CXCL10 As a Biomarker Of ILD in Patients WithRA
Primary Purpose
Interstitial Lung Disease in Patients With Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
serum cxcl10 by ELISA
Sponsored by
About this trial
This is an interventional other trial for Interstitial Lung Disease in Patients With Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Adult rheumatoid arthritis patients who fulfilled the 2010 American College of Rheumatology/European league against rheumatism criteria for the classification of Rheumatoid Arthritis.
- Adult rheumatoid arthritis patients with interstitial lung disease.
Exclusion Criteria:
- Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis and inflammatory bowel disease).
- Individuals with hepatitis, Rhinovirus infection, cerebral malaria.
- Individuals with colorectal carcinoma, syndrome of frailty, vetiligo.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Adult Rheumatoid Arthritis Patient with Interstitial Lung Dise
Arm Description
History taking: age, sex, disease duration, history of present illness, drug intake, past and family history. Physical examination including thorough clinical examination. Health assessment questionnaire-disability index (HAQ-DI): It is used as a subjective measure of physical function of RA patients (Pincus et al., 1983). There are 20 items in 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities (Jessica et al., 2018).
Outcomes
Primary Outcome Measures
CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis
serum level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04356066
Brief Title
CXCL10 As a Biomarker Of ILD in Patients WithRA
Official Title
CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2020 (Anticipated)
Primary Completion Date
January 19, 2021 (Anticipated)
Study Completion Date
January 19, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease in Patients With Rheumatoid Arthritis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adult Rheumatoid Arthritis Patient with Interstitial Lung Dise
Arm Type
Other
Arm Description
History taking: age, sex, disease duration, history of present illness, drug intake, past and family history.
Physical examination including thorough clinical examination.
Health assessment questionnaire-disability index (HAQ-DI): It is used as a subjective measure of physical function of RA patients (Pincus et al., 1983). There are 20 items in 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities (Jessica et al., 2018).
Intervention Type
Diagnostic Test
Intervention Name(s)
serum cxcl10 by ELISA
Intervention Description
serum sample
Primary Outcome Measure Information:
Title
CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis
Description
serum level
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult rheumatoid arthritis patients who fulfilled the 2010 American College of Rheumatology/European league against rheumatism criteria for the classification of Rheumatoid Arthritis.
Adult rheumatoid arthritis patients with interstitial lung disease.
Exclusion Criteria:
Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis and inflammatory bowel disease).
Individuals with hepatitis, Rhinovirus infection, cerebral malaria.
Individuals with colorectal carcinoma, syndrome of frailty, vetiligo.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naima Mohamed Mostafa, professor doctor
Phone
01223947372
Email
naimamohamed21@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Samar Hassanein Goma, Ass Prof
Phone
01061828586
Email
Samarhassanein2010@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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 biomarker assessment of anti-Jo-1 antibody-positive interstitial lung disease. Arthritis Rheum. 2009;60(7):2183-2192. doi:10.1002/art.24631 3. Amigues I, Ramadurai D, Swigris JJ. Current Perspectives On Emerging Biomarkers For Rheumatoid Arthritis-Associated Interstitial Lung Disease. Open Access Rheumatol. 2019;11:229-235. Published 2019 Oct 15. doi:10.2147/OARRR.S166070 4. Vij R, Strek ME. Diagnosis and treatment of connective tissue disease-associated interstitial lung disease. Chest. 2013;143(3):814-824. doi:10.1378/chest.12-0741 5. Castelino FV, Varga J. Interstitial lung disease in connective tissue diseases: evolving concepts of pathogenesis and management. Arthritis Res Ther. 2010;12(4):213. doi:10.1186/ar3097 6. Laragione T, Brenner M, Sherry B, Gulko PS. CXCL10 and its receptor CXCR3 regulate synovial fibroblast invasion in rheumatoid arthritis. Arthritis Rheum. 2011;63(11):3274-3283. doi:10.1002/art.30573 7. Gao B, Lin J, Jiang Z, et al. Upregulation of chemokine CXCL10 enhances chronic pulmonary inflammation in tree shrew collagen-induced arthritis. Sci Rep. 2018;8(1):9993. Published 2018 Jul 3. doi:10.1038/s41598-018-28404-y
Results Reference
result
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CXCL10 As a Biomarker Of ILD in Patients WithRA
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