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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Diagnostic test: soluble programmed death 1biomarker

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 .

• Study Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

• Study Contact: Name: Salwa omar; Phone Number: 01206889948; Email: salwa8774@gmail.com
• Study Contact Backup: Name: Rania Mohamed; Phone Number: 01206620088; Email: drraniami@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Adult RA Patients
2. Adult RA patients with ILD
3. Adult healthy control

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure the levels of serum (sPD1)by ELISA in RA patients	Evaluate the levels of serum (sPD1) in RA patients and its correlation with ILD	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early diagnosis of ILD in patients with RA	Detect subclinical RA-ILD for early diagnosis and management of this devastating manifestation	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Soluble Programmed Death Molecule 1 (sPD-1) As Predictor of Interstitial Lung Disease in Rheumatoid Arthritis
• The PD-1/PD-L pathway in rheumatic diseases
• Clinical significance of soluble programmed death-1(sPD-1) in rheumatoid arthritis patients: Relation to disease activity and functional status

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Interstitial lung disease
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: sPD1 in RA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No