<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/NCT02986139</url>
  </required_header>
  <id_info>
    <org_study_id>20140339</org_study_id>
    <nct_id>NCT02986139</nct_id>
  </id_info>
  <brief_title>Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Crossover Study to Assess the Injection Site Pain Associated With a Modified Etanercept Formulation in Adult Subjects With Either Rheumatoid Arthritis or Psoriatic Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective was to assess the injection site pain associated with the new&#xD;
      formulation of etanercept compared with commercial etanercept in adults with rheumatoid&#xD;
      arthritis (RA) or psoriatic arthritis (PsA) as measured by a visual analog scale (VAS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 3b, multicenter, randomized, double-blind, 2-period, 2-sequence crossover&#xD;
      study in adults with RA or PsA who are naive to etanercept. The study will evaluate injection&#xD;
      site pain associated with the commercial formulation of etanercept and the new formulation of&#xD;
      etanercept immediately after injection of each formulation.The study will consist of a&#xD;
      screening period of up to 14 days, a 2 week treatment period with a 30 day post treatment&#xD;
      safety follow-up. Each dose will follow the recommended label dosing for adults with RA and&#xD;
      PsA: 50 mg weekly (scheduled approximately 7 days apart).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2016</start_date>
  <completion_date type="Actual">October 9, 2017</completion_date>
  <primary_completion_date type="Actual">September 8, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Injection Site Pain</measure>
    <time_frame>Immediately following injection of each study drug on day 1 and day 8 of this crossover study</time_frame>
    <description>Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Injection Site Pain by Disease Indication</measure>
    <time_frame>Immediately following injection of each study drug on day 1 and day 8 of this crossover study</time_frame>
    <description>Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>From first dose of etanercept to 30 days after the last dose; 38 days.</time_frame>
    <description>The severity of each adverse event was graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Arthritis, Rheumatoid; Arthritis, Psoriatic</condition>
  <arm_group>
    <arm_group_label>Sequence AB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a single 50 mg subcutaneous (SC) dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 1 (Treatment A) followed by a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 8 (Treatment B).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence BA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 1 (Treatment B) followed by a single 50 mg SC dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 8 (Treatment A).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Commercial Formulation Etanercept</intervention_name>
    <description>Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the commercial formulation.</description>
    <arm_group_label>Sequence AB</arm_group_label>
    <arm_group_label>Sequence BA</arm_group_label>
    <other_name>Enbrel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>New Formulation Etanercept</intervention_name>
    <description>Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the new formulation.</description>
    <arm_group_label>Sequence AB</arm_group_label>
    <arm_group_label>Sequence BA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Subject has provided informed consent prior to initiation of any study specific&#xD;
             activities/procedures.&#xD;
&#xD;
          -  Male or female subject is 18 years of age or older at time of signing the informed&#xD;
             consent form.&#xD;
&#xD;
          -  Subject has a diagnosis of RA or PsA and indicated for treatment with etanercept per&#xD;
             the current label, based on investigator judgment.&#xD;
&#xD;
          -  Subject is naïve to etanercept.&#xD;
&#xD;
          -  Subject is able to self-inject etanercept.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Subject is diagnosed with Felty's syndrome.&#xD;
&#xD;
          -  Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced&#xD;
             psoriasis, or other skin conditions.&#xD;
&#xD;
          -  Subject has a history of clinically significant skin allergies&#xD;
&#xD;
          -  Subject has a history of alcoholic hepatitis, nonalcoholic steatohepatitis or&#xD;
             immunodeficiency syndromes.&#xD;
&#xD;
          -  Subject has any active infection for which anti-infectives were indicated within 4&#xD;
             weeks prior to screening.&#xD;
&#xD;
          -  Subject has had a serious infection, defined as requiring hospitalization or&#xD;
             intravenous anti-infectives within 8 weeks prior to first dose of investigational&#xD;
             product.&#xD;
&#xD;
          -  Subject had prosthetic joint infection within 5 years of screening or native joint&#xD;
             infection within 1 year of screening.&#xD;
&#xD;
          -  Subject has known alcohol addiction or dependency.&#xD;
&#xD;
          -  Subject has positive hepatitis B surface antigen, hepatitis B core antibody (confirmed&#xD;
             by hepatitis B virus deoxyribonucleic acid (DNA) test) or hepatitis C virus antibody&#xD;
             serology at screening, or a positive medical history for hepatitis B or C. (Subjects&#xD;
             with a history of hepatitis B vaccination without history of hepatitis B are allowed&#xD;
             to enroll).&#xD;
&#xD;
          -  Subject has any active malignancy, including evidence of cutaneous basal or squamous&#xD;
             cell carcinoma or melanoma.&#xD;
&#xD;
          -  Subject has known history of active tuberculosis.&#xD;
&#xD;
          -  Subject has used biologic disease modifying agent (DMARD) less than or equal to 3&#xD;
             months prior to screening.&#xD;
&#xD;
          -  If subject is receiving continuous treatment with acetaminophen, non-steroidal&#xD;
             anti-inflammatory drug or tramadol, hydrocodone, oxycodone, codeine, and/or&#xD;
             propoxyphene and the dose is within 4 hours before study visit and dose is not stable&#xD;
             for ≥ 2 weeks before first dose of investigational product&#xD;
&#xD;
          -  For subjects not on continuous analgesics, subject has taken the following within 4&#xD;
             hours before screening: acetaminophen, non-steroidal anti-inflammatory drugs,&#xD;
             hydrocodone, codeine, tramadol, propoxyphene, and/or oxycodone (unless in the form of&#xD;
             OxyContin). For subjects not on continuous analgesics, subject has taken OxyContin&#xD;
             within 24 hours before screening.&#xD;
&#xD;
          -  Subject has received live vaccines less than or equal to 4 weeks prior to first dose&#xD;
             of investigational product.&#xD;
&#xD;
          -  Subject has laboratory abnormalities during screening.&#xD;
&#xD;
          -  Estimated creatinine clearance less than 50 mL/min.&#xD;
&#xD;
          -  Subject has any other laboratory abnormality, which, in the opinion of the&#xD;
             investigator poses a safety risk, will prevent the subject from completing the study,&#xD;
             or will interfere with the interpretation of the study results.&#xD;
&#xD;
          -  Subject is currently receiving treatment in another investigational device or drug&#xD;
             study, or less than 30 days since ending treatment on another investigational device&#xD;
             or drug study(s).&#xD;
&#xD;
          -  Other investigational procedures while participating in this study.&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding, or planning to become pregnant or breastfeed&#xD;
             during treatment and/or within 4 weeks after the last dose of etanercept.&#xD;
&#xD;
          -  Women of child-bearing potential with a positive pregnancy test.&#xD;
&#xD;
          -  Women of child-bearing potential who are unwilling to practice true sexual abstinence&#xD;
             or unwilling to use 1 of the following effective birth control methods during&#xD;
             treatment and for an additional 4 weeks after the last dose of etanercept.&#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>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sherman Oaks</city>
        <state>California</state>
        <zip>91403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cutler Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Quincy</city>
        <state>Illinois</state>
        <zip>62301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bay City</city>
        <state>Michigan</state>
        <zip>48706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Smithtown</city>
        <state>New York</state>
        <zip>11787</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79935</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77382</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bothell</city>
        <state>Washington</state>
        <zip>98021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>South Charleston</city>
        <state>West Virginia</state>
        <zip>25309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <reference>
    <citation>Cohen S, Samad A, Karis E, Stolshek BS, Trivedi M, Zhang H, Aras GA, Kricorian G, Chung JB. Decreased Injection Site Pain Associated with Phosphate-Free Etanercept Formulation in Rheumatoid Arthritis or Psoriatic Arthritis Patients: A Randomized Controlled Trial. Rheumatol Ther. 2019 Jun;6(2):245-254. doi: 10.1007/s40744-019-0152-8. Epub 2019 Mar 27.</citation>
    <PMID>30915626</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <results_first_submitted>August 20, 2018</results_first_submitted>
  <results_first_submitted_qc>October 1, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 31, 2018</results_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etanercept</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02986139/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02986139/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 23 centers in the United States. The first participant enrolled on 29 November 2016 and the last participant enrolled on 01 September 2017.</recruitment_details>
      <pre_assignment_details>Participants were randomized 1:1 to receive each etanercept formulation in 1 of 2 treatment sequences: AB (treatment A followed by treatment B) or BA (treatment B followed by treatment A).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sequence AB</title>
          <description>Participants received a single 50 mg subcutaneous (SC) dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 1 (Treatment A) followed by a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 8 (Treatment B).</description>
        </group>
        <group group_id="P2">
          <title>Sequence BA</title>
          <description>Participants received a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 1 (Treatment B) followed by a single 50 mg SC dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 8 (Treatment A).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Etanercept</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sequence AB</title>
          <description>Participants received a single 50 mg subcutaneous (SC) dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 1 (Treatment A) followed by a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 8 (Treatment B).</description>
        </group>
        <group group_id="B2">
          <title>Sequence BA</title>
          <description>Participants received a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 1 (Treatment B) followed by a single 50 mg SC dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 8 (Treatment A).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="56"/>
            <count group_id="B2" value="55"/>
            <count group_id="B3" value="111"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.7" spread="13.9"/>
                    <measurement group_id="B2" value="55.9" spread="13.7"/>
                    <measurement group_id="B3" value="55.3" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Actual Indication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Rheumatoid Arthritis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Psoriatic Arthritis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Injection Site Pain</title>
        <description>Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.</description>
        <time_frame>Immediately following injection of each study drug on day 1 and day 8 of this crossover study</time_frame>
        <population>The primary analysis set included all participants who received both doses of commercial and new etanercept during each study period and who completed the injection site pain score during both study periods.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept Commercial Formulation</title>
            <description>Participants received a single 50 mg SC dose of etanercept commercial formulation on either day 1 or day 8.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept New Formulation</title>
            <description>Participants received a single 50 mg SC dose of etanercept new formulation on either day 1 or day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Injection Site Pain</title>
          <description>Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.</description>
          <population>The primary analysis set included all participants who received both doses of commercial and new etanercept during each study period and who completed the injection site pain score during both study periods.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.6" spread="22.3"/>
                    <measurement group_id="O2" value="19.8" spread="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A mixed effects analysis of variance model was used to assess injection site pain with the new formulation of etanercept as the test treatment and the commercial formulation of etanercept as the reference treatment. Treatment, study period, sequence, and disease indication were evaluated as fixed effect covariates, and subject within sequence was included as a random effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.048</p_value>
            <method>Mixed effects analysis of variance model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.0</ci_lower_limit>
            <ci_upper_limit>-0.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Injection Site Pain by Disease Indication</title>
        <description>Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.</description>
        <time_frame>Immediately following injection of each study drug on day 1 and day 8 of this crossover study</time_frame>
        <population>Primary analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept Commercial Formulation - RA</title>
            <description>Participants with rheumatoid arthritis (RA) received a single 50 mg SC dose of etanercept commercial formulation.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Commercial Formulation - PsA</title>
            <description>Participants with psoriatic arthritis (PsA) received a single 50 mg SC dose of etanercept commercial formulation.</description>
          </group>
          <group group_id="O3">
            <title>Etanercept New Formulation - RA</title>
            <description>Participants with RA received a single 50 mg SC dose of etanercept new formulation.</description>
          </group>
          <group group_id="O4">
            <title>Etanercept New Formulation - PsA</title>
            <description>Participants with psoriatic arthritis (PsA) received a single 50 mg SC dose of etanercept new formulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Injection Site Pain by Disease Indication</title>
          <description>Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.</description>
          <population>Primary analysis set</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" spread="20.2"/>
                    <measurement group_id="O2" value="23.3" spread="29.0"/>
                    <measurement group_id="O3" value="20.5" spread="22.6"/>
                    <measurement group_id="O4" value="17.2" spread="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>The severity of each adverse event was graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.</description>
        <time_frame>From first dose of etanercept to 30 days after the last dose; 38 days.</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of etanercept during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept Commercial Formulation</title>
            <description>Participants received a single 50 mg SC dose of etanercept commercial formulation on either day 1 or day 8.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept New Formulation</title>
            <description>Participants received a single 50 mg SC dose of etanercept new formulation on either day 1 or day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>The severity of each adverse event was graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of etanercept during the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE leading to discontinuation of etanercept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatal adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of etanercept to 30 days after the last dose; 38 days.</time_frame>
      <desc>Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.</desc>
      <group_list>
        <group group_id="E1">
          <title>Etanercept Commercial Formulation</title>
          <description>Participants received a single 50 mg SC dose of etanercept commercial formulation on either day 1 or day 8.</description>
        </group>
        <group group_id="E2">
          <title>Etanercept New Formulation</title>
          <description>Participants received a single 50 mg SC dose of etanercept new formulation on either day 1 or day 8.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Injection site papule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Injection site warmth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Limb operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
      <email>medinfo@amgen.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02986139
org study id: 20140339
nct id: NCT02986139
lead sponsor: 
has dmc: No
The primary objective was to assess the injection site pain associated with the new
      formulation of etanercept compared with commercial etanercept in adults with rheumatoid
      arthritis (RA) or psoriatic arthritis (PsA) as measured by a visual analog scale (VAS).
This is a phase 3b, multicenter, randomized, double-blind, 2-period, 2-sequence crossover
      study in adults with RA or PsA who are naive to etanercept. The study will evaluate injection
      site pain associated with the commercial formulation of etanercept and the new formulation of
      etanercept immediately after injection of each formulation.The study will consist of a
      screening period of up to 14 days, a 2 week treatment period with a 30 day post treatment
      safety follow-up. Each dose will follow the recommended label dosing for adults with RA and
      PsA: 50 mg weekly (scheduled approximately 7 days apart).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Injection Site Pain
time frame: Immediately following injection of each study drug on day 1 and day 8 of this crossover study
description: Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.
measure: Injection Site Pain by Disease Indication
time frame: Immediately following injection of each study drug on day 1 and day 8 of this crossover study
description: Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.
measure: Number of Participants With Adverse Events
time frame: From first dose of etanercept to 30 days after the last dose; 38 days.
description: The severity of each adverse event was graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
arm group label: Sequence AB
arm group type: Experimental
description: Participants received a single 50 mg subcutaneous (SC) dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 1 (Treatment A) followed by a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 8 (Treatment B).
arm group label: Sequence BA
arm group type: Experimental
description: Participants received a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 1 (Treatment B) followed by a single 50 mg SC dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 8 (Treatment A).
intervention type: Drug
intervention name: Commercial Formulation Etanercept
description: Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the commercial formulation.
arm group label: Sequence AB
arm group label: Sequence BA
other name: Enbrel
intervention type: Drug
intervention name: New Formulation Etanercept
description: Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the new formulation.
arm group label: Sequence AB
arm group label: Sequence BA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Puerto Rico
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
citation: Cohen S, Samad A, Karis E, Stolshek BS, Trivedi M, Zhang H, Aras GA, Kricorian G, Chung JB. Decreased Injection Site Pain Associated with Phosphate-Free Etanercept Formulation in Rheumatoid Arthritis or Psoriatic Arthritis Patients: A Randomized Controlled Trial. Rheumatol Ther. 2019 Jun;6(2):245-254. doi: 10.1007/s40744-019-0152-8. Epub 2019 Mar 27.
PMID: 30915626
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Arthritis, Psoriatic
mesh term: Etanercept
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