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Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis

Primary Purpose

Rheumatoid Arthritis and Osteoarthritis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
serum calprotectin
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis and Osteoarthritis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult RA Patients who fulfilled the 2010 ACR/European league against rheumatism (EULAR) criteria for the classification of RA
  2. Adult osteoarthritis patients who fulfilled 2016 ACR revised Criteria for early diagnosis of knee OA

Exclusion Criteria:

  1. Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis, behcet's disease, psoriasis and inflammatory bowel disease).
  2. RA patients with interstitial lung disease (IPF).
  3. Patients with malignancy.
  4. Patients with end stage organ failure.
  5. Other conditions that may affect the serum level of calprotectin as diabetes mellitus, coronary artery disease, hepatitis and concomitant inflammatory disease as acute infection or chronic inflammatory status.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    RA patients

    OA patients

    Arm Description

    A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)

    A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)

    Outcomes

    Primary Outcome Measures

    • Assessment of sensitivity and specificity of the serum calprotectin as an indicator of disease activity in both RA and OA patients.
    Analysis of serum level of calprotectin in both Rheumatoid arthritis and Osteoarthritis patients as an indicator of disease activity

    Secondary Outcome Measures

    Compare between sensitivity and specificity of the serum calprotectin in detecting the activity of disease in both RA (Autoimmune inflammatory disease) and OA (Degenerative inflammatory disease)
    Compare between sensitivity and specificity of the serum calprotectin in detecting the activity of disease in both RA (Autoimmune inflammatory disease) and OA (Degenerative inflammatory disease)

    Full Information

    First Posted
    December 14, 2019
    Last Updated
    December 16, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04201886
    Brief Title
    Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis
    Official Title
    Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    October 2020 (Anticipated)
    Study Completion Date
    October 2021 (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

    5. Study Description

    Brief Summary
    Assessment of the serum level of calprotectin in patients with rheumatoid arthritis and osteoarthritis.
    Detailed Description
    Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with genetic susceptibility. It is characterized by chronic synovitis and progressive joint destruction. There is synovial infiltration by inflammatory cells, activation of synovial fibroblasts, and production of a wide range of inflammatory cytokines. Sustained high disease activity results in a poor disease outcome so assessment of inflammatory activity in RA is of pivotal importance for the optimal treatment in these patients. Disease activity of RA patients is assessed by clinical examination, laboratory tests and radiographic assessment (e.g. ultrasonography). Laboratory assessment of RA activity is done routinely by measuring acute phase reactants such as an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), which are elevated in most patients with RA. It has been demonstrated that more than 40% of RA patients have normal ESR or CRP (false negative results). Therefore, new serum markers that can more accurately reflect real inflammatory activity in RA patients are needed. Calprotectin (CLP) is a calcium binding leucocyte protein consisting of the heterocomplex of S100A8/ A9 (myeloid-related protein, MRP8/MRP14), as well as being a major monocyte/macrophage protein which has gained interest as a marker of inflammation in RA. Calprotectin has been identified as an important endogenous alarmin, one of the damage-associated molecular pattern (DAMP) molecules that acts as a ligand for the TLR4 receptor and amplifies the inflammation cascade via NF-kB and p38 mitogen-activated protein kinase. Calprotectin levels are higher in the serum of RA patients compared with healthy subjects or patients with osteoarthritis (OA), Still, no cut-off levels have been identified to help in the diagnosis of RA. Calprotectin is involved in cartilage damage in OA. Synovial lining macrophages play a role in the OA process and in cartilage damage. Moderate calprotectin increase has been observed in the serum of OA patients compared with healthy controls also serum calprotectin levels were found higher in OA patients with synovial inflammation compared with those without.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis and Osteoarthritis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RA patients
    Arm Type
    Other
    Arm Description
    A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)
    Arm Title
    OA patients
    Arm Type
    Other
    Arm Description
    A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)
    Intervention Type
    Other
    Intervention Name(s)
    serum calprotectin
    Intervention Description
    serum calcium binding leucocyte protein
    Primary Outcome Measure Information:
    Title
    • Assessment of sensitivity and specificity of the serum calprotectin as an indicator of disease activity in both RA and OA patients.
    Description
    Analysis of serum level of calprotectin in both Rheumatoid arthritis and Osteoarthritis patients as an indicator of disease activity
    Time Frame
    a year
    Secondary Outcome Measure Information:
    Title
    Compare between sensitivity and specificity of the serum calprotectin in detecting the activity of disease in both RA (Autoimmune inflammatory disease) and OA (Degenerative inflammatory disease)
    Description
    Compare between sensitivity and specificity of the serum calprotectin in detecting the activity of disease in both RA (Autoimmune inflammatory disease) and OA (Degenerative inflammatory disease)
    Time Frame
    a year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult RA Patients who fulfilled the 2010 ACR/European league against rheumatism (EULAR) criteria for the classification of RA Adult osteoarthritis patients who fulfilled 2016 ACR revised Criteria for early diagnosis of knee OA Exclusion Criteria: Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis, behcet's disease, psoriasis and inflammatory bowel disease). RA patients with interstitial lung disease (IPF). Patients with malignancy. Patients with end stage organ failure. Other conditions that may affect the serum level of calprotectin as diabetes mellitus, coronary artery disease, hepatitis and concomitant inflammatory disease as acute infection or chronic inflammatory status.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tayseer Mohammed Mahmoud, Prof.
    Phone
    01006061809
    Email
    dr.tayseeer@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Safaa Ali Gamal Al-din, Ass. Prof.
    Phone
    01003385106
    Email
    safaa69@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mona Hussien Abd El-Samea, Dr.
    Organizational Affiliation
    Assiut university hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    •Salehi Abari and Iraj. 2016 ACR revised criteria for early diagnosis of knee osteoarthritis. Autoimmune diseases and therapeutic approaches 2016; 3. 118.
    Results Reference
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    Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis

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