<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/NCT03011281</url>
  </required_header>
  <id_info>
    <org_study_id>HUHRD-SPE-16-09</org_study_id>
    <nct_id>NCT03011281</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis</brief_title>
  <official_title>Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanyang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanyang University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this single center, prospective, non-interventional inception cohort is to&#xD;
      understand patient characteristics, general treatment patterns, effectiveness, and safety of&#xD;
      Tofacitinib for rheumatoid arthritis patients in the real-world setting.&#xD;
&#xD;
        1. To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib&#xD;
&#xD;
        2. To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean&#xD;
           RA patients.&#xD;
&#xD;
        3. To further evaluate safety, effectiveness and demographic characteristics of the&#xD;
           patients treated with Tofacitinib matched with and compared to biologic DMARDs from the&#xD;
           BIOPSY registry database.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 &lt; 2.6) rate (%)</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of safety based on adverse events that occur during 5 years of patient monitoring.</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of adherence with Patient-reported Adherence, and Medication Possession Ratio (MPR) at 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 weeks of clinical visit.</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Health assessment using Visual Analogue Scale (VAS)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of sleep disturbance using Visual Analogue Scale (VAS)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy with Simple Disease Activity Index (SDAI)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy with Clinical Disease Activity Index (CDAI)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">378</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>RA patients who start Tofacitinib</arm_group_label>
    <description>Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tofacitinib</intervention_name>
    <arm_group_label>RA patients who start Tofacitinib</arm_group_label>
    <other_name>Xeljanz</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Hemoglobin Hematocrit WBC Platelet count ESR CRP ALT AST ALP BUN Creatinine Bilirubin&#xD;
      Urinalysis Total Cholesterol HDL (Calculated) LDL TG Rheumatoid factor(RF) Anti-nuclear&#xD;
      antibodies(ANA) Anti-CCP HbA1c&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Korean RA patients who start Tofacitinib with moderately to severely active RA who have had&#xD;
        an inadequate response or intolerance to methotrexate or biologics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A. Patients who provide a written informed consent form of participating in this study.&#xD;
&#xD;
        B. Patients who are more than 19 years old. C. Patients with moderately to severely active&#xD;
        rheumatoid arthritis as defined per EULAR guidelines, who have had an inadequate response&#xD;
        or are intolerant to methotrexate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A. Patients who do not provide a written informed consent form of participating in this&#xD;
        study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yoon-Kyoung Sung, MD, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hanyang University Hospital for Rheumatic Diseases</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yoon-Kyoung Sung, MD, PhD, MPH</last_name>
    <phone>82-2-2290-9250</phone>
    <email>sungyk@hanyang.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hanyang University</name>
      <address>
        <city>Seoul</city>
        <zip>04763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yoon-kyoung Sung, MD, PhD, MPH</last_name>
      <phone>82-2-2290-9250</phone>
      <email>sungyk@hanyang.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hanyang University</investigator_affiliation>
    <investigator_full_name>Yoon-Kyoung Sung</investigator_full_name>
    <investigator_title>Associate professor</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>Tofacitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03011281
org study id: HUHRD-SPE-16-09
nct id: NCT03011281
lead sponsor: 
has dmc: No
The objectives of this single center, prospective, non-interventional inception cohort is to
      understand patient characteristics, general treatment patterns, effectiveness, and safety of
      Tofacitinib for rheumatoid arthritis patients in the real-world setting.

        1. To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib

        2. To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean
           RA patients.

        3. To further evaluate safety, effectiveness and demographic characteristics of the
           patients treated with Tofacitinib matched with and compared to biologic DMARDs from the
           BIOPSY registry database.
observational model: Cohort
time perspective: Prospective
measure: DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)
time frame: 5 years
measure: Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))
time frame: 5 years
measure: Assessment of safety based on adverse events that occur during 5 years of patient monitoring.
time frame: 5 years
measure: Assessment of adherence with Patient-reported Adherence, and Medication Possession Ratio (MPR) at 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 weeks of clinical visit.
time frame: 5 years
measure: Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)
time frame: 5 years
measure: Global Health assessment using Visual Analogue Scale (VAS)
time frame: 5 years
measure: Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)
time frame: 5 years
measure: Assessment of sleep disturbance using Visual Analogue Scale (VAS)
time frame: 5 years
measure: Assessment of efficacy with Simple Disease Activity Index (SDAI)
time frame: 5 years
measure: Assessment of efficacy with Clinical Disease Activity Index (CDAI)
time frame: 5 years
measure: Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria
time frame: 5 years
measure: Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)
time frame: 5 years
arm group label: RA patients who start Tofacitinib
description: Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics.
intervention type: Drug
intervention name: Tofacitinib
arm group label: RA patients who start Tofacitinib
other name: Xeljanz
Hemoglobin Hematocrit WBC Platelet count ESR CRP ALT AST ALP BUN Creatinine Bilirubin
      Urinalysis Total Cholesterol HDL (Calculated) LDL TG Rheumatoid factor(RF) Anti-nuclear
      antibodies(ANA) Anti-CCP HbA1c
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Yoon-Kyoung Sung, MD, PhD, MPH
role: Principal Investigator
affiliation: Hanyang University Hospital for Rheumatic Diseases
last name: Yoon-Kyoung Sung, MD, PhD, MPH
phone: 82-2-2290-9250
email: sungyk@hanyang.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Hanyang University
investigator full name: Yoon-Kyoung Sung
investigator title: Associate professor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Tofacitinib
sharing ipd: No