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

NCT05105230 | Unknown

• 1 other identifier: sPD1 in RA
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Evaluate the levels of serum (sPD1) in RA patients with ILD and those without.
2. 2.Detect subclinical RA-ILD for early diagnosis and management of this devastating manifestation of RA

Conditions

Rheumatoid Arthritis

Keywords

Interstitial lung disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• early diagnosis of ILD in patients with RA

  baseline

Interventions

soluble programmed death 1biomarker DIAGNOSTIC_TEST

soluble programmed death 1biomarker

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related 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

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Salwa omar

CONTACT

01206889948; salwa8774@gmail.com

Rania Mohamed

CONTACT

01206620088; drraniami@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor in Rhematology and rehabilitation department

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 3, 2021
• Study Start: March 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 12, 2022

Record last verified: 2022-01