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Brief Title: Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
Official Title: A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Who Had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Alpha Agent
Study ID: NCT04936308
Brief Summary: The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.
Detailed Description: PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. Guselkumab is a fully human monoclonal antibody (mAb) that binds to p19 protein subunit of interleukin (IL)-23 and blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. The primary hypothesis of this study is that guselkumab is superior to placebo as assessed by the proportion of participants who had an inadequate response (IR) and/or intolerance to one prior anti-tumor necrosis factor (anti-TNF) achieving an American College of Rheumatology 20 (ACR 20) response at Week 24. This study will consist of a screening phase (up to 6 weeks), blinded treatment phase (approximately up to 2 years), which includes a placebo-controlled period from Week 0 to Week 24, and an active-controlled treatment phase from Week 24 to Week 100, and safety follow-up phase (Week 112). Safety assessments will include physical examinations, vital signs, height, weight, electrocardiograms, and clinical safety laboratory assessments. The total duration of the study will be up to 118 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Rheumatology Associates, Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Research PLLC, Flagstaff, Arizona, United States
Arizona Arthritis and Rheumatology Research PLLC, Mesa, Arizona, United States
Arizona Arthritis and Rheumatology Research PLLC, Phoenix, Arizona, United States
Arizona Arthritis and Rheumatology Research PLLC, Phoenix, Arizona, United States
Arizona Arthritis and Rheumatology Associates, Sun City, Arizona, United States
Southern Arizona VA Healthcare System, Tucson, Arizona, United States
Unity Health-White County Medical Center, Searcy, Arkansas, United States
Newport Huntington Medical Group, Huntington Beach, California, United States
Medvin Clinical Research, Thousand Oaks, California, United States
Medvin Clinical Research, Tujunga, California, United States
Clinical Research Center of Connecticut, Danbury, Connecticut, United States
Bay Pines VA Healthcare System, Bay Pines, Florida, United States
Clinical Research of West Florida, Clearwater, Florida, United States
Omega Research Consultants, DeBary, Florida, United States
Advanced Clinical Research of Orlando, Ocoee, Florida, United States
Integral Rheumatology And Immunology Specialists, Plantation, Florida, United States
Clinical Research of West Florida, Tampa, Florida, United States
Florida Medical Clinic, P.A., Zephyrhills, Florida, United States
Great Lakes Clinical Trials, Chicago, Illinois, United States
Clinic of Robert Hozman, Skokie, Illinois, United States
The Arthritis and Diabetes Clinic, Monroe, Louisiana, United States
Johns Hopkins University, Baltimore, Maryland, United States
Klein And Associates M D P A, Hagerstown, Maryland, United States
Great Lakes Center of Rheumatology, Lansing, Michigan, United States
Arthritis and Rheumatology Center of MI, Okemos, Michigan, United States
Clinical Research Institute of Michigan, LLC, Saint Clair Shores, Michigan, United States
St. Paul Rhuematology P A, Eagan, Minnesota, United States
Arthritis Consultants, Saint Louis, Missouri, United States
Arthritis Rheumatic And Back Disease Associates, Voorhees, New Jersey, United States
Albuquerque Center for Rheumatology, Albuquerque, New Mexico, United States
Arthritis and Osteoperosis Associates of New Mexico, Las Cruces, New Mexico, United States
Buffalo Rheumatology and Medicine PLLC, Orchard Park, New York, United States
DJL Clinical Research, PLLC, Charlotte, North Carolina, United States
STAT Research, Inc., Vandalia, Ohio, United States
Health Research of Oklahoma, Oklahoma City, Oklahoma, United States
Rheumatology Associates of Oklahoma, Oklahoma City, Oklahoma, United States
Dr. Ramesh Gupta, Memphis, Tennessee, United States
Precision Comprehensive Clinical Research Solutions, Colleyville, Texas, United States
Adriana Pop Moody MD Clinic PA, Corpus Christi, Texas, United States
Metroplex Clinical Research Center, Dallas, Texas, United States
Precision Comprehensive Clinical Research Solutions, Fort Worth, Texas, United States
West Texas Clinical Research, Lubbock, Texas, United States
Southwest Rheumatology Research LLC, Mesquite, Texas, United States
Texas Rheumatology Care, Plano, Texas, United States
Advanced Rheumatology of Houston, The Woodlands, Texas, United States
DM Clinical Research, Tomball, Texas, United States
Arthritis & Osteoporosis Clinic, Waco, Texas, United States
Arthritis Northwest PLLC, Spokane, Washington, United States
Rheumatology and Pulmonary Clinic, Beckley, West Virginia, United States
Cosultorios Reumatologógicos Pampa, Buenos Aires, , Argentina
Centro Privado de Medicina Familiar, Buenos Aires, , Argentina
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich, Buenos Aires, , Argentina
CIPREC, Ciudad Autonoma de Buenos Aires, , Argentina
OMI, Ciudad Autónoma de Buenos Aires, , Argentina
Instituto de Reumatología Mendoza, Ciudad de Mendoza, , Argentina
Centro de Investigaciones Medicas Tucuman, San Miguel De Tucuman, , Argentina
Southern Clinical Research, Hobart, , Australia
Liverpool Hospital, Liverpool, , Australia
Skin Health Institute Inc., Melbourne, , Australia
Eastern Health - Box Hill Hospital, Melbourne, , Australia
UMHAT 'Dr. Georgi Stranski', EAD, Pleven, , Bulgaria
Medical Center Unimed Plovdiv, Plovdiv, , Bulgaria
UMHAT Kaspela, Plovdiv, , Bulgaria
Diagnosis-consulting centre-1, Ruse, , Bulgaria
UMHAT St. Ivan Rilski, Sfia, , Bulgaria
Military Medical Academy, Sofia, , Bulgaria
ASIMP Rheumatology Centre St Irina EOOD, Sofia, , Bulgaria
University Multiprofile Hospital Sofiamed Sofia, Sofia, , Bulgaria
Medical Centre Synexus, Sofia, , Bulgaria
RHEUMA s r o, Breclav, , Czechia
L K N Arthrocentrum, Hlucin, , Czechia
MUDr Rosypalova s r o, Ostrava, , Czechia
Arthrohelp S.R.O., Pardubice, , Czechia
Revmatologicky ustav, Praha 2, , Czechia
Medical Plus S R O, Uherske Hradiste, , Czechia
PV Medical S R O, Zlin, , Czechia
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz, Budapest, , Hungary
Uno Medical Trials Ltd., Budapest, , Hungary
Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház, Debrecen, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Gyula, , Hungary
Pest Megyei Flor Ferenc Korhaz, Kistarcsa, , Hungary
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ, Szeged, , Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz, Szekesfehervar, , Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont, Veszprem, , Hungary
Bnai Zion Medical Center, Haifa, , Israel
Rambam Health Care Campus, Haifa, , Israel
Carmel Medical Center, Hifa, , Israel
Meir Medical Center, Kfar-Sava, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Hospital Selayang, Batu Caves, , Malaysia
Hospital Pulau Pinang, George Town, , Malaysia
Hospital Raja Permaisuri Bainun, Ipoh, , Malaysia
Hospital Tuanku Jaafar, Seremban, , Malaysia
Nzoz Bif Med, Bytom, , Poland
Centrum Kliniczno Badawcze, Elblag, , Poland
Malopolskie Badania Kliniczne Sp z o o, Krakow, , Poland
Malopolskie Centrum Kliniczne, Krakow, , Poland
Centrum Medyczne Promed, Krakow, , Poland
Dermed Centrum Medyczne Sp z o o, Lodz, , Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna, Lodz, , Poland
NZOZ Lecznica MAK MED S C, Nadarzyn, , Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol, Nowa Sol, , Poland
Centrum Medyczne, Poznan, , Poland
Twoja Przychodnia, Poznan, , Poland
Lubelskie Centrum Diagnostyczne, Swidnik, , Poland
MICS Centrum Medyczne Warszawa, Warsaw, , Poland
Rheuma-Medicus, Zaklad Opieki Zdrowotnej, Warszawa, , Poland
Centrum Medyczne Reuma Park, Warszawa, , Poland
WroMedica I.Bielicka, A.Strzałkowska s.c., Wrocław, , Poland
GCM Medical Group, San Juan, , Puerto Rico
Mindful Medical Research, San Juan, , Puerto Rico
FDI Clinical Research, San Juan, , Puerto Rico
Altay Medical State University, Barnaul, , Russian Federation
Chelyabinck Regional Clinical Hospital, Chelyabinsk, , Russian Federation
Chelyabinsk Regional Clinical Dermatovenerological Dispensary, Chelyabinsk, , Russian Federation
Kemerovo State Medical University, Kemerovo, , Russian Federation
LLL Medical Center Revma-Med, Kemerovo, , Russian Federation
LLC Family Outpatient Clinic # 4, Korolev, , Russian Federation
Krasnodar Clinical Dermatovenerologic Dispensary, Krasnodar, , Russian Federation
Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon, Krasnoyarsk, , Russian Federation
Clinical-Diagnostic Center Euromedservice, JSC, Moscow, , Russian Federation
FGBU Research Institute of Rheumatology named V.A.Nasonova, Moscow, , Russian Federation
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi', Moscow, , Russian Federation
GBOU VPO Orenburg State Medical University, Orenburg, , Russian Federation
Rostov Regional Clinical Dermatovenerological Dispensary, Rostov, , Russian Federation
Saratov Regional Clinical Hospital, Saratov, , Russian Federation
Smolensk regional hospital on Smolensk railway station, Smolensk, , Russian Federation
St. Petersburg GBUZ Clinical Reumatological Hospital 25, St. Petersburg, , Russian Federation
X7 Clinical Research Company Limited, St. Petersburg, , Russian Federation
GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5', Tolyatti, , Russian Federation
Tula Regional Clinical Dermatovenerological Dispensary, Tula, , Russian Federation
Republican Clinical Hospital - G.G. Kuvatov, Ufa, , Russian Federation
Hosp. Univ. de Cruces, Barakaldo, , Spain
Hosp. Univ. de La Princesa, Madrid, , Spain
Hosp. Quiron Madrid Pozuelo, Madrid, , Spain
Hosp. Regional Univ. de Malaga, Málaga, , Spain
Clinica Gaias, Santiago de Compostela, , Spain
Hosp. Quiron Sagrado Corazon, Sevilla, , Spain
Hosp. Clinico Univ. de Valencia, Valencia, , Spain
Adana City Hospital, Adana, , Turkey
Gulhane Training and Research Hospital, Ankara, , Turkey
Ankara Bilkent City Hospital, Ankara, , Turkey
Hacettepe University Medical Faculty, Ankara, , Turkey
Akdeniz University Medical Faculty, Antalya, , Turkey
Uludag University Medical Faculty, Bursa, , Turkey
Pamukkale University Medical Faculty, Denizli, , Turkey
Osmangazi University Medical Faculty, Eskisehir, , Turkey
Istanbul University Istanbul Medical Faculty, Istanbul, , Turkey
Istanbul University Cerrahpasa Medical Faculty, Istanbul, , Turkey
Kartal Dr Lutfi Kirdar sehir Hastanesi, Istanbul, , Turkey
Marmara University Medical Faculty, Istanbul, , Turkey
Kocaeli University Medical Faculty, Kocaeli, , Turkey
Necmettin Erbakan University Meram Medical Faculty, Konya, , Turkey
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council, Cherkasy, , Ukraine
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv, , Ukraine
Khmelnitckiy regional hospital, Khmelnytsky, , Ukraine
City Clinical Hospital No. 2, Kryvyi Rih, , Ukraine
Medical Center LLC 'Harmony of Beauty', Kyiv, , Ukraine
Medical Center of 'Institute of Rheumatology', LLC, Kyiv, , Ukraine
Kyiv City Clinical Hospital #3, Kyiv, , Ukraine
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway', Kyiv, , Ukraine
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine, Kyiv, , Ukraine
Medical Center 'Consylium Medical', Kyiv, , Ukraine
Volyn Regional Clinical Hospital, Lutsk, , Ukraine
LLC Medical House, Odessa, , Ukraine
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil, Poltava, , Ukraine
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov, Vinnytsya, , Ukraine
Medical Center LLC 'Modern Clinic', Zaporizhzhya, , Ukraine
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR