<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/NCT03763201</url>
  </required_header>
  <id_info>
    <org_study_id>BenhaU 112018</org_study_id>
    <nct_id>NCT03763201</nct_id>
  </id_info>
  <brief_title>Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in Rheumatoid Arthritis</brief_title>
  <acronym>GITR</acronym>
  <official_title>Role of Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) as a Marker of Activity in Rheumatoid Arthritis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benha University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aimed to measure serum and synovial fluid (SF) levels of GITR in patients with&#xD;
      recent onset RA before and after initiation of therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Technical design:&#xD;
&#xD;
           Study design: a longitudinal observational cohort study.&#xD;
&#xD;
           This study will be carried out on two groups:&#xD;
&#xD;
             -  Group (I): fifty early onset rheumatoid arthritis (RA) patients fulfilled the 2010&#xD;
                American college of rheumatology (ACR) - European league against rheumatism (EULAR)&#xD;
                classification criteria for RA [11].&#xD;
&#xD;
             -  Group (II): Twenty healthy individuals of matching age and sex as control group.&#xD;
&#xD;
           Both groups will be recruited from the in-patients and out-patients' clinic of the&#xD;
           Rheumatology, Rehabilitation&amp; Physical Medicine Department, Benha University Hospital.&#xD;
&#xD;
           All patients will be evaluated at baseline at 6 months follow up using:&#xD;
&#xD;
           (A) Clinical evaluation 1. Complete history taking. 2. Thorough clinical examination. 3.&#xD;
           Disease activity using DAS28 [12]&#xD;
&#xD;
           (B) Laboratory assessment:&#xD;
&#xD;
           All patients will be subjected to the following measurements:&#xD;
&#xD;
             1. Erythrocyte sedimentation rate (ESR).&#xD;
&#xD;
             2. C reactive protein (CRP).&#xD;
&#xD;
             3. Rheumatoid factor (RF)&#xD;
&#xD;
             4. Anti-cyclic citrullinated peptide (Anti- CCP).&#xD;
&#xD;
             5. glucocorticoid-induced tumour necrosis factor receptor related protein (GITR)&#xD;
&#xD;
           (D) Musculoskeletal ultrasound assessment: Ultrasound examinations will be performed for&#xD;
           patients and control groups using a Logiq e equipped with a broadband 8- to 13-MHz&#xD;
           linear transducer&#xD;
&#xD;
        2. Statistical analysis The collected data will be tabulated and analyzed using suitable&#xD;
           statistical computer version.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 8, 2018</start_date>
  <completion_date type="Anticipated">September 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>28 tender joints count</measure>
    <time_frame>4 months</time_frame>
    <description>tender joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>28 swollen joints count</measure>
    <time_frame>4 months</time_frame>
    <description>swollen joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>patient's global assessment of disease activity</measure>
    <time_frame>4 months</time_frame>
    <description>patient's global assessment of disease activity on 0 to 100 mm VAS 0 is the best and 100 is the worst.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>disease activity score of 28 joint count (DAS28)</measure>
    <time_frame>4 months</time_frame>
    <description>DAS28 is calculated from tender and swollen joint counts , ESR and patient's global assessment of disease activity according to the following formula DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * global patient assesment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>erythrocyte sedimentation rate (ESR)</measure>
    <time_frame>4 months</time_frame>
    <description>ESR measured in mm/1st hour by westergren method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C reactive protein (CRP)</measure>
    <time_frame>4 months</time_frame>
    <description>CRP measured in mg/L using nephlometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>grey scale12 joint score</measure>
    <time_frame>4 months</time_frame>
    <description>grey scale musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following greyscale synovitis semiquantitative grades were assumed: Grade 0: absent. Grade 1: mild with anechoic / hypoechoic line below the capsule of the joint. Grade 2: moderate with elevation of the joint capsule that becomes parallel to the area of the joint. Grade 3: severe with marked distension of the capsule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>power Doppler 12 joint score</measure>
    <time_frame>4 months</time_frame>
    <description>power Doppler musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following power Doppler synovitis grades were assumed: Grade 0: no colour signal inside joint area. Grade 1: up to 3 colour signals inside joint area. Grade 2: colour signals less than half of joint area and more than grade 1. Grade 3: colour signals more than half of joint area.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rheumatoid factor</measure>
    <time_frame>4 months</time_frame>
    <description>rheumatoid factor measured in U/ml using latex agglutination test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>anticyclic citrullinated antibody (Anti CCP)</measure>
    <time_frame>4 months</time_frame>
    <description>Anti CCP measured in Unit/ml using ELISA</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>rheumatoid arthritis</arm_group_label>
    <description>recently diagnosed rheumatoid arthritis patients in whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum and synovial fluid (if clinically determined knee effusion)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>age and sex matched healthy volunteers whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>measurement of GITR</intervention_name>
    <description>serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>rheumatoid arthritis</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum and synovial fluid samples from RA patients&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        2 groups: first: recently diagnosed RA patients 2nd : healthy control ( age and sex&#xD;
        matched)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infection malignancy receiving treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Waleed A Hassan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Benha university- Qaluibya- Egypt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Waleed A Hassan, MD</last_name>
    <phone>02 01095000886</phone>
    <email>waleed22101979@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eman G Behiry, MD</last_name>
    <phone>00201006216116</phone>
    <email>FATEMAHAGGAG@GMAIL.COM</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>bENHA UNIVERSITY HOSPITAL</name>
      <address>
        <city>Banhā</city>
        <state>Qalubiya</state>
        <zip>13518</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali Fouda, MD</last_name>
      <phone>00201066640220</phone>
      <email>ali71960@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Waleed A Hassan, MD</last_name>
      <phone>00201095000886</phone>
      <email>waleed22101979@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>July 5, 2020</last_update_submitted>
  <last_update_submitted_qc>July 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Waleed Ahmed Salaheldeen Hassan</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>glucocorticoid-induced tumour necrosis factor receptor related protein</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>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03763201
org study id: BenhaU 112018
nct id: NCT03763201
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aimed to measure serum and synovial fluid (SF) levels of GITR in patients with
      recent onset RA before and after initiation of therapy
1. Technical design:

           Study design: a longitudinal observational cohort study.

           This study will be carried out on two groups:

             -  Group (I): fifty early onset rheumatoid arthritis (RA) patients fulfilled the 2010
                American college of rheumatology (ACR) - European league against rheumatism (EULAR)
                classification criteria for RA [11].

             -  Group (II): Twenty healthy individuals of matching age and sex as control group.

           Both groups will be recruited from the in-patients and out-patients' clinic of the
           Rheumatology, Rehabilitation& Physical Medicine Department, Benha University Hospital.

           All patients will be evaluated at baseline at 6 months follow up using:

           (A) Clinical evaluation 1. Complete history taking. 2. Thorough clinical examination. 3.
           Disease activity using DAS28 [12]

           (B) Laboratory assessment:

           All patients will be subjected to the following measurements:

             1. Erythrocyte sedimentation rate (ESR).

             2. C reactive protein (CRP).

             3. Rheumatoid factor (RF)

             4. Anti-cyclic citrullinated peptide (Anti- CCP).

             5. glucocorticoid-induced tumour necrosis factor receptor related protein (GITR)

           (D) Musculoskeletal ultrasound assessment: Ultrasound examinations will be performed for
           patients and control groups using a Logiq e equipped with a broadband 8- to 13-MHz
           linear transducer

        2. Statistical analysis The collected data will be tabulated and analyzed using suitable
           statistical computer version.
observational model: Cohort
time perspective: Prospective
measure: 28 tender joints count
time frame: 4 months
description: tender joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
measure: 28 swollen joints count
time frame: 4 months
description: swollen joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
measure: patient's global assessment of disease activity
time frame: 4 months
description: patient's global assessment of disease activity on 0 to 100 mm VAS 0 is the best and 100 is the worst.
measure: disease activity score of 28 joint count (DAS28)
time frame: 4 months
description: DAS28 is calculated from tender and swollen joint counts , ESR and patient's global assessment of disease activity according to the following formula DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * global patient assesment
measure: erythrocyte sedimentation rate (ESR)
time frame: 4 months
description: ESR measured in mm/1st hour by westergren method
measure: C reactive protein (CRP)
time frame: 4 months
description: CRP measured in mg/L using nephlometry
measure: grey scale12 joint score
time frame: 4 months
description: grey scale musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following greyscale synovitis semiquantitative grades were assumed: Grade 0: absent. Grade 1: mild with anechoic / hypoechoic line below the capsule of the joint. Grade 2: moderate with elevation of the joint capsule that becomes parallel to the area of the joint. Grade 3: severe with marked distension of the capsule.
measure: power Doppler 12 joint score
time frame: 4 months
description: power Doppler musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following power Doppler synovitis grades were assumed: Grade 0: no colour signal inside joint area. Grade 1: up to 3 colour signals inside joint area. Grade 2: colour signals less than half of joint area and more than grade 1. Grade 3: colour signals more than half of joint area.
measure: rheumatoid factor
time frame: 4 months
description: rheumatoid factor measured in U/ml using latex agglutination test
measure: anticyclic citrullinated antibody (Anti CCP)
time frame: 4 months
description: Anti CCP measured in Unit/ml using ELISA
arm group label: rheumatoid arthritis
description: recently diagnosed rheumatoid arthritis patients in whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum and synovial fluid (if clinically determined knee effusion)
arm group label: control group
description: age and sex matched healthy volunteers whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum.
intervention type: Diagnostic Test
intervention name: measurement of GITR
description: serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein
arm group label: control group
arm group label: rheumatoid arthritis
serum and synovial fluid samples from RA patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Waleed A Hassan, MD
role: Principal Investigator
affiliation: Benha university- Qaluibya- Egypt
last name: Waleed A Hassan, MD
phone: 02 01095000886
email: waleed22101979@yahoo.com
last name: Eman G Behiry, MD
phone: 00201006216116
email: FATEMAHAGGAG@GMAIL.COM
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Waleed Ahmed Salaheldeen Hassan
investigator title: Assistant professor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Necrosis
sharing ipd: Undecided