- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04356066
CXCL10 As a Biomarker Of ILD in Patients WithRA
April 20, 2020 updated by: Elzahraa Awny Fathy, Assiut University
CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 .
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Adult Rheumatoid Arthritis Patient with Interstitial Lung Dise
|
serum sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CXCL10 As a Biomarker Of Interstitial Lung Disease in Patients With Rheumatoid Arthritis
Time Frame: 2 years
|
serum level
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 19, 2020
Primary Completion (Anticipated)
January 19, 2021
Study Completion (Anticipated)
January 19, 2022
Study Registration Dates
First Submitted
January 17, 2020
First Submitted That Met QC Criteria
April 20, 2020
First Posted (Actual)
April 22, 2020
Study Record Updates
Last Update Posted (Actual)
April 22, 2020
Last Update Submitted That Met QC Criteria
April 20, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- zahraa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Interstitial Lung Disease in Patients With Rheumatoid Arthritis
-
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-
Brigham and Women's HospitalCompletedRheumatoid Arthritis Interstitial Lung DiseaseUnited States, Canada, Australia, United Kingdom
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Centre Hospitalier Universitaire de NiceUnknownCardiovascular Check-up in Patients With Rheumatoid Arthritis
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Centre Hospitalier Universitaire de LiegeBoehringer IngelheimRecruitingRheumatoid Arthritis-Associated Interstitial Lung DiseaseBelgium
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Assiut UniversityRecruitingRheumatoid Arthritis-Associated Interstitial Lung DiseaseEgypt
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Changchun GeneScience Pharmaceutical Co., Ltd.West China HospitalNot yet recruitingSystemic Sclerosis Associated Interstitial Lung Disease | Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD) | Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)China
-
Polyclinic of the Hospitaller Brothers of St. John...Medical Imaging Centre- Semmelweis University, Faculty of Medicine; Department...RecruitingRheumatoid Arthritis | Interstitial Lung DiseaseHungary
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Hanyang UniversityUnknownRheumatoid Arthritis | Interstitial Lung DiseaseKorea, Republic of
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