Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Anti _KU antibodies
Sponsored by
About this trial
This is an interventional screening trial for Systemic Lupus Erythematosus
Eligibility Criteria
Inclusion Criteria: all patients will fulfill the Systemic Lupus International Clinics(SLICC) classification criteria for Systemic Lupus Erythematosus. Exclusion Criteria: any patient with any collagen disease other than SLE
Sites / Locations
- Sohag University HospitalsRecruiting
Outcomes
Primary Outcome Measures
Anti KU antibodies and its relationship with Systemic Lupus Erythematosus manifestations
the study will evaluate the titre of Anti KU
antibodies which is positive or negative in one patient and on the other side what is the manifestation of SLE that found in the same patient if the Anti KU Antibodies titre is positive
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05900232
Brief Title
Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus
Official Title
Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
systemic lupus Erythematosus (SLE) is a multi system autoimmune disorder abroad spectrum of clinical presentations.
Diagnosis of SLE depending on Systemic Lupus International Collaborating Clinics (SLICC) Criteria.
SLICC Criteria requires either that a patient satisfy at least 4 of 17 Criteria including at least 1 of 11 clinical criteria and 1 of 6 immunological criteria or the patient has biopsy -proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA)or anti_double stranded DNA (dsDNA) antibodies.
Anti_KU antibodies included in (ANA), reported in many autoimmune disorders like SLE,Sjogren syndrome, idiopathic lung fibrosis and myositis.
So the aim of the work is to determine the relationship between Anti_KU antibodies and SLE manifestations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Anti _KU antibodies
Intervention Description
aim of the work is to determine the relationship between Anti_Ku antibodies and SLE manifestations the study will include 60 SLE cases diagnosed by SLICC criteria and the activity of SLE will be calculated by SELDAI criteria, which is tool composed of 24 clinical and laboratory variables.
Primary Outcome Measure Information:
Title
Anti KU antibodies and its relationship with Systemic Lupus Erythematosus manifestations
Description
the study will evaluate the titre of Anti KU
antibodies which is positive or negative in one patient and on the other side what is the manifestation of SLE that found in the same patient if the Anti KU Antibodies titre is positive
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients will fulfill the Systemic Lupus International Clinics(SLICC) classification criteria for Systemic Lupus Erythematosus.
Exclusion Criteria:
any patient with any collagen disease other than SLE
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nehal A Ahmed, resident
Phone
01145379717
Email
nehal011209@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Osama S Daifallah, Associate Professor
Facility Information:
Facility Name
Sohag University Hospitals
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, Professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
17083771
Citation
Mosca M, Bombardieri S. Assessing remission in systemic lupus erythematosus. Clin Exp Rheumatol. 2006 Nov-Dec;24(6 Suppl 43):S-99-104.
Results Reference
background
PubMed Identifier
22553077
Citation
Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
Results Reference
background
PubMed Identifier
22129255
Citation
Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.
Results Reference
background
PubMed Identifier
12521194
Citation
Mimori T. Clinical significance of anti-Ku autoantibodies--a serologic marker of overlap syndrome? Intern Med. 2002 Dec;41(12):1096-8. doi: 10.2169/internalmedicine.41.1096. No abstract available.
Results Reference
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Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus
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