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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04356066
Other study ID # zahraa
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 19, 2020
Est. completion date January 19, 2022

Study information

Verified date January 2020
Source Assiut University
Contact Naima Mohamed Mostafa, professor doctor
Phone 01223947372
Email naimamohamed21@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rheumatoid arthritis is a chronic inflammatory disease that affects the joints, causing symmetric pain, stiffness, swelling, and limited motion and function of multiple joints, its fibro inflammatory manifestations may develop in other organs.


Description:

Rheumatoid arthritis is complicated by lung manifestations, such as interstitial lung disease which is the most common cause of morbidity and mortality in rheumatoid arthritis patients. Rheumatoid arthritis-interstitial lung disease is a progressive fibrotic disease of the lung parenchyma that includes a broad spectrum of disorders such as nonspecific interstitial pneumonia, usual interstitial pneumonia , desquamative interstitial pneumonia, cryptogenic organizing pneumonia, diffuse alveolar damage, acute interstitial pneumonia, and lymphocytic interstitial pneumonia . Rheumatoid arthritis-interstitial lung disease in which available data indicate that dysregulated inflammatory cascades can elaborate a host of cytokines, chemokines, and growth factors that collectively promote epithelial and endothelial cell damage, angiogenesis, fibroblast differentiation/proliferation, and lung fibrosis . Given the clinical implications of putative signaling cascades involved in these processes, biomarkers that can be used to clarify disease pathogenesis and identify factors governing disease progression are clearly needed .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date January 19, 2022
Est. primary completion date January 19, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Adult rheumatoid arthritis patients who fulfilled the 2010 American College of Rheumatology/European league against rheumatism criteria for the classification of Rheumatoid Arthritis.

2. Adult rheumatoid arthritis patients with interstitial lung disease.

Exclusion Criteria:

1. Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis and inflammatory bowel disease).

2. Individuals with hepatitis, Rhinovirus infection, cerebral malaria.

3. Individuals with colorectal carcinoma, syndrome of frailty, vetiligo.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
serum cxcl10 by ELISA
serum sample

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

1. Chen J, Doyle TJ, Liu Y, et al. Biomarkers of rheumatoid arthritis-associated interstitial lung disease. Arthritis Rheumatol. 2015;67(1):28-38. doi:10.1002/art.38904 2. Richards TJ, Eggebeen A, Gibson K, et al. Characterization and peripheral blood bio

Outcome

Type Measure Description Time frame Safety issue
Primary CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis serum level 2 years