Clinical and Diagnostic Value of Ribosomal p2 Autoantibodies in Systemic Lupus Erythematosus

February 22, 2022 updated by: Menna Allah Nashaat, Assiut University

Clinical and Diagnostic Value of Ribosomal p2 Autoantibodies in Systemic Lupus Erythematosus: Case Control Study

Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder characterized by production of autoantibodies directed against nuclear and cytoplasmic antigens. Clinically, this disorder is characterized by periods of remission and relapse (1). The early and accurate diagnosis of SLE is challenging (2).

The SLE pathogenesis involves multiple cellular components of the innate and immune systems, presence of autoantibodies and immune complexes, engagement of the complement system and cytokine dysregulation (3). About 180 autoantibodies have been identified in SLE patients, 102 of which are reported to have an organ-specific correlation with SLE disease identified in SLE patients, with SLE disease activity (4). However, with the exception of autoantibodies such as antinuclear antibody (ANA), anti double stranded DNA (dsDNA), anti-smith and antiphospholipid antibodies, currently proposed by the American college of rheumatology (ACR) (5)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

systemic lupus international collaborating clinics (SLICC) (6) for the diagnosis of SLE, most of these autoantibodies lack sufficient sensitivity and/or specificity for use in clinical diagnosis. Discovery of additional autoantibodies with high sensitivity and specificity is important for early diagnosis and assessment of the prognosis of SLE (7).

Anti-ribosomal P(Anti-Rib-P) antibody, routinely tested in SLE, targets a homologous 22-amino acid C-terminal (C-22) sequence shared by three ribosomal phosphoproteins known as P0, P1, and P2 (8).

The prevalence of anti-Rib-P antibody is about 15-40% in SLE patients and varies with the ethnicity, disease activity and detection method (9). Studies have disclosed that anti-P antibodies react with activated T cells but not with B cells, suggesting possible direct effects of anti-P antibodies on immune regulation (10).

Study Type

Observational

Enrollment (Anticipated)

90

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

Study Contact Backup

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

SLE pts obtained from rheumatology clinic in assiut university hospital >= 18 years

Description

Inclusion Criteria:

  1. Patients who fulfilled the 2012 SLICC criteria (6).
  2. SLE Patients >= 18 years old.

Exclusion Criteria:

  • 1-SLE Patients < 18 years old. 2- Patients with other autoimmune diseases or malignancy.

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SLE patients group
The study will include 50 patients suffering from SLE, all patients with SLE should fulfill 2012 SLICC criteria
Diagnostic test: Ribosomal p2 Autoantibodies as a Serum marker
Using serum marker
Healthy control group
Control group of 40 healthy volunteers with age and gender-matched with SLE patients.
Diagnostic test: Ribosomal p2 Autoantibodies as a Serum marker
Using serum marker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a. Primary (main): Assessment of diagnostic value (sensitivity and specificity) of serum ribosomal p2 autoantibody level in SLE patients in comparison to healthy controls
Time Frame: Baseline
The importance of Ribosomal p2 autoantibodies in diagnosis of SLE
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
b. Secondary (subsidiary): correlation between serum ribosomal p2 autoantibody level and SLE clinical, laboratory data, disease activity and severity.
Time Frame: Baseline
The relation between rib p2 level in serum and determination of disease severity and prognosis
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Samar Hassanein goma, MD, Assiut University Egypt
  • Study Director: Maha Sayed ibrahim, MD, Assiut University Egypt

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

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 (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

December 18, 2021

First Submitted That Met QC Criteria

December 18, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rib P2 antibodies in sle pts

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.

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