<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/NCT02188654</url>
  </required_header>
  <id_info>
    <org_study_id>alexmed12671416</org_study_id>
    <nct_id>NCT02188654</nct_id>
  </id_info>
  <brief_title>Metformin in Psoriatic Arthritis</brief_title>
  <official_title>Metformin: A Valid Add-On Drug in the Treatment of Psoriatic Arthritis-Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alexandria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alexandria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psoriatic arthritis (PsA) is a systemic, inflammatory disease. The chronic inflammation in&#xD;
      PsA predisposes patients to the metabolic syndrome (MetS). MetS is associated with systemic&#xD;
      inflammation and proinflammatory cytokines. Clinical observations and experimental results&#xD;
      argue for an anti-inflammatory and immunosuppressant property of MET.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The chronic inflammatory nature of psoriasis and PsA predisposes patients to cardiovascular&#xD;
      diseases and metabolic syndrome (MetS). MetS is associated with systemic inflammation and&#xD;
      proinflammatory cytokines.Clinical observations and experimental results argue for an&#xD;
      anti-inflammatory and immunosuppressant property of MET.&#xD;
&#xD;
      A randomized placebo-controlled trial was conducted to evaluate the efficacy and safety of&#xD;
      metformin as add-on therapy to MTX compared to MTX after 24 weeks in patients with PsA.&#xD;
&#xD;
      The study randomized 56 patients with a diagnosis of PsA . Patients with a history of a&#xD;
      cardiovascular event and diabetics were excluded. Body mass index (BMI) and classic&#xD;
      cardiovascular risk factors were recorded. Blood samples were analysed for glucose, lipid&#xD;
      profile, ESR, hsCRP, proinflammatory cytokines; tumour necrosis factor alpha (TNF-alpha),&#xD;
      interleukin-6 (IL-6) and IL-17. The homeostasis model assessment model for insulin resistance&#xD;
      (HOMA-IR) was used. The patients were randomized in a 1:1 ratio to receive 500mg/day retarded&#xD;
      formulation of metformin (n=29) or placebo (n=29). Continuation of stable doses of MTX&#xD;
      (25mg/week), NSAIDs, and/or corticosteroids (prednisone &lt;10 mg/day) was permitted. Metformin&#xD;
      drug pause on the day of MTX was given. Folic acid supplementation was given to both groups.&#xD;
      The primary clinical endpoint was the ACR 20% (ACR20) response at 24 weeks. Secondary&#xD;
      endpoints included reduction in PASI score, Health Assessment Questionnaire- Disability Index&#xD;
      (HAQ-DI) and Psoriatic arthritis response criteria (PsARC) score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ACR20 response</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PASI score</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability Index (HAQ-DI)</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psoriatic arthritis response criteria (PsARC) score</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Psoriatic Arthritis</condition>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>500 mg metformin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>500 mg of placebo tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>500mg/day retarded formulation of metformin</description>
    <arm_group_label>Metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>500 mg/day of placebo tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Psoriatic arthritis patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other inflammatory conditions&#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>Anna Abou-Raya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alexandria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alexandria</name>
      <address>
        <city>Alexandria</city>
        <zip>00203</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Anna Abou-Raya</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>psoriatic arthritis</keyword>
  <keyword>inflammation</keyword>
  <keyword>metabolic syndrome</keyword>
  <keyword>metformin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</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/NCT02188654
org study id: alexmed12671416
nct id: NCT02188654
lead sponsor: 
has dmc: Yes
Psoriatic arthritis (PsA) is a systemic, inflammatory disease. The chronic inflammation in
      PsA predisposes patients to the metabolic syndrome (MetS). MetS is associated with systemic
      inflammation and proinflammatory cytokines. Clinical observations and experimental results
      argue for an anti-inflammatory and immunosuppressant property of MET.
The chronic inflammatory nature of psoriasis and PsA predisposes patients to cardiovascular
      diseases and metabolic syndrome (MetS). MetS is associated with systemic inflammation and
      proinflammatory cytokines.Clinical observations and experimental results argue for an
      anti-inflammatory and immunosuppressant property of MET.

      A randomized placebo-controlled trial was conducted to evaluate the efficacy and safety of
      metformin as add-on therapy to MTX compared to MTX after 24 weeks in patients with PsA.

      The study randomized 56 patients with a diagnosis of PsA . Patients with a history of a
      cardiovascular event and diabetics were excluded. Body mass index (BMI) and classic
      cardiovascular risk factors were recorded. Blood samples were analysed for glucose, lipid
      profile, ESR, hsCRP, proinflammatory cytokines; tumour necrosis factor alpha (TNF-alpha),
      interleukin-6 (IL-6) and IL-17. The homeostasis model assessment model for insulin resistance
      (HOMA-IR) was used. The patients were randomized in a 1:1 ratio to receive 500mg/day retarded
      formulation of metformin (n=29) or placebo (n=29). Continuation of stable doses of MTX
      (25mg/week), NSAIDs, and/or corticosteroids (prednisone <10 mg/day) was permitted. Metformin
      drug pause on the day of MTX was given. Folic acid supplementation was given to both groups.
      The primary clinical endpoint was the ACR 20% (ACR20) response at 24 weeks. Secondary
      endpoints included reduction in PASI score, Health Assessment Questionnaire- Disability Index
      (HAQ-DI) and Psoriatic arthritis response criteria (PsARC) score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: ACR20 response
time frame: 24 weeks
measure: PASI score
time frame: 24 weeks
measure: Health Assessment Questionnaire
time frame: 24 weeks
measure: Disability Index (HAQ-DI)
time frame: 24 weeks
measure: Psoriatic arthritis response criteria (PsARC) score
time frame: 24 weeks
arm group label: Metformin
arm group type: Experimental
description: 500 mg metformin
arm group label: Placebo
arm group type: Placebo Comparator
description: 500 mg of placebo tablets
intervention type: Drug
intervention name: Metformin
description: 500mg/day retarded formulation of metformin
arm group label: Metformin
intervention type: Drug
intervention name: Placebo
description: 500 mg/day of placebo tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna Abou-Raya, MD
role: Principal Investigator
affiliation: University of Alexandria
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: University of Alexandria
investigator full name: Anna Abou-Raya
investigator title: MD
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Metformin