<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/NCT04464642</url>
  </required_header>
  <id_info>
    <org_study_id>BSMMU /2019/5499</org_study_id>
    <nct_id>NCT04464642</nct_id>
  </id_info>
  <brief_title>Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis</brief_title>
  <official_title>Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Mohammad Mamun Khan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is a randomized controlled study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomization controlled study on Rheumatoid arthritis patients whos disease activity is&#xD;
      high, controlled subjects will be given methotrexate and study subjects will get tofacitinib&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 10, 2019</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</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>
    <intervention_model_description>open label Randomization controlled clinical study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DAS-28 CRP at 6 month</measure>
    <time_frame>6 months</time_frame>
    <description>disease activity score in 28 joints has to measured at 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SDAI at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>simplified disease activity index at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAQ-DI at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>health assesment by HAQ-DI at 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group &quot;A&quot; is a control arm who will get conventional drug (methotrexate). 25 mg subcutaneous weekly . at 3 months if DAS-28 not fall by at least 1.2, drug is to be changed and regarded as therapy failure. if at least 1.2 improvement of DAS-28 occur,then therapy is continued for 6 monyhs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group &quot;B&quot; will get tofacitinib 10 mg weekly. if DAS-28 not improved at least 1.2 at 3 months, it is regarded as therapy failure. if improved at least 1.2, then therapy continued for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Methotrexate 25 mg subcutaneous is given in group A</description>
    <arm_group_label>group A</arm_group_label>
    <other_name>injection trexonate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tofacitinib</intervention_name>
    <description>tofacitinib 10 mg given in group B</description>
    <arm_group_label>group B</arm_group_label>
    <other_name>tofacit</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:1. age greater than 18 years 2. patients fulfill the ACR-EULAR&#xD;
        classification criteria for RA 3.DAS-28 CRP more than 5.1&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. systemic infection&#xD;
&#xD;
          2. hemoglobin less than 9 mg/dl&#xD;
&#xD;
          3. WBC &lt;4000, neutrophil &lt;1000, platelet &lt;100000/mm&#xD;
&#xD;
          4. live vaccine within 3 months&#xD;
&#xD;
          5. GFR &lt; 50 ml/min&#xD;
&#xD;
          6. ALT &gt; 2 times ULN&#xD;
&#xD;
          7. pregnancy&#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>Mohammad M Khan, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Resident doctor, BSMMU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bangabandhu Seikh Mujib Medical University</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</investigator_affiliation>
    <investigator_full_name>Dr. Mohammad Mamun Khan</investigator_full_name>
    <investigator_title>Resident, BSMMU</investigator_title>
  </responsible_party>
  <keyword>rheumatoid arthritis tofacitinib methotrexate</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>Methotrexate</mesh_term>
    <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/NCT04464642
org study id: BSMMU /2019/5499
nct id: NCT04464642
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It is a randomized controlled study
Randomization controlled study on Rheumatoid arthritis patients whos disease activity is
      high, controlled subjects will be given methotrexate and study subjects will get tofacitinib
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: open label Randomization controlled clinical study
primary purpose: Treatment
masking: None (Open Label)
measure: DAS-28 CRP at 6 month
time frame: 6 months
description: disease activity score in 28 joints has to measured at 6 months
measure: SDAI at 6 months
time frame: 6 months
description: simplified disease activity index at 6 months
measure: HAQ-DI at 6 months
time frame: 6 months
description: health assesment by HAQ-DI at 6 months
arm group label: group A
arm group type: Experimental
description: group "A" is a control arm who will get conventional drug (methotrexate). 25 mg subcutaneous weekly . at 3 months if DAS-28 not fall by at least 1.2, drug is to be changed and regarded as therapy failure. if at least 1.2 improvement of DAS-28 occur,then therapy is continued for 6 monyhs
arm group label: group B
arm group type: Experimental
description: group "B" will get tofacitinib 10 mg weekly. if DAS-28 not improved at least 1.2 at 3 months, it is regarded as therapy failure. if improved at least 1.2, then therapy continued for 6 months
intervention type: Drug
intervention name: Methotrexate
description: Methotrexate 25 mg subcutaneous is given in group A
arm group label: group A
other name: injection trexonate
intervention type: Drug
intervention name: Tofacitinib
description: tofacitinib 10 mg given in group B
arm group label: group B
other name: tofacit
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohammad M Khan, MBBS
role: Principal Investigator
affiliation: Resident doctor, BSMMU
facility: 
country: Bangladesh
responsible party type: Sponsor-Investigator
investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
investigator full name: Dr. Mohammad Mamun Khan
investigator title: Resident, BSMMU
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Methotrexate
mesh term: Tofacitinib
sharing ipd: No