<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/NCT03796858</url>
  </required_header>
  <id_info>
    <org_study_id>CR108573</org_study_id>
    <secondary_id>2018-003214-41</secondary_id>
    <secondary_id>CNTO1959PSA3003</secondary_id>
    <nct_id>NCT03796858</nct_id>
  </id_info>
  <brief_title>A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy</brief_title>
  <acronym>COSMOS</acronym>
  <official_title>Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutica N.V., Belgium</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutica N.V., Belgium</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants&#xD;
      with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis&#xD;
      Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psoriatic arthritis is a multi-faceted disease that impacts the joints, soft tissues, and&#xD;
      skin, all of which not only results in functional disability and impaired quality of life,&#xD;
      but participants with this disease also have increased mortality. Guselkumab is a monoclonal&#xD;
      antibody that binds to human interleukin 23 (IL-23) and inhibits IL-23 specific intracellular&#xD;
      signaling and subsequent activation and cytokine production. Investigation of guselkumab in&#xD;
      this Phase 3b PsA clinical study is supported by the favorable efficacy and safety results&#xD;
      from Phase 2 study of guselkumab in PsA and Phase 2 and Phase 3 studies in psoriasis&#xD;
      including the subset of participants with PsA. The primary hypothesis is that guselkumab 100&#xD;
      milligram (mg) at Weeks 0, 4, and every 8 weeks (q8w) thereafter is superior to placebo which&#xD;
      will be assessed by the proportion of participants achieving an American College of&#xD;
      Rheumatology (ACR 20) response at Week 24. The study includes 2 periods: A 24-week&#xD;
      double-blind, placebo-controlled period for the primary analysis of the efficacy and safety&#xD;
      of guselkumab, compared with placebo and a 32-week active-treatment and safety follow-up&#xD;
      period for additional analysis of the efficacy and safety of guselkumab. Safety will be&#xD;
      monitored throughout the study (Up to Week 56).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2019</start_date>
  <completion_date type="Actual">November 11, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The ACR 20 Response is defined as greater than or equal to (&gt;=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieve an ACR 50 Response at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The ACR 50 Response is defined as greater than or equal to (&gt;=) 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=50 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in 36-Item Short form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the participant's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The physical component summary measure is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieve Psoriatic Area and Severity Index (PASI) 100 Response at Week 24 Among Participants with &gt;=3% body Surface area Psoriatic Involvement and an Investigator's Global Assessment (IGA) Score of &gt;=2 (Mild) at Baseline</measure>
    <time_frame>Week 24</time_frame>
    <description>PASI 100 response is defined as 100% improvement in PASI score from baseline (PASI score of 0). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI scoring system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">285</enrollment>
  <condition>Arthritis, Psoriatic</condition>
  <arm_group>
    <arm_group_label>Group 1: Guselkumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive guselkumab 100 milligram (mg) Subcutaneous (SC) injection at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo SC at Week 24 to maintain the blind. At Week 16, Participants who meet the early escape criteria will receive placebo at Week 16 and guselkumab at Week 20, then guselkumab every 8 weeks (q8w).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Placebo followed by Guselkumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive placebo SC injection at Weeks 0, 4, 12, and 20, and will crossover to receive guselkumab 100 mg SC injection at Weeks 24, 28, 36, and 44. At Week 16, Participants who meet the early escape criteria will receive guselkumab at Weeks 16 and 20, then guselkumab q8w.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Guselkumab 100 mg</intervention_name>
    <description>Participants will receive guselkumab 100mg as SC injection.</description>
    <arm_group_label>Group 1: Guselkumab</arm_group_label>
    <arm_group_label>Group 2: Placebo followed by Guselkumab</arm_group_label>
    <other_name>CNTO 1959</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive placebo as SC injection.</description>
    <arm_group_label>Group 1: Guselkumab</arm_group_label>
    <arm_group_label>Group 2: Placebo followed by Guselkumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months before the first&#xD;
             administration of study intervention and meet classification criteria for Psoriatic&#xD;
             Arthritis (CASPAR) at screening&#xD;
&#xD;
          -  Have active PsA as defined by at least 3 swollen joints and at least 3 tender joints&#xD;
             at screening and at baseline&#xD;
&#xD;
          -  Have at least 1 of the PsA subsets: distal interphalangeal joint involvement,&#xD;
             polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans,&#xD;
             asymmetric peripheral arthritis, or spondylitis with peripheral arthritis&#xD;
&#xD;
          -  Have an inadequate response to anti-TNF alpha therapy, defined as presence of active&#xD;
             PsA despite previous treatment with either 1 or 2 anti-TNF alpha agents and either of&#xD;
             the following: a) Lack of benefit of an anti-TNF alpha therapy, as documented in the&#xD;
             participant history by the treating physician, after at least 12 weeks of etanercept,&#xD;
             adalimumab, golimumab, or certolizumab pegol therapy (or biosimilars) and/or at least&#xD;
             a 14-week dosage regimen (i.e., at least 4 doses) of infliximab (or biosimilars).&#xD;
             Documented lack of benefit may include inadequate improvement in joint counts, skin&#xD;
             response, physical function, or disease activity, b) Intolerance to an anti-TNF alpha&#xD;
             therapy, as documented in the patient history by the treating physician, to&#xD;
             etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab (or biosimilars,&#xD;
             if available)&#xD;
&#xD;
          -  Be willing to refrain from the use of complementary therapies for PsA or psoriasis&#xD;
             including ayurvedic medicine, traditional Taiwanese, Korean, or Chinese medications&#xD;
             and acupuncture within 2 weeks before the first study intervention administration and&#xD;
             through Week 48&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has other inflammatory diseases that might confound the evaluations of benefit of&#xD;
             guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial&#xD;
             spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis),&#xD;
             systemic lupus erythematosus, or Lyme disease&#xD;
&#xD;
          -  Has ever received more than 2 different anti-TNF alpha agents&#xD;
&#xD;
          -  Has previously received any biologic treatment (other than anti-TNF Alpha agents),&#xD;
             including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab,&#xD;
             ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment&#xD;
&#xD;
          -  Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K),&#xD;
             decernotinib (VX 509), or any other a Janus kinase (JAK) inhibitor&#xD;
&#xD;
          -  Has previously received any systemic immunosuppressants (for example, azathioprine,&#xD;
             cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea,&#xD;
             tacrolimus) within 4 weeks of the first administration of study intervention&#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>Janssen Pharmaceutica N.V., Belgium Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutica N.V., Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Saint Pierre BXL</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reuma Clinic</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic - Consulting Center II-Pleven</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Medconsult-Pleven</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment - Plovdiv</name>
      <address>
        <city>Plovdiv</city>
        <zip>4003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv</name>
      <address>
        <city>Plovdiv</city>
        <zip>4004</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center 'Teodora'</name>
      <address>
        <city>Ruse</city>
        <zip>7003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Consulting Center No 17</name>
      <address>
        <city>Sofia</city>
        <zip>1505</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Medical Academy</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pellegrin Tripode - CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lapeyronie</name>
      <address>
        <city>Montpellier, Herault</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source</name>
      <address>
        <city>Orleans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Lariboisiere</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitié-Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Toulouse - Hopital Purpan</name>
      <address>
        <city>Toulouse</city>
        <zip>30159</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Trousseau - Service de Rhumatologie</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Düsseldorf</name>
      <address>
        <city>Dusseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamburger Rheuma Forschungszentrum II</name>
      <address>
        <city>Hamburg</city>
        <zip>20095</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumazentrum Ruhrgebiet</name>
      <address>
        <city>Herne</city>
        <zip>44649</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatologische Schwerpunktpraxis</name>
      <address>
        <city>Rendsburg</city>
        <zip>24768</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus St. Josef</name>
      <address>
        <city>Wuppertal</city>
        <zip>42105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>424 Military Hospital of Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <zip>56429</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz</name>
      <address>
        <city>Budapest</city>
        <zip>1023</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz</name>
      <address>
        <city>Nyiregyhaza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAV Korhaz es Rendelointezet</name>
      <address>
        <city>Szolnok</city>
        <zip>5000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz</name>
      <address>
        <city>Székesfehérvár</city>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vital Medical Center Orvosi es Fogaszati Kozpont</name>
      <address>
        <city>Veszprem</city>
        <zip>8200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barzilai Medical Center</name>
      <address>
        <city>Ashkelon</city>
        <zip>7830604</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnai Zion Medical Center</name>
      <address>
        <city>Hifa</city>
        <zip>31048</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carmel Medical Center</name>
      <address>
        <city>Hifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Federico II</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Tor Vergata</name>
      <address>
        <city>Roma</city>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complesso Integrato Columbus</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Humanitas Hospital</name>
      <address>
        <city>Rozzano (MI)</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki Nr 2 w Bydgoszczy</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Kliniczno Badawcze</name>
      <address>
        <city>Elblag</city>
        <zip>82-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Terapii Wspolczesnej J. M. Jasnorzewska J. M. Jasnorzewska Spolka Komandytowo-Akcyjna</name>
      <address>
        <city>Lodz</city>
        <zip>90-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermed Centrum Medyczne Sp. z o.o</name>
      <address>
        <city>Lodz</city>
        <zip>90-265</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Lecznica MAK-MED. S.C.</name>
      <address>
        <city>Nadarzyn</city>
        <zip>05-830</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medycyna Kliniczna</name>
      <address>
        <city>Warsaw</city>
        <zip>00-874</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mazowieckie Centrum Reumatologii i Osteoporozy</name>
      <address>
        <city>Warszawa</city>
        <zip>04-030</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WroMedica I.Bielicka, A.Strzałkowska s.c.</name>
      <address>
        <city>Wrocław</city>
        <zip>51-685</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Garcia de Orta</name>
      <address>
        <city>Almada</city>
        <zip>2805-267</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chbv - Hosp. Infante D. Pedro</name>
      <address>
        <city>Aveiro</city>
        <zip>3814-501</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ccab - Hosp. de Braga</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ipr - Inst. Port. de Reumatologia</name>
      <address>
        <city>Lisboa</city>
        <zip>1050-034</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chlo - Hosp. Egas Moniz</name>
      <address>
        <city>Lisboa</city>
        <zip>1349-019</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chln - Hosp. Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsam - Hosp. Conde de Bertiandos</name>
      <address>
        <city>Ponte de Lima</city>
        <zip>4990-041</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelyabinck Regional Clinical Hospital</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454076</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kemerovo State Medical University</name>
      <address>
        <city>Kemerovo</city>
        <zip>650000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Centre Maximum Health</name>
      <address>
        <city>Kemerovo</city>
        <zip>650066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family polyclinic #4</name>
      <address>
        <city>Korolev</city>
        <zip>141060</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krasnodar Clinical Dermatovenerologic Dispensary</name>
      <address>
        <city>Krasnodar</city>
        <zip>350020</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krasnoyarsk State Medical University</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orenburg State Medical Academy</name>
      <address>
        <city>Orenburg</city>
        <zip>460000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rostov Regional Clinical Dermatovenerological Dispensary</name>
      <address>
        <city>Rostov</city>
        <zip>344007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryazan Regional Clinical Dermatovenerological Dispensary</name>
      <address>
        <city>Ryazan</city>
        <zip>390046</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samara Regional Clinical Hospital Named After V.D.Seredavin</name>
      <address>
        <city>Samara</city>
        <zip>443095</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sararov Regional Clinical Hospital</name>
      <address>
        <city>Saratov</city>
        <zip>410053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smolensk regional hospital on Smolensk railway station</name>
      <address>
        <city>Smolensk</city>
        <zip>214025</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leningrad region clinical hospital</name>
      <address>
        <city>St-Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tula Regional Clinical Dermatovenerological Dispensary</name>
      <address>
        <city>Tula</city>
        <zip>300053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Hospital - G.G. Kuvatov</name>
      <address>
        <city>Ufa</city>
        <zip>450005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulyanovsk Regional Clinical Hospital</name>
      <address>
        <city>Ulyanovsk</city>
        <zip>432063</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital</name>
      <address>
        <city>Velikiy Novgorod</city>
        <zip>173008</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Emergency Hospital n.a. N.V. Solovyev</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital #3</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. de Cruces</name>
      <address>
        <city>Barakaldo</city>
        <zip>48902</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Germans Trias I Pujol</name>
      <address>
        <city>Barcelona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. de Basurto</name>
      <address>
        <city>Bilbao</city>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Reina Sofia</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Ramon Y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. de Getafe</name>
      <address>
        <city>Madrid</city>
        <zip>28905</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Regional Univ. de Malaga</name>
      <address>
        <city>Málaga</city>
        <zip>29009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinico Univ. de Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Infanta Luisa</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Virgen Del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Ntra. Sra. de Valme</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Do Meixoeiro</name>
      <address>
        <city>Vigo</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council'</name>
      <address>
        <city>Cherkasy</city>
        <zip>18009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Multifield Hospital #18, Mechnikov Institute of Microbiology and Immunology of NAMS</name>
      <address>
        <city>Kharkiv</city>
        <zip>61029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital</name>
      <address>
        <city>Kharkiv</city>
        <zip>61058</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khmelnitckiy regional hospital</name>
      <address>
        <city>Khmelnytsky</city>
        <zip>29000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv City Clinical Hospital #3, National Medical University</name>
      <address>
        <city>Kyiv</city>
        <zip>02125</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center 'Consylium Medical'</name>
      <address>
        <city>Kyiv</city>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv Railway Station Clinical Hospital #2</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI 'National Scientific Center Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ME 'Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil'</name>
      <address>
        <city>Poltava</city>
        <zip>36011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital</name>
      <address>
        <city>Sumy</city>
        <zip>40031</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council</name>
      <address>
        <city>Ternopil</city>
        <zip>46002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center LTD Health Clinic Department of Cardiology and Rheumatology</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal institution Central Clinical Hospital #1 Zhytomir</name>
      <address>
        <city>Zhytomir</city>
        <zip>10002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal National Hospital for Rheumatic Diseases</name>
      <address>
        <city>Bath</city>
        <zip>BA1 1RL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cannock Chase Hospital</name>
      <address>
        <city>Cannock</city>
        <zip>WS11 5XY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chapel Allerton Hospital</name>
      <address>
        <city>Leeds</city>
        <zip>LS7 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts Health NHS Trust Whipps Cross University Hospital NHS Trust</name>
      <address>
        <city>London</city>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS Foundation Trust - Rheumatoid Arthritis (RA) Clinic</name>
      <address>
        <city>London</city>
        <zip>SE1 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Tyneside General Hospital</name>
      <address>
        <city>Newcastle</city>
        <zip>NE29 8NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peterborough City Hospital</name>
      <address>
        <city>Peterborough</city>
        <zip>PE3 9GZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haywood Hospital</name>
      <address>
        <city>Stoke on Trent</city>
        <zip>ST6 7AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torbay Hospital-Devon</name>
      <address>
        <city>Torquay</city>
        <zip>TQ2 7AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
  </removed_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003214-41/results</url>
    <description>Link to results on EudraCT registry.</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>November 29, 2021</last_update_submitted>
  <last_update_submitted_qc>November 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2021</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, Psoriatic</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials\transparency.&#xD;
As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
  </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/NCT03796858
org study id: CR108573
secondary id: 2018-003214-41
secondary id: CNTO1959PSA3003
nct id: NCT03796858
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants
      with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis
      Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint
      disease.
Psoriatic arthritis is a multi-faceted disease that impacts the joints, soft tissues, and
      skin, all of which not only results in functional disability and impaired quality of life,
      but participants with this disease also have increased mortality. Guselkumab is a monoclonal
      antibody that binds to human interleukin 23 (IL-23) and inhibits IL-23 specific intracellular
      signaling and subsequent activation and cytokine production. Investigation of guselkumab in
      this Phase 3b PsA clinical study is supported by the favorable efficacy and safety results
      from Phase 2 study of guselkumab in PsA and Phase 2 and Phase 3 studies in psoriasis
      including the subset of participants with PsA. The primary hypothesis is that guselkumab 100
      milligram (mg) at Weeks 0, 4, and every 8 weeks (q8w) thereafter is superior to placebo which
      will be assessed by the proportion of participants achieving an American College of
      Rheumatology (ACR 20) response at Week 24. The study includes 2 periods: A 24-week
      double-blind, placebo-controlled period for the primary analysis of the efficacy and safety
      of guselkumab, compared with placebo and a 32-week active-treatment and safety follow-up
      period for additional analysis of the efficacy and safety of guselkumab. Safety will be
      monitored throughout the study (Up to Week 56).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24
time frame: Week 24
description: The ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
measure: Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
time frame: Baseline, Week 24
description: The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
measure: Percentage of Participants who Achieve an ACR 50 Response at Week 24
time frame: Week 24
description: The ACR 50 Response is defined as greater than or equal to (>=) 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
measure: Change from Baseline in 36-Item Short form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
time frame: Baseline, Week 24
description: The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the participant's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The physical component summary measure is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
measure: Percentage of Participants who Achieve Psoriatic Area and Severity Index (PASI) 100 Response at Week 24 Among Participants with >=3% body Surface area Psoriatic Involvement and an Investigator's Global Assessment (IGA) Score of >=2 (Mild) at Baseline
time frame: Week 24
description: PASI 100 response is defined as 100% improvement in PASI score from baseline (PASI score of 0). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI scoring system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
arm group label: Group 1: Guselkumab
arm group type: Experimental
description: Participants will receive guselkumab 100 milligram (mg) Subcutaneous (SC) injection at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo SC at Week 24 to maintain the blind. At Week 16, Participants who meet the early escape criteria will receive placebo at Week 16 and guselkumab at Week 20, then guselkumab every 8 weeks (q8w).
arm group label: Group 2: Placebo followed by Guselkumab
arm group type: Experimental
description: Participants will receive placebo SC injection at Weeks 0, 4, 12, and 20, and will crossover to receive guselkumab 100 mg SC injection at Weeks 24, 28, 36, and 44. At Week 16, Participants who meet the early escape criteria will receive guselkumab at Weeks 16 and 20, then guselkumab q8w.
intervention type: Drug
intervention name: Guselkumab 100 mg
description: Participants will receive guselkumab 100mg as SC injection.
arm group label: Group 1: Guselkumab
arm group label: Group 2: Placebo followed by Guselkumab
other name: CNTO 1959
intervention type: Drug
intervention name: Placebo
description: Participants will receive placebo as SC injection.
arm group label: Group 1: Guselkumab
arm group label: Group 2: Placebo followed by Guselkumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutica N.V., Belgium
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country: Belgium
country: Bulgaria
country: France
country: Germany
country: Greece
country: Hungary
country: Israel
country: Italy
country: Poland
country: Portugal
country: Russian Federation
country: Spain
country: Ukraine
country: United Kingdom
country: Austria
url: https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003214-41/results
description: Link to results on EudraCT registry.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Necrosis
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.
As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu
ipd url: https://www.janssen.com/clinical-trials/transparency