NCT05161988

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

December 10, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

3 years

First QC Date

December 4, 2021

Last Update Submit

December 16, 2021

Conditions

Outcome Measures

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

    baseline

Secondary Outcomes (1)

  • Association !!

    baseline

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 10729163BACKGROUND
  • Maidhof W, Hilas O. Lupus: an overview of the disease and management options. P T. 2012 Apr;37(4):240-9.

    PMID: 22593636BACKGROUND
  • Manson JJ, Rahman A. Systemic lupus erythematosus. Orphanet J Rare Dis. 2006 Mar 27;1:6. doi: 10.1186/1750-1172-1-6.

    PMID: 16722594BACKGROUND
  • 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.

    PMID: 26251978BACKGROUND

Central Study Contacts

Fatma Al-zahraa M. Abdel-bary, resident

CONTACT

Sherif H. Jalal, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

December 4, 2021

First Posted

December 17, 2021

Study Start

December 10, 2021

Primary Completion

December 1, 2024

Study Completion

May 1, 2025

Last Updated

December 17, 2021

Record last verified: 2021-12