouth

Role: primary

966118066932 ext. 0

References

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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.

Reference Type DERIVED
PMID: 34397699 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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E-19-3955/8

Identifier Type: -

Identifier Source: org_study_id

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