Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus

NCT05900232 | Unknown

• 1 other identifier: Soh-Med-23-05-05MD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Interventions

Anti _KU antibodies DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all patients will fulfill the Systemic Lupus International Clinics(SLICC) classification criteria for Systemic Lupus Erythematosus.

You may not qualify if:

• any patient with any collagen disease other than SLE

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, Egypt

RECRUITING

Related Publications (4)

• Mosca M, Bombardieri S. Assessing remission in systemic lupus erythematosus. Clin Exp Rheumatol. 2006 Nov-Dec;24(6 Suppl 43):S-99-104.

  PMID: 17083771 BACKGROUND

• 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.

  PMID: 22553077 BACKGROUND

• Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.

  PMID: 22129255 BACKGROUND

• 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.

  PMID: 12521194 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Nehal A Ahmed, resident

CONTACT

01145379717; nehal011209@med.sohag.edu.eg

Osama S Daifallah, Associate Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor at Rheumatology Department

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: June 12, 2023
• Study Start: May 15, 2023
• Primary Completion: October 15, 2023
• Study Completion: November 1, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Locations

EG (1)