Clinical Trial Details

NCT ID: NCT02438787
Date Last Changed: April 20, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Placebo, Ustekinumab 45 mg, Ustekinumab 90 mg and Golimumab 50 mg to evaluate Axial Spondyloarthritis, Anti-TNF(Alpha)

Research Study Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Subjects With Active Radiographic Axial Spondyloarthritis

Purpose

The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Janssen Research & Development, LLC
Duration
37 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria. The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met

  • Participants must have symptoms of active disease at screening and at baseline, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to ( > =4) and a visual analog scale (VAS) score for total back pain of > =4, each on a scale of 0 to 10

  • Participants with elevated high sensitivity C-reactive protein (hsCRP) level of

=0.300 milligram per deciliter (mg/dL) at screening

  • Refractory by either lack of benefit or documented intolerance to 1 and no more than 1 anti-TNF(alpha) agent

  • Inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over a 4-week period in total with maximal doses of NSAID(s), or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs.

  • Participants with complete ankylosis of the spine are permitted to be included in the study, but will be limited to approximately 10 percent (%) of the study population

Exclusion Criteria:

  • Participants who have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, or Lyme disease

  • Participants who have received infliximab or infliximab biosimilar, within 12 weeks of the first study agent administration; have received adalimumab, adalimumab biosimilar, or certolizumab pegol within 6 weeks of the first study agent administration; have received etanercept or etanercept biosimilar within 6 weeks of the first study agent administration

  • Participants who have ever received golimumab

  • Participants who are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 5 months after receiving the last administration of study agent

  • Participants who have received any systemic immunosuppressives or disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent. Medications in these categories include, but are not limited to leflunomide, chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine

Site Locations (176)

Country State City Zip Facility and Contact
United States Arizona Glendale 85306 Arizona Arthritis and Rheumatology Research, PLLC
United States Arizona Peoria 85381 Sun Valley Arthritis Center, Ltd.
United States Arizona Phoenix 85032 Arizona Arthritis and Rheumatology Research, PLLC
United States Arizona Phoenix 85037 Arizona Arthritis and Rheumatology Research, PLLC
United States California Fremont 94538 Barry Shibuya MD Inc
United States Florida Saint Petersburg 33705 BayCare Medical Group/Suncoast Medical Clinic
United States Florida Tampa 33614 BayCare Medical Group, Inc.
United States Idaho Meridian 83642 Advanced Clinical Research
United States Illinois Chicago 60612 Rush University Medical Center
United States Louisiana Monroe 71203 Arthritis and Diabetes Clinic, Inc.
United States New York Orchard Park 14127 Buffalo Rheumatology and Medicine PLLC
United States Oregon Portland 97239-3098 Oregon Health & Science University
United States Pennsylvania Duncansville 16635 Altoona Center For Clinical Research
United States Pennsylvania Wyomissing 19610 Clinical Research Center of Reading, LLC
United States Tennessee Jackson 38305 West Tennessee Research Institute
United States Texas Austin 78731 Austin Regional Clinic
United States Texas Mesquite 75150 Southwest Rheumatology Research LLC
United States Virginia Arlington 22205 Arthritis Clinic of Northern VA, P.C.
United States Washington Seattle 98133 The Seattle Arthritis Clinic
Argentina Buenos Aires C1204AAP Instituto Centenario
Argentina Ciudad De Buenos Aires C1428DQG Instituto de Rehabilitación Psicofísica
Argentina Ciudad De Buenos Aires C1430EGF Clínica Adventista Belgrano
Argentina Ciudad De La Plata B1902 Framingham Centro Médico
Argentina Ciudad De San Miguel De Tucuman T4000AXL Centro Médico Privado de Reumatología Tucumán
Argentina Cordoba 5000 Consultora Integral de Salud SRL
Belgium Brussel 1200 Cliniques Universitaires Saint-Luc
Belgium Bruxelles 1070 ULB Hôpital Erasme
Belgium Genk 3600 Reuma Clinic
Belgium Gent 9000 Universitair Ziekenhuis Gent
Belgium Leuven 3000 UZ Leuven
Belgium Liège 4000 CHU de Liège
Belgium Merksem (Antwerp) 2170 Algemeen Ziekenhuis Jan Palfijn Merksem
Brazil Campinas 13015-001 Cliníca Médica Bonfiglioli
Brazil Curitiba 80.250-060 Associação Hospitalar de Proteção à Infância Dr. Raul Carneiro
Brazil Goiânia 74110-120 CIP - Centro Internacional de Pesquisa
Brazil Juiz De Fora 36010-570 CEMiP - Centro Mineiro de Pesquisa LTDA
Brazil Porto Alegre 90035-001 Associação Hospitalar Moinhos de Vento
Brazil Porto Alegre 90035903 Hospital de Clínicas de Porto Alegre
Brazil Porto Alegre 90880-480 LMK Serviços Médicos SS LTDA
Brazil Rio De Janeiro 22271-100 CCBR
Brazil Santo André 09060-650 Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC
Brazil Sao Paulo 012440- 030 CPCLIN - Centro de Pesquisas Clínicas
Brazil São Paulo 04026-000 Centro de Pesquisa - Reumatologia - FAP- UNIFESP
Brazil São Paulo 04032-060 Hospital e Centro de Reabilitação da AACD
Bulgaria Burgas 8000 Multiprofile Hospital for Active Treatment Burgas
Bulgaria Pleven 5800 University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
Bulgaria Plovdiv 4003 Multiprofile Hospital for Active Treatment - Plovdiv
Bulgaria Plovdiv 4004 Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
Bulgaria Ruse 7002 MHAT Ruse
Bulgaria Sofia 1505 Diagnostic Consulting Center No 17
Bulgaria Sofia 1606 Military Medical Academy
Bulgaria Sofia 1612 St Ivan Rilski University Multiprofile Hospital For Active Treatment
Canada British Columbia Victoria V8V 3M9 PerCuro Clinical Research Ltd.
Canada Newfoundland and Labrador St. John'S A1C 5B8 Eastern Regional Health Authority, St. Clare's Mercy Hospital
Canada Ontario Windsor N8X 2C9 Clinical Research and Arthritis Centre
Canada Quebec G1V 3M7 G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Czechia Bruntal 79201 Revmatologie Bruntal, s.r.o.
Czechia Pardubice 53002 Arthromed, S.R.O.
Czechia Prague 5 158 00 Revma Praha s.r.o.
Czechia Praha 2 12850 Instytut Reumatologii
Czechia Praha 4 14000 Revmatologicka ambulance
Czechia Uherske Hradiste 68601 Medical Plus S.R.O.
Czechia Zlin 76001 PV-Medical S.R.O
France Boulogne-Billancourt 92100 Hopital Ambroise Pare
France Chambray-Lès-Tours 37170 CHRU de Tours - Hôpital Trousseau
France Echirolles 38130 CHU Grenoble
France Montpellier, Herault 34295 CHU Lapeyronie
France Paris 75010 Hopital Lariboisiere
France Paris 75014 Hôpital Cochin APHP
France Paris 75651 Groupe Hospitalier Pitie Salpetriere
France Rouen 76031 CHU Rouen - Hopital Charles Nicolle
France Toulouse 31059 Hopital Pierre Paul Riquet - Purpan
Germany Bad Neuheim 61231 Kerckhoff-Klinik Bad Nauheim
Germany Berlin 12203 Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
Germany Gommern 39245 Immunologisches Zentrum Vogelsang-Gommern GmbH
Germany Hamburg 20095 Hamburger Rheuma Forschungszentrum II
Germany Hamburg 22763 Asklepios Klinik Altona
Germany Herne 44649 Rheumazentrum Ruhrgebiet
Germany Koeln 50397 Universitaetsklinikum Koeln
Hungary Budapest 1023 Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
Hungary Budapest 1023 Orszagos Reumatologia es Fizioterapias Intezet
Hungary Debrecen 4032 Debreceni Egyetem Klinikai Központ
Hungary Eger 3300 Markhot Ferenc Oktatókórház és Rendelőintézet
Hungary Kistarcsa 2143 Pest Megyei Flor Ferenc Korhaz
Hungary Nyíregyháza 4400 Josa Andras Oktatokorhaz
Hungary Szolnok 5000 MAV Korhaz es Rendelointezet
Hungary Székesfehérvár 8000 Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz
Hungary Veszprém 8200 Csolnoky Ferenc Korhaz
Korea, Republic of Daegu 42415 Kyungpook National University Hospital
Korea, Republic of Daegu 705-718 Daegu Catholic University Medical Center
Korea, Republic of Daejeon 301-721 Chungnam National University Hospital
Korea, Republic of Gwangju 501-757 Chonnam National University Hospital
Korea, Republic of Jeonju 54907 Chonbuk National Univ Hospital
Korea, Republic of Seoul 05505 Asan Medical Center
Korea, Republic of Seoul 110-744 Seoul National University Hospital
Korea, Republic of Seoul 133-792 Hanyang University Hospital for rheumatic Diseases
Korea, Republic of Seoul 134-727 KyungHee University Hospital at Gangdong
Korea, Republic of Seoul 143729 Konkuk University Medical Center
Korea, Republic of Suwon 443380 Ajou University Hospital
Mexico Culiacan 80000 Centro de Investigacion de Tratamientos Innovadores de Sinaloa
Mexico Guadalajara 44160 Centro Integral en Reumatología S.A de C.V.
Mexico Guadalajara 44690 Centro de Estudios de Investigación Básica y Clínica
Mexico Mexico City 11850 Centro de Investigación y Tratamiento Reumatológico S.C.
Poland Białystok 15-297 Centrum Miriada
Poland Bydgoszcz 85-168 Szpital Uniwersytecki Nr 2 w Bydgoszczy
Poland Elblag 82-300 Centrum Kliniczno Badawcze
Poland Nadarzyn 05-830 NZOZ Lecznica MAK-MED. S.C.
Poland Szczecin 71-252 Klinika Reumatologii i Chorob Wewnetrznych PUM
Poland Torun 87-100 Nasz Lekarz, Nzoz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodn
Poland Warsawa 00-660 Medycyna Kliniczna
Poland Warszawa 03-291 Centrum Medyczne AMED Warszawa Targowek
Portugal Almada 2801-951 Hospital Garcia de Orta, EPE
Portugal Lisboa 1050-034 Instituto Portugues de Reumatologia
Portugal Lisboa 1649-035 Centro Hospitalar de Lisboa Norte - Hospital Santa Maria
Portugal Porto 4200-319 Centro Hospitalar de São João, EPE
Russian Federation Belgorod 308007 Belgorod National Research University
Russian Federation Chelyabinsk 454076 Chelyabinck Regional Clinical Hospital
Russian Federation Chita 672090 Chita State Medical Academy
Russian Federation Kazan 420012 Kazan State Medical University
Russian Federation Kemerovo 650056 Medical Centre 'Maximum Health'
Russian Federation Kemerovo 650066 Kemerovo Regional Clinical Hospital
Russian Federation Khanty-Mansiysk 628012 County Clinical Hospital
Russian Federation Kursk 305007 Kursk Regional Clinical Hospital
Russian Federation Moscow 115522 Institute of Rheumatology-Russian Academy of Medical Sciences
Russian Federation Nizhniy Novgorod 603126 Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Russian Federation Omsk 644024 Clinical Diagnostic Center 'Ultramed'
Russian Federation Orenburg 460000 Orenburg State Medical Academy
Russian Federation Petrozavodsk 185019 Republican Hospital n.a.V.A.Baranov
Russian Federation Pyatigorsk 357500 LLC Novaya Clinica
Russian Federation Saratov 410053 Saratov Regional Clinical Hospital
Russian Federation St. Petersburg 190031 LLC Sanavita
Russian Federation St.Petersburg 194291 Leningrad region clinical hospital
Russian Federation Ufa 450005 Republican Clinical Hospital - G.G. Kuvatov
Russian Federation Zelenograd 124489 City Hospital № 3
Spain A Coruna 15006 Complejo Hospitalario Universitario A Coruña
Spain Bilbao 48013 Hosp. Univ. de Basurto
Spain Córdoba 14004 Hosp. Reina Sofia
Spain L´Hospitalet De Llobregat 8907 Hosp. Univ. de Bellvitge
Spain Madrid 28034 Hosp. Univ. Ramon Y Cajal
Spain Madrid 28041 Hosp. Univ. 12 de Octubre
Spain Málaga 29010 Hosp. Regional Univ. de Malaga
Spain Sabadell 8208 Hospital Universitario Parc Tauli
Spain Santiago De Compostela 15706 Hosp. Clinico Univ. de Santiago
Spain Valencia 46026 Hosp. Univ. I Politecni La Fe
Taiwan Changhua 500 Changhua Christian Hospital
Taiwan Hualien 97002 Hualien Tzu Chi Hospital
Taiwan Kaohsiung 81362 Kaohsiung Veterans General Hospital
Taiwan Kaohsiung 83301 Kaohsiung Chang Gung Memorial Hospital
Taiwan Taichung 40201 Chung Shan Medical University Hospital
Taiwan Taichung 40447 China Medical University Hospital
Taiwan Tainan 70403 National Cheng Kung University Hospital
Taiwan Taipei 10630 Cathay General Hospital
Taiwan Taipei 11490 Tri-Service Genaral Hospital
Taiwan Taoyuan 33305 Chang Gung Memorial Hospital
Ukraine Cherkasy 18009 Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council
Ukraine Ivano-Frankivsk 76018 Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
Ukraine Kharkiv 61029 Communal Institution of Health Kharkiv City multifield hospital №18
Ukraine Kharkiv 61058 Municipal Institution of Health Care 'Regional Clinical Hospital - center of emergency medicine and
Ukraine Kyiv 01601 Oleksandrivska Clinical Hospital
Ukraine Kyiv 03049 Kyiv Railway Station Clinical Hospital #2
Ukraine Kyiv 03680 SI National Scientific Center The M.D.Strazhesko Institute of Cardiology of NAMSU
Ukraine Lviv 79010 Danylo Halytsky Lviv National Medical University
Ukraine Odessa 65026 Multidisciplinary Medical Center of Odessa National Medical University (University Clinic №1)
Ukraine Poltava 36000 Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
Ukraine Ternopil 46002 Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ukraine Ternopil 46002 Ternopil State Medical University, Department of Internal Medicine
Ukraine Uzhgorod 88000 Transcarpathian Regional Clinical Hospital
Ukraine Vinnytsya 21018 Vinnytsya State Medical University, Vinnytsya Regional Clinical Hospital
Ukraine Vinnytsya 21021 Medical Clinical Investigational Center of Medical Center "Health Clinic"
Ukraine Zaporizhzhya 69600 Zaporizhzhya Regional Clinical Hospital
United Kingdom Bath BA1 1RL Royal National Hospital For Rheumatic Diseases Nhs Foundation Trust
United Kingdom Leytonstone E11 1NR Whipps Cross University Hospital
United Kingdom London NW1 2PG University College London
United Kingdom Peterborough PE3 9GZ Peterborough City Hospital
United Kingdom Stoke On Trent ST6 7AG Haywood Hospital
United Kingdom Upton CH49 5PE Arrowe Park Hospital

Contact

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

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