<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/NCT03770702</url>
  </required_header>
  <id_info>
    <org_study_id>Rheumatoid</org_study_id>
    <nct_id>NCT03770702</nct_id>
  </id_info>
  <brief_title>Statins and ARBs on Rheumatoid Activity</brief_title>
  <official_title>Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients</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>
      Investigational and comparative study between the anti-inflammatory effectof both angiotensin&#xD;
      reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims at ivestigating and comparing the anti-inflammatory effectof both angiotensin&#xD;
      reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2025</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>Change in disease activity score</measure>
    <time_frame>6 months</time_frame>
    <description>DAS28-ESR</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angiotensin receptor blockers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ARB ( Angiotensin receptor blockers) + Traditional therpy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Statins</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Statin + Traditional therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Angiotensin receptor blockers</intervention_name>
    <description>Candesartan</description>
    <arm_group_label>Angiotensin receptor blockers</arm_group_label>
    <other_name>Cansartan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Statins</intervention_name>
    <description>Atorvastatin</description>
    <arm_group_label>Statins</arm_group_label>
    <other_name>Ator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Hepatic or renal impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</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>Prof of Clinical Pharmacy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emad M Elshebini, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Rheumatology Dept. - Menoufia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed HM El-Abd, 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>Ahmed El-Abd, 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>Angiotensin Receptor Antagonists</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/NCT03770702
org study id: Rheumatoid
nct id: NCT03770702
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Investigational and comparative study between the anti-inflammatory effectof both angiotensin
      reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients
The study aims at ivestigating and comparing the anti-inflammatory effectof both angiotensin
      reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in disease activity score
time frame: 6 months
description: DAS28-ESR
arm group label: Control group
arm group type: No Intervention
description: No intervention
arm group label: Angiotensin receptor blockers
arm group type: Active Comparator
description: ARB ( Angiotensin receptor blockers) + Traditional therpy.
arm group label: Statins
arm group type: Active Comparator
description: Statin + Traditional therapy.
intervention type: Drug
intervention name: Angiotensin receptor blockers
description: Candesartan
arm group label: Angiotensin receptor blockers
other name: Cansartan
intervention type: Drug
intervention name: Statins
description: Atorvastatin
arm group label: Statins
other name: Ator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
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: Prof of Clinical Pharmacy
last name: Emad M Elshebini, MD
role: Study Chair
affiliation: Rheumatology Dept. - Menoufia University
last name: Ahmed HM El-Abd, 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: Angiotensin Receptor Antagonists
sharing ipd: Undecided