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Not yet recruitingNCT05161988Updated Dec 17, 2021

Serum IL 26 as a Marker of Disease Activity in SLE

An observational study in SLE, sponsored by Assiut University. Not yet recruiting. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-17.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
52
Ages
15 Years to 80 Years
Sex
All
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Study 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 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

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Conditions studied

  • SLE
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In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 80 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Any patients fulfillef the critria o 2012 SLE international collaborating clinics and admition to Assiut University are participate in this study .

Inclusion criteria

  • Adult SLE Patients who fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria

Exclusion criteria

Exclusion Criteria:

  • Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
52 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

Secondary outcomes

  1. Association !!

    Association of serum interleukin 26 with SLE activity and severity.

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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 10729163 ↗
  • Maidhof W, Hilas O. Lupus: an overview of the disease and management options. P T. 2012 Apr;37(4):240-9. PubMed 22593636 ↗
  • Manson JJ, Rahman A. Systemic lupus erythematosus. Orphanet J Rare Dis. 2006 Mar 27;1:6. doi: 10.1186/1750-1172-1-6. PubMed 16722594 ↗
  • Roberts 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05161988
Lead sponsor
Assiut University
Responsible party
Fatma alzahraa Mustafa Abdelbary Thabet (resident, Assiut University) — Principal investigator
First posted
Dec 17, 2021
Start date
Dec 10, 2021 (estimated)
Primary completion
Dec 1, 2024 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Dec 17, 2021

Study contacts

Fatma Al-zahraa M. Abdel-bary, resident
Contact
Zahraamustafa22@yahoo.com
0201014363853
Sherif H. Jalal, professor
Contact
Sherif_h918@hotmail.com
0201222675000

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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