<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04416997</url>
  </required_header>
  <id_info>
    <org_study_id>HRA</org_study_id>
    <nct_id>NCT04416997</nct_id>
  </id_info>
  <brief_title>Rheumatoid Arthritis Hematological Indices</brief_title>
  <official_title>Hematological Indices in Rheumatoid Arthritis and Its Association With Disease Activity and Severity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rheumatoid arthritis is a chronic systemic inflammatory and autoimmune disease, characterized&#xD;
      by disordered immunity, not regulated cytokines and inflammatory infiltration of the synovial&#xD;
      joints. It is the most common inflammatory erosive poly arthritis affecting around 0.5-1% of&#xD;
      the worldwide population which leads to joint damage and disability&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The etiology of Rheumatoid arthritis is complex, it is established that the gene&#xD;
      environmental interaction plays critical roles in the pathology of Rheumatoid arthritis, in&#xD;
      addition to smoking, lifestyle, and hormones.&#xD;
&#xD;
      The lesion is mainly concentrated in the synovial tissue, cartilage, and bone. Inflammation&#xD;
      is the primary cause of joint deformation and limited joint mobility in Rheumatoid arthritis&#xD;
      patients. As the disease progresses, the risk of bone damage and cartilage destruction&#xD;
      increases, leading to substantial disability.&#xD;
&#xD;
      The activity of the disease in Rheumatoid arthritis patients is assessed by clinical&#xD;
      examination, laboratory tests and radio graphic assessment. Laboratory assessment of&#xD;
      Rheumatoid arthritis activity is done routinely by measuring acute phase reactants such as an&#xD;
      erythrocyte sedimentation rate and C-reactive protein, which are elevated in active&#xD;
      Rheumatoid arthritis patients.&#xD;
&#xD;
      Albumin is the major plasma protein and its determination is used for the prognostic&#xD;
      assessment of several diseases. It is a routine marker reflecting both nutritional status and&#xD;
      systemic inflammation, and the synthesis of albumin can be suppressed by systematic&#xD;
      inflammation and malnutrition.&#xD;
&#xD;
      It was reported that the level of albumin was decreased in Rheumatoid arthritis patients.&#xD;
      This low concentration of albumin in Rheumatoid arthritis patients may owing to excessive&#xD;
      albumin consumption caused by inflammatory substances.&#xD;
&#xD;
      Red blood cell distribution width is a parameter that reflects the heterogeneity of&#xD;
      erythrocyte volume, expressed as the coefficient of variation of red blood cell volume. It is&#xD;
      mainly used to differentiate types of anemia. However, some studies have shown that an&#xD;
      elevated Red blood cell distribution was positively correlated with the level of&#xD;
      inflammation.&#xD;
&#xD;
      Red blood cell distribution was increased in patients with Rheumatoid arthritis, which was&#xD;
      associated with inflammation, suggesting that Red blood cell distribution may be a potential&#xD;
      auxiliary marker for indicating inflammation process in Rheumatoid arthritis conveniently.&#xD;
&#xD;
      In subjects with articular pain, Red blood cell distribution interpretation is a useful tool&#xD;
      in clinical practice to distinguish between articular inflammatory and non-inflammatory joint&#xD;
      diseases, as with C-reactive protein. Red blood cell distribution seems to be a surrogate&#xD;
      marker of the inflammatory process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">January 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 29, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of level of Red blood cell distribution width</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Red blood cell distribution width will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of level of serum Albumin in Rheumatoid arthritis patients</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The level of serum Albumin will be measured in Rheumatoid arthritis patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The relation between Red blood cell distribution width and level of serum albumin in RA patients and association with the disease activity and severity.</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Comparing between the Level of Red blood cell distribution width and level of serum albumin in RA patients, then comparing these results with the other routine parameters of these patients.&#xD;
Activity index will be done: Disease activity score (DAS28) DAS28 score of higher than 5.1 is indicative of high disease activity, DAS28 score of higher than 3.2 indicate moderate disease activity whereas DAS28 score below 3.2 indicates low disease activity. Patients are considered to be in remission if they have DAS28 score lower than 2.6 Health assessment questionnaire-disability index (HAQ-DI) will be done, It is used as a subjective measure of physical function of RA patients .There are 20 items in 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Serum Albumin Low</condition>
  <arm_group>
    <arm_group_label>Rheumatoid arthritis patients</arm_group_label>
    <description>Blood and serum samples</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood and serum samples</intervention_name>
    <description>The blood and serum samples will taken from RA patients</description>
    <arm_group_label>Rheumatoid arthritis patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and serum samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include adult RA patients consecutively presented at the Rheumatology,&#xD;
        Rehabilitation and Physical Medicine Department, Assiut University Hospitals from both&#xD;
        inpatient department and outpatient clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult RA Patients who fulfilled the 2010 European league against rheumatism criteria&#xD;
             for the classification of RA&#xD;
&#xD;
        Exclusion Criteria:1. Individuals with concomitant other autoimmune diseases 2. RA patients&#xD;
        with anemia, pregnancy, postpartum, diabetes, obesity hypertension.&#xD;
&#xD;
        3. Patients with age less than 18 years 4. Patients with end stage organ failure.&#xD;
&#xD;
        5. Patients with liver diseases.&#xD;
&#xD;
        6. Patients with hematological disorders.&#xD;
&#xD;
        7. Patients with malignancies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Fatma Meligy, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>FYMeligy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of medicine</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eman Alkady, Prof</last_name>
      <phone>01015553905</phone>
      <phone_ext>002</phone_ext>
      <email>eman_alkady@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Mona Abd El-Hafez, Dr</last_name>
      <phone>01062909909</phone>
      <phone_ext>002</phone_ext>
      <email>Re_mo_h@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Alpizar-Rodriguez D, Finckh A. Environmental factors and hormones in the development of rheumatoid arthritis. Semin Immunopathol. 2017 Jun;39(4):461-468. doi: 10.1007/s00281-017-0624-2. Epub 2017 Apr 27.</citation>
    <PMID>28451785</PMID>
  </results_reference>
  <results_reference>
    <citation>Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461. Erratum In: Ann Rheum Dis. 2010 Oct;69(10):1892.</citation>
    <PMID>20699241</PMID>
  </results_reference>
  <results_reference>
    <citation>Yan F, Li H, Zhong Z, Zhou M, Lin Y, Tang C, Li C. Co-Delivery of Prednisolone and Curcumin in Human Serum Albumin Nanoparticles for Effective Treatment of Rheumatoid Arthritis. Int J Nanomedicine. 2019 Nov 22;14:9113-9125. doi: 10.2147/IJN.S219413. eCollection 2019.</citation>
    <PMID>31819422</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Fatma Yassine Meligy</investigator_full_name>
    <investigator_title>Princible investigator</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>Red blood cell distribution</keyword>
  <keyword>Albumin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>study the relation between RDW and level of serum albumin in RA patients and association with the disease activity and severity.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04416997
org study id: HRA
nct id: NCT04416997
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rheumatoid arthritis is a chronic systemic inflammatory and autoimmune disease, characterized
      by disordered immunity, not regulated cytokines and inflammatory infiltration of the synovial
      joints. It is the most common inflammatory erosive poly arthritis affecting around 0.5-1% of
      the worldwide population which leads to joint damage and disability
The etiology of Rheumatoid arthritis is complex, it is established that the gene
      environmental interaction plays critical roles in the pathology of Rheumatoid arthritis, in
      addition to smoking, lifestyle, and hormones.

      The lesion is mainly concentrated in the synovial tissue, cartilage, and bone. Inflammation
      is the primary cause of joint deformation and limited joint mobility in Rheumatoid arthritis
      patients. As the disease progresses, the risk of bone damage and cartilage destruction
      increases, leading to substantial disability.

      The activity of the disease in Rheumatoid arthritis patients is assessed by clinical
      examination, laboratory tests and radio graphic assessment. Laboratory assessment of
      Rheumatoid arthritis activity is done routinely by measuring acute phase reactants such as an
      erythrocyte sedimentation rate and C-reactive protein, which are elevated in active
      Rheumatoid arthritis patients.

      Albumin is the major plasma protein and its determination is used for the prognostic
      assessment of several diseases. It is a routine marker reflecting both nutritional status and
      systemic inflammation, and the synthesis of albumin can be suppressed by systematic
      inflammation and malnutrition.

      It was reported that the level of albumin was decreased in Rheumatoid arthritis patients.
      This low concentration of albumin in Rheumatoid arthritis patients may owing to excessive
      albumin consumption caused by inflammatory substances.

      Red blood cell distribution width is a parameter that reflects the heterogeneity of
      erythrocyte volume, expressed as the coefficient of variation of red blood cell volume. It is
      mainly used to differentiate types of anemia. However, some studies have shown that an
      elevated Red blood cell distribution was positively correlated with the level of
      inflammation.

      Red blood cell distribution was increased in patients with Rheumatoid arthritis, which was
      associated with inflammation, suggesting that Red blood cell distribution may be a potential
      auxiliary marker for indicating inflammation process in Rheumatoid arthritis conveniently.

      In subjects with articular pain, Red blood cell distribution interpretation is a useful tool
      in clinical practice to distinguish between articular inflammatory and non-inflammatory joint
      diseases, as with C-reactive protein. Red blood cell distribution seems to be a surrogate
      marker of the inflammatory process.
observational model: Other
time perspective: Other
measure: Assessment of level of Red blood cell distribution width
time frame: Through study completion, an average of 1 year
description: Red blood cell distribution width will be measured.
measure: Assessment of level of serum Albumin in Rheumatoid arthritis patients
time frame: Through study completion, an average of 1 year
description: The level of serum Albumin will be measured in Rheumatoid arthritis patients
measure: The relation between Red blood cell distribution width and level of serum albumin in RA patients and association with the disease activity and severity.
time frame: Through study completion, an average of 1 year
description: Comparing between the Level of Red blood cell distribution width and level of serum albumin in RA patients, then comparing these results with the other routine parameters of these patients.
Activity index will be done: Disease activity score (DAS28) DAS28 score of higher than 5.1 is indicative of high disease activity, DAS28 score of higher than 3.2 indicate moderate disease activity whereas DAS28 score below 3.2 indicates low disease activity. Patients are considered to be in remission if they have DAS28 score lower than 2.6 Health assessment questionnaire-disability index (HAQ-DI) will be done, It is used as a subjective measure of physical function of RA patients .There are 20 items in 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.
arm group label: Rheumatoid arthritis patients
description: Blood and serum samples
intervention type: Procedure
intervention name: Blood and serum samples
description: The blood and serum samples will taken from RA patients
arm group label: Rheumatoid arthritis patients
Blood and serum samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Fatma Meligy, Dr
role: Principal Investigator
affiliation: FYMeligy
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
citation: Alpizar-Rodriguez D, Finckh A. Environmental factors and hormones in the development of rheumatoid arthritis. Semin Immunopathol. 2017 Jun;39(4):461-468. doi: 10.1007/s00281-017-0624-2. Epub 2017 Apr 27.
PMID: 28451785
citation: Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461. Erratum In: Ann Rheum Dis. 2010 Oct;69(10):1892.
PMID: 20699241
citation: Yan F, Li H, Zhong Z, Zhou M, Lin Y, Tang C, Li C. Co-Delivery of Prednisolone and Curcumin in Human Serum Albumin Nanoparticles for Effective Treatment of Rheumatoid Arthritis. Int J Nanomedicine. 2019 Nov 22;14:9113-9125. doi: 10.2147/IJN.S219413. eCollection 2019.
PMID: 31819422
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Fatma Yassine Meligy
investigator title: Princible investigator
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No
ipd description: study the relation between RDW and level of serum albumin in RA patients and association with the disease activity and severity.