<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/NCT02248792</url>
  </required_header>
  <id_info>
    <org_study_id>NMCHDer</org_study_id>
    <nct_id>NCT02248792</nct_id>
  </id_info>
  <brief_title>Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.</brief_title>
  <official_title>Improvement in the Quality of Life of Patients With Severe Plaque Psoriasis Treated With Systemic Methotrexate in Fixed Doses of 10mg or 25mg Orally Once Weekly: a Prospective, Randomized, Double-blind, Parallel Group Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Narayana Medical College &amp; Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Narayana Medical College &amp; Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe&#xD;
      psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis,&#xD;
      more so if disease is severe.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2013</start_date>
  <primary_completion_date type="Anticipated">January 2015</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in health related quality of life</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>comparison of improvement in health related quality of life between Group A and Group B</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Severe Plaque Type Psoriasis</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Methotrexate 10mg orally once weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Methotrexate 25mg orally once weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age range 18 to 65 years Both sexes Severe plaque-type psoriasis (BSA &gt;10% or PASI &gt;12) -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnancy Lactation Malignancy or immunosuppression including HIV Liver disease Renal&#xD;
        disease Non compliant Psychiatric illness Hypersensitivity to methotrexate in the past&#xD;
&#xD;
        -&#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>C V Krishna, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Narayana Medical college and hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>C V Krishna, MD</last_name>
    <phone>+91-0413-2655961</phone>
    <email>vijay_postgradmed@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Narayana Med College and Hospital</name>
      <address>
        <city>Nellore</city>
        <state>AP</state>
        <zip>524003</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Avisa Rao, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 22, 2014</last_update_submitted>
  <last_update_submitted_qc>September 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Narayana Medical College &amp; Hospital</investigator_affiliation>
    <investigator_full_name>C V Krishna</investigator_full_name>
    <investigator_title>C V Krishna</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methotrexate</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/NCT02248792
org study id: NMCHDer
nct id: NCT02248792
lead sponsor: 
has dmc: No
Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe
      psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis,
      more so if disease is severe.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Improvement in health related quality of life
time frame: 12 weeks
measure: comparison of improvement in health related quality of life between Group A and Group B
time frame: 12 weeks
arm group label: Group A
arm group type: Experimental
description: Methotrexate 10mg orally once weekly
arm group label: Group B
arm group type: Active Comparator
description: Methotrexate 25mg orally once weekly
intervention type: Drug
intervention name: Methotrexate
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: C V Krishna, MD
role: Principal Investigator
affiliation: Narayana Medical college and hospital
last name: C V Krishna, MD
phone: +91-0413-2655961
email: vijay_postgradmed@yahoo.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Narayana Medical College & Hospital
investigator full name: C V Krishna
investigator title: C V Krishna
mesh term: Psoriasis
mesh term: Methotrexate