Systemic Lupus ErythematosusNCT05045417
IL17 in Systemic Lupus Erythematosus Patients: Association With Disease Activity and Organ Damage
An observational study of Systemic Lupus Erythematosus, run by Sohag University at 1 site in Egypt.
Trial summary
Many laboratory markers can be measured for assessment of Lupus activity as aberrant manufacturing and imbalance of the cytokines of T-helper cell which already have been implicated within autoimmunity pathogenesis as IL-18 and IL-10 levels are usually elevated in lupus sufferers and correlated with SLEDAI score IL-17… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Serum level of IL-17
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 30 Apr 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * The study will include 110 patients with SLE : * 40 with lupus nephritis * 40 with interstitial lung disease * 30 SLE patients without internal organ affection) * In addition to 30 sex and age matched healthy individuals as a control group
Who may be able to join
- SLE will be diagnosed according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
- Age ≥ 18 years.
- Patients who are able and willing to give written informed consent
Who cannot join
- -Any other autoimmune disease rather than SLE. -
- Systemic diseases
- Malignancy
- pregnancy
Trial locations and contacts
1 site in 1 country.
Faten E Mohamed, professor contact
About this study
Many laboratory markers can be measured for assessment of Lupus activity as aberrant manufacturing and imbalance of the cytokines of T-helper cell which already have been implicated within autoimmunity pathogenesis as IL-18 and IL-10 levels are usually elevated in lupus sufferers and correlated with SLEDAI score IL-17 has been linked to immune-mediated organ damage in several autoimmune diseases and recently it has been linked to pathogenesis of a murine model of lupus and human lupus Diverse cytokine abnormalities which common in lupus patients may skew T cells differentiation into IL-17-producing CD4+ and double negative T cells. This could promote the autoimmune process by activation of immune cells \&stimulation of proliferation of B-cell and production of antibody
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Serum level of IL-17
- 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.
Serum level of IL-17Diagnostic test
Measurement of serum level of IL-17 :
- To explore the role of IL-17 in systemic lupus erythematosus
- To determine the relation between IL-17 and lupus disease activity
- To analyze the correlation between IL-17 and internal organ affection (lupus nephritis , interstitial lung disease)
| Study group | Role | What they receive |
|---|---|---|
| Cases with SLE | 110 patients with SLE will be divided to :
* 40 patients with lupus nephritis
* 40 patients interstitial lung disease
* 30 SLE patients without internal organ affection) Receives: Diagnostic Test: Serum level of IL-17 | |
| control group | 30 sex and age matched healthy individuals as a control group Receives: Diagnostic Test: Serum level of IL-17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE disease activity index (SLEDAI)
- Assessment of the disease activity in the patients will be done by using the SLE disease activity index (SLEDAI). It potentially measures reversible manifestations of the underlying inflammatory disease process. The scale includes24 "weighted" attribute grouped into 9 domains. The final score is the sum of all attributed scores.
- No activity 0
- mild activity: 1-5
- moderate activity: 6- 1 0
- high activity : 1 1 - 1 9
- very high > 20
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Sohag 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-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Ali, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045417
- Sponsor's protocol ID
- Soh-Med-21-09-22
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Crispin JC, Tsokos GC. IL-17 in systemic lupus erythematosus. J Biomed Biotechnol. 2010;2010:943254. doi: 10.1155/2010/943254. Epub 2010 Apr 6.
PubMed 20379379Garrett-Sinha LA, John S, Gaffen SL. IL-17 and the Th17 lineage in systemic lupus erythematosus. Curr Opin Rheumatol. 2008 Sep;20(5):519-25. doi: 10.1097/BOR.0b013e328304b6b5.
PubMed 18698171Su DL, Lu ZM, Shen MN, Li X, Sun LY. Roles of pro- and anti-inflammatory cytokines in the pathogenesis of SLE. J Biomed Biotechnol. 2012;2012:347141. doi: 10.1155/2012/347141. Epub 2012 Feb 15.
PubMed 22500087
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL17 in Systemic Lupus Erythematosus Patients: Association With Disease Activity and Organ Damage
- ClinicalTrials.gov ID
- NCT05045417
- Acronym / sponsor ID
- Soh-Med-21-09-22
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 16 Sep 2021 (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.
Many laboratory markers can be measured for assessment of Lupus activity as aberrant manufacturing and imbalance of the cytokines of T-helper cell which already have been implicated within autoimmunity pathogenesis as IL-18 and IL-10 levels are usually elevated in lupus sufferers and correlated with SLEDAI score IL-17 has been linked to immune-mediated organ damage in several autoimmune diseases and recently it has been linked to pathogenesis of a murine model of lupus and human lupus Diverse cytokine abnormalities which common in lupus patients may skew T cells differentiation into IL-17-producing CD4+ and double negative T cells. This could promote the autoimmune process by activation of immune cells \&stimulation of proliferation of B-cell and production of antibody
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with SLE | – | Diagnostic Test: Serum level of IL-17110 patients with SLE will be divided to : * 40 patients with lupus nephritis * 40 patients interstitial lung disease * 30 SLE patients without internal organ affection) |
| control group | – | Diagnostic Test: Serum level of IL-1730 sex and age matched healthy individuals as a control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * The study will include 110 patients with SLE : * 40 with lupus nephritis * 40 with interstitial lung disease * 30 SLE patients without internal organ affection) * In addition to 30 sex and age matched healthy individuals as a control group
Key inclusion criteria (3 listed)
- SLE will be diagnosed according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
- Age ≥ 18 years.
- Patients who are able and willing to give written informed consent
Key exclusion criteria (4 listed)
- -Any other autoimmune disease rather than SLE. -
- Systemic diseases
- Malignancy
- 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 |
|---|---|---|
| Serum level of IL-17Measurement of serum level of IL-17 : 1. To explore the role of IL-17 in systemic lupus erythematosus 2. To determine the relation between IL-17 and lupus disease activity 3. To analyze the correlation between IL-17 and internal organ affection (lupus nephritis , interstitial lung disease) | Diagnostic test | Cases with SLE, control group |
Primary outcome
SLE disease activity index (SLEDAI)
Time frame: 18 Months
• Assessment of the disease activity in the patients will be done by using the SLE disease activity index (SLEDAI). It potentially measures reversible manifestations of the underlying inflammatory disease process. The scale includes24 "weighted" attribute grouped into 9 domains. The final score is the sum of all attributed scores. * No activity 0 * mild activity: 1-5 * moderate activity: 6- 1 0 * high activity : 1 1 - 1 9 * very high > 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 20379379Crispin JC, Tsokos GC. IL-17 in systemic lupus erythematosus. J Biomed Biotechnol. 2010;2010:943254. doi: 10.1155/2010/943254. Epub 2010 Apr 6.
- Background: PubMed 18698171Garrett-Sinha LA, John S, Gaffen SL. IL-17 and the Th17 lineage in systemic lupus erythematosus. Curr Opin Rheumatol. 2008 Sep;20(5):519-25. doi: 10.1097/BOR.0b013e328304b6b5.
- Background: PubMed 22500087Su DL, Lu ZM, Shen MN, Li X, Sun LY. Roles of pro- and anti-inflammatory cytokines in the pathogenesis of SLE. J Biomed Biotechnol. 2012;2012:347141. doi: 10.1155/2012/347141. Epub 2012 Feb 15.
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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.
Faten E Mohamed, professor contact
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 Systemic Lupus Erythematosus, run by Sohag University 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 3 inclusion and 4 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 16 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 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 Aya M Ahmed, assistant lecturer (01013325505, aya.ali1@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLE disease activity index (SLEDAI) (time frame: 18 Months). 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 NCT05045417, which also lists 3 linked publications.
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 16 Sep 2021.