跳至主要内容
临床试验/NCT05105230
NCT05105230Unknown不适用

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

Assiut University0 个研究点目标入组 66 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
66
主要终点
measure the levels of serum (sPD1)by ELISA in RA patients

研究概览

简要总结

  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

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

measure the levels of serum (sPD1)by ELISA in RA patients

时间窗: baseline

Evaluate the levels of serum (sPD1) in RA patients and its correlation with ILD

次要结局

  • early diagnosis of ILD in patients with RA(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salwa Omar Mohammed

Resident doctor in Rhematology and rehabilitation department

Assiut University

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