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CTHRC1: A Biomarker for Evaluation of Rheumatoid Arthritis Disease Activity

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ClinicalTrials.gov Identifier: NCT04415502
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Lobna Amer Araby Ahmed, Assiut University

Study Description
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Brief Summary:
The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity

Condition or disease
Rheumatoid Arthritis

Detailed Description:
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease of synovial joints. Characterized by periods of flares with high disease activity involving both a systemic immune response and tissue-specific inflammatory events that can lead to erosive joint and bone destruction and subsequent disability . Currently, diagnosis of RA is based mainly on the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as C-reactive protein (CRP) ,erythrocyte sedimentation rate(ESR) , high titers of rheumatoid factor (RF) and high titers of antibodies against cyclic citrullinated peptide (anti-CCP) in the plasma .Recently, reported increased levels of collagen triple helix repeat containing 1 protein (CTHRC1) are strongly associated with the severity of murine proteoglycan-induced arthritis and collagen antibody-induced murine arthritis (CAIA) , further CTHRC1 expression in murine experimental arthritis is increased in the synovium and specifically detected in activated murine , located at the synovial intimal lining and at the bone-pannus interface .Of interest,The expression pattern of CTHRC1 in pannus, its role in the function of FLS relevant to cartilage damage in RA, and CTHRC1's association with disease severity in murine arthritis raised the question of whether CTHRC1 could be used as a marker for RA diagnosis and monitoring of disease activity in patients .
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: CTHRC1: A Biomarker for Evaluation of Rheumatoid Arthritis Disease Activity
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : May 1, 2021

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Groups and Cohorts
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Group/Cohort
Measuring of CTHRc1 , its correlation with RAdisease activity
Measuring of CTHRc1 levels and its correlation with RA disease activity


Outcome Measures
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Primary Outcome Measures :
  1. CTHRC1 in RA [ Time Frame: One year ]
    Measuring of CTHRc1 in Rheumatoid arthritis patients.

  2. CTHRc1 and RA disease activity [ Time Frame: One year ]
    Correlation of CTHRc1levels with RA disease activity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Measuring of CTHRc1 levels and its correlation with RA disease activity
Criteria

Inclusion Criteria:

  • patients diagnosed as RA
  • age more than 18 years

Exclusion Criteria:

  • other rheumatological diseases Malignancies Hepatic diseases
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415502


Contacts
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Contact: Lobna Amer Araby Ahmed, Master 01019313530 Lobnaamer20@gmail.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Lobna Amer Araby Ahmed, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04415502    
Other Study ID Numbers: CTHRC1 in RA
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases