Systemic Lupus ErythematosusNCT03178721
Regulatory BCells in Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
Trial summary
Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many diagnostic and management challenges. One such challenge is the excess cardiovascular disease observed in patients with Systemic lupus erythematosus . Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- blood sample
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2017to 25 Jul 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: adult patients with systemic lupus erythematosus
Who may be able to join
- Clinical and laboratory Diagnosis of Systemic Lupus disease.
- Must be adult.
Who cannot join
- Patients with clinical atherosclerotic vascular disease
- pregnancy.
About this study
Official title: Regulatory BCells in Systemic Lupus Erythematosus and Its Relation to Atherosclerosis and Disease Activity
Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many diagnostic and management challenges. One such challenge is the excess cardiovascular disease observed in patients with Systemic lupus erythematosus . Coronary heart disease and other manifestations of atherosclerosis continue to be a major cause of death in patients with Systemic lupus erythematosus.Regulatory B-cells have been identified as a negative regulator of the immune system that inhibit pathological immune response by suppressing both uncontrolled protective immune response and damaging autoimmune responses
Read the detailed description
Regulatory B cells have been identified as an IL10 producing B cells subsets that are characterized by the expression of CD19 CD24hiCD38hi . Breg cells can inhibit inflammatory responses in autoimmune disease, like Systemic lupus erythematosus, via the production of IL-10 (an antiatherogenic cytokine) which will suppress TNF- α production by monocytes leading to inhibition of T cell-mediated inflammation. Regulatory B have a vital role in immune tolerance and their deficiency resulted in exacerbation of autoimmunity . Evidence suggests Breg in autoimmune disease may be dysfunctional .
In this proposal, We suggest IL-10 production by Breg confers an atheroprotective role. In Systemic lupus erythematosus, Regulatory B ability to control atherosclerosis is reduced therefore, we will test the hypothesis that Regulatory B play an important role in both autoimmunity and accelerated atherosclerosis and dysfunction in Regulatory B from autoimmune disease may or may not result in a reduced ability to control atherosclerosis .
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- blood sample
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleDiagnostic test
Also called Coronary calcium scoring: all participants will be scanned using a 64-slice CT scanner and Carotid intimae media thickness (CIMT): Carotid artery ultrasonography
study B regulatory in blood and its correlation with atherosclerosis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Systemic lupus erythematosus with atherosclerosis Receives: Diagnostic Test: blood sample | |
| 2 | Systemic lupus erythematosus without atherosclerosis Receives: Diagnostic Test: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary calcium scoring
using Agatston score none (Agatston 0 U) mild (Agatston 1-99 U) moderate(Agatston 100-399 U) high(Agatston >400 U)
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start25 Jun 2017 (estimated)
- Primary completion25 Jun 2018 (estimated)
- Study completion25 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed Shawky, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178721
- Sponsor's protocol ID
- breg
- Status last verified
- May 2017
- First submitted
- 30 May 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory BCells in Systemic Lupus Erythematosus and Its Relation to Atherosclerosis and Disease Activity
- ClinicalTrials.gov ID
- NCT03178721
- Acronym / sponsor ID
- breg
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Jun 2017 (estimated)
- Primary completion
- 25 Jun 2018 (estimated)
- Study completion
- 25 Jul 2018 (estimated)
- First posted
- 7 Jun 2017 (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.
Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many diagnostic and management challenges. One such challenge is the excess cardiovascular disease observed in patients with Systemic lupus erythematosus . Coronary heart disease and other manifestations of atherosclerosis continue to be a major cause of death in patients with Systemic lupus erythematosus.Regulatory B-cells have been identified as a negative regulator of the immune system that inhibit pathological immune response by suppressing both uncontrolled protective immune response and damaging autoimmune responses
Detailed description
Regulatory B cells have been identified as an IL10 producing B cells subsets that are characterized by the expression of CD19 CD24hiCD38hi . Breg cells can inhibit inflammatory responses in autoimmune disease, like Systemic lupus erythematosus, via the production of IL-10 (an antiatherogenic cytokine) which will suppress TNF- α production by monocytes leading to inhibition of T cell-mediated inflammation. Regulatory B have a vital role in immune tolerance and their deficiency resulted in exacerbation of autoimmunity . Evidence suggests Breg in autoimmune disease may be dysfunctional .
In this proposal, We suggest IL-10 production by Breg confers an atheroprotective role. In Systemic lupus erythematosus, Regulatory B ability to control atherosclerosis is reduced therefore, we will test the hypothesis that Regulatory B play an important role in both autoimmunity and accelerated atherosclerosis and dysfunction in Regulatory B from autoimmune disease may or may not result in a reduced ability to control atherosclerosis .
Study design
- Observational model
- Case crossover
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: blood sampleSystemic lupus erythematosus with atherosclerosis |
| 2 | – | Diagnostic Test: blood sampleSystemic lupus erythematosus without atherosclerosis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- adult patients with systemic lupus erythematosus
Key inclusion criteria (2 listed)
- Clinical and laboratory Diagnosis of Systemic Lupus disease.
- Must be adult.
Key exclusion criteria (2 listed)
- Patients with clinical atherosclerotic vascular disease
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleAlso: Coronary calcium scoring: all participants will be scanned using a 64-slice CT scanner and Carotid intimae media thickness (CIMT): Carotid artery ultrasonographystudy B regulatory in blood and its correlation with atherosclerosis | Diagnostic test | 1, 2 |
Primary outcome
Coronary calcium scoring
Time frame: 1year
using Agatston score none (Agatston 0 U) mild (Agatston 1-99 U) moderate(Agatston 100-399 U) high(Agatston >400 U)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary calcium scoring (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2017.