Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus

NCT ID: NCT05900232

Last Updated: 2023-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2023-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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Anti _KU antibodies

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Nehal Abdelbasset Ahmed

Resident Doctor at Rheumatology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospitals

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nehal A Ahmed, resident

Role: CONTACT

01145379717

Osama S Daifallah, Associate Professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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

Reference Type BACKGROUND
PMID: 17083771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22553077 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 22129255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12521194 (View on PubMed)

Other Identifiers

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Soh-Med-23-05-05MD

Identifier Type: -

Identifier Source: org_study_id

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