<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/NCT02982083</url>
  </required_header>
  <id_info>
    <org_study_id>931755</org_study_id>
    <nct_id>NCT02982083</nct_id>
  </id_info>
  <brief_title>Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis</brief_title>
  <official_title>Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sara Saeidi Shahri</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mashhad University of Medical Sciences</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators select 40 postmenopausal women suffering from RA with 2.5&lt;DAS28&lt;5.5&#xD;
      referring to rheumatology clinics of Mashhad university of medical sciences and randomly&#xD;
      divide them into intervention group and placebo group. Evista tab 60mg/day and placebo are&#xD;
      administered double blind. In the beginning, total bone mineral density (BMD) assessment is&#xD;
      carried out from all patients and then Alendronate is discontinued in 2 groups. In first 3&#xD;
      months, in addition to Evista and placebo, MTX tab 2.5mg is given to patients and they are&#xD;
      allowed to consume NSAID with accurate record of its dosage. Patients visit rheumatologist&#xD;
      monthly in these 3 months and NSAID should be discontinued 48 hours before every visit. At&#xD;
      the end of month 3, disease activity and probable complications are evaluated and compared in&#xD;
      2 groups. Classic regimen should be started for every patient who doesn't enter remission&#xD;
      phase in first 3 months.&#xD;
&#xD;
      In 4th month, DMARD regimen is administered and then patients are visited every 2 months.&#xD;
      Clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. After 12 months, another&#xD;
      total BMD test is carried out and then data are analyzed including changes in BMD, DAS28,&#xD;
      EULAR response criteria and HAQ-DI score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">September 2020</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>N/A</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of DAS-28 criteria</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessing of complications</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>DAS-28 criteria</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EULAR criteria</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAQ-DI criteria</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing of Bone Marrow Density score</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Evista</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Raloxifene hydrochloride</intervention_name>
    <description>20 patients consume raloxifene hydrochloride oral tablet daily for one year.</description>
    <arm_group_label>Evista</arm_group_label>
    <other_name>Evista</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>20 patients consume placebo oral tablets daily for one year.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are postmenopausal women.&#xD;
&#xD;
          -  Patients should fit at least 4 criteria of ACR-1987 criteria for rheumatoid arthritis.&#xD;
&#xD;
          -  Patients should be in range of 2.5 &lt;DAS28-ESR &lt;5.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of thrombotic events&#xD;
&#xD;
          -  Patients suffering from another rheumatic diseases simultaneously&#xD;
&#xD;
          -  Patients with sever symptoms of menopause&#xD;
&#xD;
          -  Patients with known psychological diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maryam Sahebari, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Mashhad University of Medical Sciences</affiliation>
  </overall_official>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 1, 2021</last_update_submitted>
  <last_update_submitted_qc>December 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mashhad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Sara Saeidi Shahri</investigator_full_name>
    <investigator_title>Medical Student</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>Raloxifene</keyword>
  <keyword>Disease activity</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Raloxifene Hydrochloride</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02982083
org study id: 931755
nct id: NCT02982083
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators select 40 postmenopausal women suffering from RA with 2.5<DAS28<5.5
      referring to rheumatology clinics of Mashhad university of medical sciences and randomly
      divide them into intervention group and placebo group. Evista tab 60mg/day and placebo are
      administered double blind. In the beginning, total bone mineral density (BMD) assessment is
      carried out from all patients and then Alendronate is discontinued in 2 groups. In first 3
      months, in addition to Evista and placebo, MTX tab 2.5mg is given to patients and they are
      allowed to consume NSAID with accurate record of its dosage. Patients visit rheumatologist
      monthly in these 3 months and NSAID should be discontinued 48 hours before every visit. At
      the end of month 3, disease activity and probable complications are evaluated and compared in
      2 groups. Classic regimen should be started for every patient who doesn't enter remission
      phase in first 3 months.

      In 4th month, DMARD regimen is administered and then patients are visited every 2 months.
      Clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. After 12 months, another
      total BMD test is carried out and then data are analyzed including changes in BMD, DAS28,
      EULAR response criteria and HAQ-DI score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Evaluation of DAS-28 criteria
time frame: 3 months
measure: Assessing of complications
time frame: 3 months
measure: DAS-28 criteria
time frame: 12 months
measure: Complications
time frame: 12 months
measure: EULAR criteria
time frame: 12 months
measure: HAQ-DI criteria
time frame: 12 months
measure: Assessing of Bone Marrow Density score
time frame: 12 months
arm group label: Evista
arm group type: Active Comparator
description: 20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.
arm group label: Placebo
arm group type: Placebo Comparator
description: 20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year.
intervention type: Drug
intervention name: Raloxifene hydrochloride
description: 20 patients consume raloxifene hydrochloride oral tablet daily for one year.
arm group label: Evista
other name: Evista
intervention type: Drug
intervention name: Placebo Oral Tablet
description: 20 patients consume placebo oral tablets daily for one year.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Maryam Sahebari, Professor
role: Study Director
affiliation: Mashhad University of Medical Sciences
responsible party type: Sponsor-Investigator
investigator affiliation: Mashhad University of Medical Sciences
investigator full name: Sara Saeidi Shahri
investigator title: Medical Student
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Raloxifene Hydrochloride