- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06713187
Interleukin23 in Systemic Lupus
November 27, 2024 updated by: khadiga Mahmoud Salem, Sohag University
Role of Interleukin 23 in Systemic Lupus Erythematosus Related Interstial Lung Disease
assement of interleukin 23 in serum of patients with systemic lupus erythematosus related interstial lung disease .
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
for all patients detailed history taken clinical and rhumatological examination will be assessed and SLEDAI score will be collected from the case record of the patients&laboratory investigation included 1_erythrocytic sedimentation rate.2_complete
blood count.3_interleukin23
.4_complement
3&4.5_Antinuclear
Antibodies.6_Anti double stranded antibodies.7_full
basic biochemical test(24 urine protien)8_high resolution computed tomography.
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Khadiga M Salem, resident doctor
- Phone Number: 01069152448
- Email: khadiga_mahmoud_post@med.sohag.edu.eg
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University
-
Contact:
- Magdy M Ameen, Professor
- Phone Number: 0934602963
- Email: ethics@med.sohag.edu.eg
-
Sohag, Egypt
- Recruiting
- Sohag university hospital
-
Contact:
- Magdy M Ameen, Professor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- patients with systemic lupus erythematous and patients with systemic lupus erythematosus with interstial lung disease.
Exclusion Criteria:
- patients with chest conditions rather than interstial lung disease &who receiving biological blocking antibodies& those treated with immunosuppressive drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group 1
Patients with systemic lupus erythematosus without interstial lung disease.
|
assessment of interleukin 23 in Sera of patients using ELIZA
|
|
Active Comparator: group2
Patients with systemic lupus erythematosus with interstial lung disease.
|
assessment of interleukin 23 in Sera of patients using ELIZA
|
|
Active Comparator: group3
healthy control groups
|
assessment of interleukin 23 in Sera of patients using ELIZA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
interleukin 23
Time Frame: 2 years
|
level of interleukin 23 in Sera of patients with systemic lupus erythematosus using ELIZA
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yap DY, Lai KN. Cytokines and their roles in the pathogenesis of systemic lupus erythematosus: from basics to recent advances. J Biomed Biotechnol. 2010;2010:365083. doi: 10.1155/2010/365083. Epub 2010 May 6.
- Haroon MM, Hegazy GA, Hassanien MA, Shaker O, Hussein WH. Significance of Interleukin 23 in Systemic Lupus Patients: Relation to Disease Activity and Damage Indices. Biologics. 2023 Jan 18;17:1-9. doi: 10.2147/BTT.S389021. eCollection 2023.
- Sisto M, Lisi S. Interleukin-23 Involved in Fibrotic Autoimmune Diseases: New Discoveries. J Clin Med. 2023 Sep 1;12(17):5699. doi: 10.3390/jcm12175699.
- Senoo S, Taniguchi A, Itano J, Oda N, Morichika D, Fujii U, Guo L, Sunami R, Kanehiro A, Tokioka F, Yoshimura A, Kiura K, Maeda Y, Miyahara N. Essential role of IL-23 in the development of acute exacerbation of pulmonary fibrosis. Am J Physiol Lung Cell Mol Physiol. 2021 Nov 1;321(5):L925-L940. doi: 10.1152/ajplung.00582.2020. Epub 2021 Sep 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2025
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
November 27, 2024
First Submitted That Met QC Criteria
November 27, 2024
First Posted (Actual)
December 3, 2024
Study Record Updates
Last Update Posted (Actual)
December 3, 2024
Last Update Submitted That Met QC Criteria
November 27, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh_Med__24_11_09MS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.