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Spots Global Cancer Trial Database for Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

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Trial Identification

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

Interventions

Guselkumab
Placebo

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Janssen Research & Development, LLC Clinical Trial

Affiliation: Janssen Research & Development, LLC

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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