<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT138901292641N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-04-18</date_registration>
      <primary_sponsor>Tehran University Of Medical Sciences</primary_sponsor>
      <public_title>Etanercept Versus Placebo in Ocular Manifestations of Behcet's Disease, a single Blind Controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>Etanercept Versus Placebo in Ocular Manifestations of Behcet's Disease, a single Blind Controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2454</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>4</phase>
      <hc_freetext>Ocular involvement in Behcet's disease.</hc_freetext>
      <i_freetext>Intervention 1: Etanercept 50 mg weekly for one year as well as Methotrexate as 15 mg weekly during the one year plus prednisolone as 30 mg daily, at the entry to the study. The dose will be adjusted and tapered if frank improvement or remission occurs. Intervention 2: Methotrexate as 15 mg weekly during the one year plus prednisolone as 30 mg daily, at the entry to the study. The dose will be adjusted and tapered if frank improvement or remission occurs.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahar Sadeghi MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8802 6956</telephone>
        <email>bahar@bahars.net</email>
        <affiliation>Researcher-General Physician</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Prof. Fereydoun Davatchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8802 6956</telephone>
        <email>fddh@neda.net</email>
        <affiliation>Rheumatology Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Behcet's Disease according to the International Criteria for Behcet's disease (ICBD), Active posterior uveitis and/or retinal vasculitis &#13;
Exclusion Criteria: Visual acuity inferior to 1/10 on Snellen chart, Being under cytotoxic drugs or having received them in the past 2 months, Not being able to follow the one year treatment and the regular follow ups</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M35.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>behcet's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Etanercept 50 mg weekly for one year as well as Methotrexate as 15 mg weekly during the one year plus prednisolone as 30 mg daily, at the entry to the study. The dose will be adjusted and tapered if frank improvement or remission occurs</i_keyword>
      <i_keyword>Methotrexate as 15 mg weekly during the one year plus prednisolone as 30 mg daily, at the entry to the study. The dose will be adjusted and tapered if frank improvement or remission occurs</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Inflammatory Activity Index. Timepoint: 2 months. Method of measurement: Total Inflammatory Activity Index.</prim_outcome>
      <prim_outcome>Visual acuity. Timepoint: 2 months. Method of measurement: Total Inflammatory Activity Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total Inflammatory Activity Index (TIAI). Timepoint: 2 months. Method of measurement: ophtalmologist's record.</sec_outcome>
      <sec_outcome>Visual acuity. Timepoint: 2 months. Method of measurement: ophtalmologist's record.</sec_outcome>
      <sec_outcome>Disease activity index for anterior uveitis. Timepoint: 2 months. Method of measurement: ophtalmologist's record.</sec_outcome>
      <sec_outcome>Retinal vasculitis. Timepoint: 2 months. Method of measurement: ophtalmologist's record,Top con TR angiography 50S, skiascopy,ocular coherenttomography.</sec_outcome>
      <sec_outcome>Total Adjusted Disease Activity Index (TADAI). Timepoint: 2 months. Method of measurement: ophtalmologist's record.</sec_outcome>
      <sec_outcome>Disease activity index for posterior uveitis. Timepoint: 2 months. Method of measurement: ophtalmologist's record.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>NCT00931957 </sec_id>
        <issuing_authority>clinicaltrials.gov</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-02-16</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>6th floor-central university department-Ghods street-Keshavarz Avenue Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
