Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibrahim Almaghlouth, MSc(c), AmBIM, FRCPC, FACR | Contact | 966544282266 | ialmaghlouth@ksu.edu.sa |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| king Saud University medical city | Recruiting | Riyadh | Central Province | 61961 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34397699 | Derived | 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. |
Not provided
Not provided
Not provided
upon recruitment, informed consent form will be shared and before enrolment.
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2020 | Oct 25, 2020 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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 |