Soluble Programmed Death 1 (sPD1) is a Diagnostic Biomarker of ILD in Patients With Rheumatoid Arthritis Disease

NCT ID: NCT05105230

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-08-01

Brief Summary

1. Evaluate the levels of serum (sPD1) in RA patients with ILD and those without.

2. Detect subclinical RA-ILD for early diagnosis and management of this devastating manifestation of RA

Detailed Description

Rheumatoid arthritis is a chronic autoimmune disease that is characterized by a systemic inflammatory state that affects joints and other organs .

There are many types of RA-related pulmonary diseases. RA-related pulmonary diseases include airway disease such as bronchiolitis. There are interstitial lung diseases that include non-specific interstitial pneumonitis and usual interstitial pneumonia .

The pathogenesis of RA is multifactorial with contributions from genetic and environmental factors. (CD4+) T-cells is responsible for pro-inflammatory cytokines production and subsequent joint destruction .

The aetiology of RA-ILD may be related to smoking and other factors that activate autoimmunity and the attack of post-transcriptionally modified self-proteins, such as citrullinated peptides. Citrullinated peptide can be produced in the lungs of some patients, causing a pulmonary fibrosis .

Major subtypes of RA-ILD are defined by their histopathological or (HRCT) patterns

. Programmed death-1 belongs to CD28/B7 family and is expressed on the surface of activated T cells, B cells, NK cells, dendritic cells and Treg cells. sPD-1 is the soluble form of PD-1 that is obtained by phosphoric acid hydrolysis of membrane type PD-1 .

Programmed death-1 and its ligands are important negative regulators of the immune system. .

In RA, Persistent synovial T cell activation and inflammation may be reasoned to positive regulators overexpression, aberrant expression of negative regulators or functional antagonism of these molecules by soluble factors .

sPD-1 inhibits the PD-1/PD-L signalling pathway by interacting with PD-Ls and promotes the T cell activation .

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Interventions

soluble programmed death 1biomarker

soluble programmed death 1biomarker

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Adult RA Patients who fulfilled the 2010 ACR/European league against rheumatism (EULAR) criteria for the classification of RA (7).
• Adult RA patients with ILD (Nonspecific idiopathic interstitial pneumonia more than 16 years old).

Exclusion Criteria

• Patients with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa sarcoidosis, dermatomyositis, scleroderma, spondylarthritis and inflammatory bowel disease).
• RA patients with lung affection other than ILD
• Patients with malignant tumors
• Patients with active infection
• Patients with severe heart, lung, and kidney dysfunction
• Patients with tuberculosis, pulmonary infection, chronic obstructive pulmonary disease, bronchiectasis, lung tumor, and pneumoconiosis disease.
• Uses of drugs (other than RA medication) known to cause ILD such as antimicrobial agents (Sulphonamide), cardiovascular agents (amiodarone) and Bromocriptine.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Salwa Omar Mohammed

Resident doctor in Rhematology and rehabilitation department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Salwa omar

Role: CONTACT

salwa8774@gmail.com

01206889948

Rania Mohamed

Role: CONTACT

drraniami@gmail.com

01206620088

Related Links

https://doi.org/10.21203/rs.3.rs-587880/v1

Soluble Programmed Death Molecule 1 (sPD-1) As Predictor of Interstitial Lung Disease in Rheumatoid Arthritis

https://doi.org/10.1016/j.jfma.2020.04.004

The PD-1/PD-L pathway in rheumatic diseases

http://dx.doi.org/10.1016/j.ejr.2014.12.002

Clinical significance of soluble programmed death-1(sPD-1) in rheumatoid arthritis patients: Relation to disease activity and functional status

Other Identifiers

sPD1 in RA

Identifier Type: -

Identifier Source: org_study_id