SLE (Systemic Lupus)NCT04604990
National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia
An observational study of SLE (Systemic Lupus), run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- SLE (Systemic Lupus)
- How many people
- 1,000 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Dec 2020to 1 Nov 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who don't fulfil classification criteria mentioned above.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
king Saud University medical city
Riyadh, Central Province, 61961
Ibrahim Almaghlouth, 966118066932 ext. 0, ialmaghlouth@ksu.edu.sa
About this study
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
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over 10 years
Disease Accrual damage among SLE patients in Saudi Arabia
SLICC/ACR DI, Systemic Lupus International Collaboration Clinics/ American College of Rheumatology
Measured: over 10 years
Disease Accrual damage among SLE patients in Saudi Arabia
Mortality
Measured: over 10 years
Secondary outcomes (3)
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
Measured: over 5 years
Patient reported outcome
Medication adherence by using Modified Medication Adherence Response Scale (Modified MARS), an overall score of 4 and above is considered adherent.
Measured: over 5 years
Fetal and maternal outcomes in patients with SLE
Intrauterine fetal death, Abortion, Still birth, Eclampsia and pre-eclampsia, disease Activity
Measured: over 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start20 Dec 2020
- Primary completion1 Nov 2050 (estimated)
- Study completion1 Nov 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SLE (Systemic Lupus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Almaghlouth, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604990
- Sponsor's protocol ID
- E-19-3955/8
- Status last verified
- Aug 2021
- First submitted
- 12 Oct 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34397699
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia
- ClinicalTrials.gov ID
- NCT04604990
- Acronym / sponsor ID
- E-19-3955/8
- Conditions
- SLE (Systemic Lupus)
- Keywords
- SLE, Lupus erythematosus, Outcomes, Phenotypes, Observational
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 1 Nov 2050 (estimated)
- Study completion
- 1 Nov 2050 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who don't fulfil classification criteria mentioned above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Disease Accrual damage among SLE patients in Saudi Arabia
Time frame: over 10 years
Mortality
3 secondary outcomes
Patient reported outcome
Time frame: over 5 years
Patient reported outcome
Time frame: over 5 years
Fetal and maternal outcomes in patients with SLE
Time frame: over 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 34397699Almaghlouth 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE (Systemic Lupus), run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Almaghlouth, MSc(c), AmBIM, FRCPC, FACR (966544282266, ialmaghlouth@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Accrual damage among SLE patients in Saudi Arabia (time frame: over 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04604990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.