SLENCT05161988
Serum IL 26 as a Marker of Disease Activity in SLE
An observational study of SLE, run by Assiut University.
Trial summary
Assessment of serum Interleukin 26 level in SLE patients and compare it with healthy controls. Association of serum interleukin 26 with SLE activity and severity. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- SLE
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2021to 1 May 2025
- 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 15 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Any patients fulfillef the critria o 2012 SLE international collaborating clinics and admition to Assiut University are participate in this study .
Who may be able to join
- Adult SLE Patients who fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria
Who cannot join
- Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
Trial locations and contacts
No sites are listed yet.
About this study
Assessment of serum Interleukin 26 level in SLE patients and compare it with healthy controls.
Association of serum interleukin 26 with SLE activity and severity.
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic inflammatory disease characterized by diverse autoantibodies and varied clinical manifestations(mainly targeting the skin, kidneys, and brain). Autoantibodies directed against double-stranded (ds) DNA play a key role in the initiation and maintenance of inflammatory lesions in SLE(1).
Pathogenesis of SLE is mirrored by its complex aetiopathogenesis as genetic factors , environmental triggers (exposure to sunlight, drugs and infections, particularly with Epstein-Barr virus. . Causing secretion of inflammatory mediators , antibody and cytokines . But still pathological mechanisms of SLE are still not fully understood. (2) Immune system dysregulation such as incomplete clearance of apoptotic materials, hyperactivation of immune cells, overproduction of antibodies and abundant immune complex deposits are prominent in SLE (3) Clinical manifestations of SLE are Malar rash, Discoid rash ,Photosensitivity, Oral or nasopharyngeal ulcers, Pleurisy, Renal abnormalities, Immunologic abnormalities, Nonscarring alopecia, Synovitis, Hemolytic anemia, Leukopenia, Thrombocytopenia Proteinuria Seizures Psychosis Serositis and Arthritis (4) IL-26 is a 171-amino acid protein that belongs to the IL-10 family of cytokines, a family that includes IL-10, IL-19, IL-20, IL-22 and IL-24 . The IL-26 protein is encoded by the IL26 gene located on chromosome 12q15 between genes for interferon (IFN)-γ and IL-22 , and is conserved in several vertebrate species but not in mice and rats . The cytokine IL-26 was originally named AK155(5) IL-26 was initially identified as a pro-inflammatory cytokine , inducing the production of inflammatory cytokines by myeloid cells that are involved in the differentiation of naïve CD4+ T cells into Th17 cells (6) The involvement of IL 26 in numerous chronic auto inflammatory diseases and in two major pathogenic processes in SLE, namely the induction of IFN I and its production by Th 17 lymphocytes, makes the analysis of its role in SLE essential (7) Brilland et al., 2021 report that the levels of IL 26 are higher in SLE patients than healthy subjects and show a significant correlation with disease activity
- Conditions
- SLE
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of serum interleukin-26 level .
Assessment of serum interleukin-26 level in SLE patients and compare it with the serum interleukin-26 level in healthy
Measured: baseline
Secondary outcomes (1)
Association !!
Association of serum interleukin 26 with SLE activity and severity.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start10 Dec 2021 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SLEStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma alzahraa Mustafa Abdelbary Thabet, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161988
- Sponsor's protocol ID
- SLE IL26
- Status last verified
- Dec 2021
- First submitted
- 4 Dec 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Knappe A, Hor S, Wittmann S, Fickenscher H. Induction of a novel cellular homolog of interleukin-10, AK155, by transformation of T lymphocytes with herpesvirus saimiri. J Virol. 2000 Apr;74(8):3881-7. doi: 10.1128/jvi.74.8.3881-3887.2000.
PubMed 10729163Maidhof W, Hilas O. Lupus: an overview of the disease and management options. P T. 2012 Apr;37(4):240-9.
PubMed 22593636Manson JJ, Rahman A. Systemic lupus erythematosus. Orphanet J Rare Dis. 2006 Mar 27;1:6. doi: 10.1186/1750-1172-1-6.
PubMed 16722594Roberts AL, Rizzolo D. Systemic lupus erythematosus: an update on treat-to-target. JAAPA. 2015 Sep;28(9):22-8. doi: 10.1097/01.JAA.0000470432.76823.93.
PubMed 26251978
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum IL 26 as a Marker of Disease Activity in SLE
- ClinicalTrials.gov ID
- NCT05161988
- Acronym / sponsor ID
- SLE IL26
- Conditions
- SLE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 17 Dec 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.
Assessment of serum Interleukin 26 level in SLE patients and compare it with healthy controls.
Association of serum interleukin 26 with SLE activity and severity.
Detailed description
Systemic lupus erythematosus (SLE) is a chronic inflammatory disease characterized by diverse autoantibodies and varied clinical manifestations(mainly targeting the skin, kidneys, and brain). Autoantibodies directed against double-stranded (ds) DNA play a key role in the initiation and maintenance of inflammatory lesions in SLE(1).
Pathogenesis of SLE is mirrored by its complex aetiopathogenesis as genetic factors , environmental triggers (exposure to sunlight, drugs and infections, particularly with Epstein-Barr virus. . Causing secretion of inflammatory mediators , antibody and cytokines . But still pathological mechanisms of SLE are still not fully understood. (2) Immune system dysregulation such as incomplete clearance of apoptotic materials, hyperactivation of immune cells, overproduction of antibodies and abundant immune complex deposits are prominent in SLE (3) Clinical manifestations of SLE are Malar rash, Discoid rash ,Photosensitivity, Oral or nasopharyngeal ulcers, Pleurisy, Renal abnormalities, Immunologic abnormalities, Nonscarring alopecia, Synovitis, Hemolytic anemia, Leukopenia, Thrombocytopenia Proteinuria Seizures Psychosis Serositis and Arthritis (4) IL-26 is a 171-amino acid protein that belongs to the IL-10 family of cytokines, a family that includes IL-10, IL-19, IL-20, IL-22 and IL-24 . The IL-26 protein is encoded by the IL26 gene located on chromosome 12q15 between genes for interferon (IFN)-γ and IL-22 , and is conserved in several vertebrate species but not in mice and rats . The cytokine IL-26 was originally named AK155(5) IL-26 was initially identified as a pro-inflammatory cytokine , inducing the production of inflammatory cytokines by myeloid cells that are involved in the differentiation of naïve CD4+ T cells into Th17 cells (6) The involvement of IL 26 in numerous chronic auto inflammatory diseases and in two major pathogenic processes in SLE, namely the induction of IFN I and its production by Th 17 lymphocytes, makes the analysis of its role in SLE essential (7) Brilland et al., 2021 report that the levels of IL 26 are higher in SLE patients than healthy subjects and show a significant correlation with disease activity
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients fulfillef the critria o 2012 SLE international collaborating clinics and admition to Assiut University are participate in this study .
Key inclusion criteria (1 listed)
- Adult SLE Patients who fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria
Key exclusion criteria (1 listed)
- Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
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
Assessment of serum interleukin-26 level .
Time frame: baseline
Assessment of serum interleukin-26 level in SLE patients and compare it with the serum interleukin-26 level in healthy
1 secondary outcome
Association !!
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Background: PubMed 10729163Knappe A, Hor S, Wittmann S, Fickenscher H. Induction of a novel cellular homolog of interleukin-10, AK155, by transformation of T lymphocytes with herpesvirus saimiri. J Virol. 2000 Apr;74(8):3881-7. doi: 10.1128/jvi.74.8.3881-3887.2000.
- Background: PubMed 22593636Maidhof W, Hilas O. Lupus: an overview of the disease and management options. P T. 2012 Apr;37(4):240-9.
- Background: PubMed 16722594Manson JJ, Rahman A. Systemic lupus erythematosus. Orphanet J Rare Dis. 2006 Mar 27;1:6. doi: 10.1186/1750-1172-1-6.
- Background: PubMed 26251978Roberts AL, Rizzolo D. Systemic lupus erythematosus: an update on treat-to-target. JAAPA. 2015 Sep;28(9):22-8. doi: 10.1097/01.JAA.0000470432.76823.93.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE, 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 1 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: status not confirmed, as of the sponsor's last update on 17 Dec 2021. 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?
Contact Fatma Al-zahraa M. Abdel-bary, resident (0201014363853, Zahraamustafa22@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of serum interleukin-26 level . (time frame: baseline). 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 NCT05161988, which also lists 4 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 17 Dec 2021.