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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Interstitial Lung Disease in Patients With Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    January 17, 2020
    Last Updated
    April 20, 2020
    Sponsor
    Assiut University
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    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
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    CXCL10 As a Biomarker Of ILD in Patients WithRA

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