Vasculitis LupusNCT04386889
SLE Vasculitis In Egyptian Patients
A study testing Vasculitis In SLE in people with Vasculitis Lupus, run by Tabarak New Cairo Hospital (TNCH) at 1 site in Egypt.
Trial summary
Systemic lupus erythematosus (SLE) is a complex heterogeneous autoimmune disease with a wide variety of clinical and serological manifestations that may affect any organ. Vasculitis prevalence in SLE is reported to be between 11% and 36%. Read more about this study
- Who is it for?
- Ages 22 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasculitis Lupus
- What is being tested?
- Vasculitis In SLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2021to 25 Aug 2021
- Phase
- Interventional
- 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 22 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- LE or suspected SLE established by ACR criteria
- Ability to give informed consent
- Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)
- Ability of the patient or minor relative s parents to give informed consent
- Affected individuals age greater than or equal to 9 years with no upper age limit
- Healthy Volunteers (non-related) age greater than or equal to 18 with no upper age limit
- Healthy Volunteers (first- and second-degree relatives) age greater than or equal to 9 with no upper age limit
- Vascular studies adults only age greater than or equal to 18 with no upper age limit
Who cannot join
- Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of some lupus studies.
- Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH.
- Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations)
- Any comorbidity of medical or psychological/psychiatric condition or treatment after reviewing of patients previous or outside medical records, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient requiring urgent and/or acute medical care, surgical or other procedures)
- Unwilling to participate in research studies or to provide research samples or data.
- Criteria for exclusion:
Show all 21Show fewer
- Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for
- EXCLUSION CRITERIA FOR VASCULAR STUDIES ONLY, FOR SLE AND HEALTHY CONTROLS:
- Subjects with a contraindication to MRI scanning will not receive the optional Cardiovascular MRI. These contraindications include subjects with the following devices:
- Central nervous system aneurysm clips unless it is labeled safe or conditional for MRI
- Implanted neural stimulator (e.g.TENS-Unit) unless it is labeled safe or conditional for MRI
- Implanted cardiac pacemaker or defibrillator
- Cochlearor any type of ear implant unless it is labeled safe or conditional for MRI
- Ocular foreign body (e.g. metal shavings)
- Implanted Insulin pump or drug infusion device unless it is labeled safe or conditional for MRI
- Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI
- Subjects with renal excretory dysfunction, estimated glomerular filtration rate < 60 mL/min/1.73m(2) using the CKD-EPI equation or equivalent (using the CRIS-calculated eGFR to define the threshold) and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but will not be exposed to the cardiac CT angiography, or gadolinium-based contrast agents.
- Any clinical instability precluding subject from getting MRI as determined by the enrolling clinician.
- Pregnant or lactating women will be excluded from vascular studies.
- Healthy controls with known history of coronary artery disease, peripheral vascular disease or atherosclerosis.
- Individuals younger than 18 years old will be excluded given the radiation exposure as well as the lack of proper validation for the proposed vascular function studies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tabarak New Cairo Hospital
Cairo, 11613
Tayseer A Abdulaal, M.D., +201223407675, tayseer@mail.com
About this study
Official title: SLE Vasculitis Incidence In Female Egyptian Patients
Systemic lupus erythematosus (SLE) is a complex heterogeneous autoimmune disease with a wide variety of clinical and serological manifestations that may affect any organ. Vasculitis prevalence in SLE is reported to be between 11% and 36%.
Read the detailed description
Systemic lupus erythematosus (SLE) is a complex heterogeneous autoimmune disease with a wide variety of clinical and serological manifestations that may affect any organ. Vasculitis prevalence in SLE is reported to be between 11% and 36%. A diverse clinical spectrum, due to inflammatory involvement of vessels of all sizes, is present. Even though cutaneous lesions, representing small vessel involvement, are the most frequent, medium and large vessel vasculitis may present with visceral affection, with life-threatening manifestations such as mesenteric vasculitis, pulmonary hemorrhage, or mononeuritis multiplex, with detrimental consequences. Early recognition and an appropriate treatment are crucial. Recent studies have shown that vasculitis in patients with SLE may present different clinical forms based on the organ involved and the size of the affected vessel. It is noteworthy that the episodes of vasculitis are not always accompanied by high disease activity. Recent articles on this topic have focused on new treatments for the control of vascular disease, such as biological therapies such as Rituximab and Belimumab, among others.
- Conditions
- Vasculitis Lupus
- Being tested
- Vasculitis In SLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasculitis In SLEOther
20 SLE female Egyptian patients, among them we are going to study the vasculitic pattern incidence.
| Study group | Role | What they receive |
|---|---|---|
| SLE Vasculitis | Other | 20 SLE Female patients will subjected to study of the all vasculitic pattern that may occur. Receives: Other: Vasculitis In SLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE Vasculitis
Incidence of vasculitic pattern
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start25 Mar 2021 (estimated)
- Primary completion25 Jul 2021 (estimated)
- Study completion25 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasculitis LupusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabarak New Cairo Hospital (TNCH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. /Tayseer Abdulaal, Tabarak New Cairo Hospital (TNCH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386889
- Sponsor's protocol ID
- SLE Tabarak 01
- Status last verified
- Dec 2020
- First submitted
- 9 May 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLE Vasculitis Incidence In Female Egyptian Patients
- ClinicalTrials.gov ID
- NCT04386889
- Acronym / sponsor ID
- SLE Tabarak 01
- Conditions
- Vasculitis Lupus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tabarak New Cairo Hospital (TNCH)University, hospital or other
- Study start
- 25 Mar 2021 (estimated)
- Primary completion
- 25 Jul 2021 (estimated)
- Study completion
- 25 Aug 2021 (estimated)
- First posted
- 13 May 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.
Systemic lupus erythematosus (SLE) is a complex heterogeneous autoimmune disease with a wide variety of clinical and serological manifestations that may affect any organ. Vasculitis prevalence in SLE is reported to be between 11% and 36%.
Detailed description
Systemic lupus erythematosus (SLE) is a complex heterogeneous autoimmune disease with a wide variety of clinical and serological manifestations that may affect any organ. Vasculitis prevalence in SLE is reported to be between 11% and 36%. A diverse clinical spectrum, due to inflammatory involvement of vessels of all sizes, is present. Even though cutaneous lesions, representing small vessel involvement, are the most frequent, medium and large vessel vasculitis may present with visceral affection, with life-threatening manifestations such as mesenteric vasculitis, pulmonary hemorrhage, or mononeuritis multiplex, with detrimental consequences. Early recognition and an appropriate treatment are crucial. Recent studies have shown that vasculitis in patients with SLE may present different clinical forms based on the organ involved and the size of the affected vessel. It is noteworthy that the episodes of vasculitis are not always accompanied by high disease activity. Recent articles on this topic have focused on new treatments for the control of vascular disease, such as biological therapies such as Rituximab and Belimumab, among others.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLE Vasculitis | Other | Other: Vasculitis In SLE20 SLE Female patients will subjected to study of the all vasculitic pattern that may occur. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- LE or suspected SLE established by ACR criteria
- Ability to give informed consent
- Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)
- Ability of the patient or minor relative s parents to give informed consent
- Affected individuals age greater than or equal to 9 years with no upper age limit
Key exclusion criteria (21 listed)
- Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of some lupus studies.
- Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH.
- Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations)
- Any comorbidity of medical or psychological/psychiatric condition or treatment after reviewing of patients previous or outside medical records, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient requiring urgent and/or acute medical care, surgical or other procedures)
- Unwilling to participate in research studies or to provide research samples or data.
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 |
|---|---|---|
| Vasculitis In SLE20 SLE female Egyptian patients, among them we are going to study the vasculitic pattern incidence. | Other | SLE Vasculitis |
Primary outcome
SLE Vasculitis
Time frame: 6 months
Incidence of vasculitic pattern
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
Related trials for Vasculitis Lupus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Recruiting
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Systemic Lupus Erythematosus, Systemic Sclerosis
RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
RecruitingPhase 1
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasculitis In SLE in people with Vasculitis Lupus, run by Tabarak New Cairo Hospital (TNCH) at 1 site in Egypt.
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 8 inclusion and 21 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 14 Dec 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tayseer A Abdulaal, M.D. (+201223407675, tayseer@mail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLE Vasculitis (time frame: 6 months). 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 14 Dec 2020.