<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/NCT03770923</url>
  </required_header>
  <id_info>
    <org_study_id>Rheumatoid Arithritis</org_study_id>
    <nct_id>NCT03770923</nct_id>
  </id_info>
  <brief_title>Effect of Some Drugs on Rheumatoid Arithritis Activity</brief_title>
  <official_title>Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sherief Abd-Elsalam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta 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>
      Effect of Some Drugs on Rheumatoid Arithritis Activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">October 2027</completion_date>
  <primary_completion_date type="Anticipated">October 2026</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>se level of IL-17</measure>
    <time_frame>6 months</time_frame>
    <description>change in level of IL-17</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rupatadine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rupatadine 10 mg once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Montelukast</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Montelukast 10 mg daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rupatadine</intervention_name>
    <description>Rupatadine 10 mg daily</description>
    <arm_group_label>Rupatadine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Montelukast</intervention_name>
    <description>Montelukast 10 mg daily</description>
    <arm_group_label>Montelukast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  liver or renal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sahar k Hegazy, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Clinical Pharmacy Department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tarek M Mostafa, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Clinical pharmacy Department- Tanta University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Salwa E Abd El-Ghany, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Rheumatology Dept. - Tanta University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fedaa AK Kotkata, Msc</last_name>
    <role>Study Chair</role>
    <affiliation>Clinical pharmacy Department-Tanta University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherief Abd-Elsalam, Ph D</last_name>
    <phone>00201147773440</phone>
    <email>sheriefabdelsalam@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sherief Abd-Elsalam</name>
      <address>
        <city>Tanta</city>
        <zip>35111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fedaa Kotkata, Msc</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Sherief Abd-Elsalam</investigator_full_name>
    <investigator_title>Ass. Prof. Tropical Medicine</investigator_title>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Montelukast</mesh_term>
  </intervention_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/NCT03770923
org study id: Rheumatoid Arithritis
nct id: NCT03770923
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Effect of Some Drugs on Rheumatoid Arithritis Activity.
The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: se level of IL-17
time frame: 6 months
description: change in level of IL-17
arm group label: No intervention
arm group type: No Intervention
description: No intervention
arm group label: Rupatadine
arm group type: Active Comparator
description: Rupatadine 10 mg once daily.
arm group label: Montelukast
arm group type: Active Comparator
description: Montelukast 10 mg daily
intervention type: Drug
intervention name: Rupatadine
description: Rupatadine 10 mg daily
arm group label: Rupatadine
intervention type: Drug
intervention name: Montelukast
description: Montelukast 10 mg daily
arm group label: Montelukast
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sahar k Hegazy, Prof
role: Principal Investigator
affiliation: Head of Clinical Pharmacy Department
last name: Tarek M Mostafa, Prof
role: Study Director
affiliation: Clinical pharmacy Department- Tanta University
last name: Salwa E Abd El-Ghany, Prof
role: Study Chair
affiliation: Rheumatology Dept. - Tanta University
last name: Fedaa AK Kotkata, Msc
role: Study Chair
affiliation: Clinical pharmacy Department-Tanta University
last name: Sherief Abd-Elsalam, Ph D
phone: 00201147773440
email: sheriefabdelsalam@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Tanta University
investigator full name: Sherief Abd-Elsalam
investigator title: Ass. Prof. Tropical Medicine
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Montelukast
sharing ipd: Undecided