251
Participants
Start Date
July 22, 2013
Primary Completion Date
April 11, 2016
Study Completion Date
June 4, 2018
Tocilizumab
Tocilizumab will be administered at a dose of 162 mg as SC injection qw or q2w for 52 weeks in Part 1 of the study and at a dose 162 mg as SC injection qw for 104 week at the discretion of the investigator in Part 2 of the study.
Prednisone
Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.
Tocilizumab Placebo
Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
Prednisone Placebo
Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.
Corticosteroids
Participants without sustained remission at Week 52 will receive corticosteroids at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.
Methotrexate
Participants without sustained remission at Week 52 will receive methotrexate at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.
Hospital Erasme, Brussels
UZ Leuven Gasthuisberg, Leuven
Nordsjællands Hospital - Hillerød;Department of Rheumatology 0731, Hillerød
Sørlandet Sykehus Kristiansand, Kristiansand
University of Barcelona; Dept. of Internal Medicine,, Barcelona
Hospital For Special Surgery; Dept of Medicine - Rheumatology, New York
Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie, Berlin
Hôpital de la Conception, Marseille
Schlosspark Klinik; Abt. Rheumatologie, Berlin
Hospital Univ A Coruna; Rheumatology, A Coruña
Università Degli Studi Di Genova - Dimi; Reumatologia, Genoa
University of Pennsylvania, Philadelphia
Irccs San Raffele; Div Med Gen Immunologia Clinica, Milan
Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie, Bad Bramstedt
Asheville Arthritis & Osteoporosis Center, PA, Asheville
Hopital La Cavale Blanche; Rhumatologie, Brest
Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie, Hanover
Policlinico Univ. Uni Degli Sudi Di Udine; Clinica Di Reumatologia, Udine
Rheumatology Assoc. of S. Florida - Clinical Research Center, Boca Raton
Sarasota Arthritis Res Center, Sarasota
Azienda Ospedaliera di Padova; Cattedra e Divisione di Reumatologia, Padua
Azienda Ospedaliera di Verona-Ospedale Civile Maggiore, Verona
Hospital Universitario de Canarias;servicio de Reumatologia, San Cristóbal de La Laguna
Four Rivers Clinical Research Inc., Paducah
Arcispedale Santa Maria Nuova; Reumatologia, Reggio Emilia
Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie, Herne
Hospital de Basurto; Servicio de Reumatologia, Bilbao
Shores Rheumatology, Saint Clair Shores
Marshfield Clinic Wausau Ctr, Wausau
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie, Mainz
Mayo Clinic Rochester, Rochester
A.O. Universitaria Pisana; Psichiatria, Pisa
Hopital Claude Huriez; Internal Medicine, Lille
Hopital Emile Muller; Medecine Interne, Mulhouse
Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II, Tübingen
Kreiskliniken Esslingen gGmbH Klinik Plochingen Medizinische Klinik, Plochingen
Hopital Cochin; Medecine Interne, Paris
Universitätsklinikum Freiburg, Freiburg im Breisgau
Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV, München
University of Utah; Division of Rheumatology, Salt Lake City
Univ of Calif., Los Angeles; Rheumatology, Los Angeles
Cedars-Sinai Medical Center, Los Angeles
Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie, Erlangen
Hopital Avicenne; Medecine Interne H5, Bobigny
Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie, Bad Abbach
Rheumatology Associates, Portland
Massachusetts General Hospital, Boston
Clin. de Rhumatologie, Trois-Rivières
"Universitätsklinikum Carl Gustav Carus; Medizinische Klinik III", Dresden
Universitätsklinikum Jena; Klinik für Innere Medizin III, Jena
VU Medisch Centrum; Reumatologie 4-A-A2, Amsterdam
Ziekenhuis Rijnstate, Arnhem
Universitair Medisch Centrum Groningen, Groningen
Ziekenhuisgroep Twente, Hengelo, Hengelo
Akademisch Ziekenhuis St. Radboud; Rheumatology, Nijmegen
Ålesund sjukehus, Ålesund
Rikshospitalet; Revmatologisk Avd Seksjon Barnerevmatologi, Oslo
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela, Bydgoszcz
Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1, Szczecin
Hospital Geral de Santo Antonio; Servico de Imunologia Clinica, Porto
Hospital Universitari de Bellvitge; Servicio de Reumatologia, Barcelona
Sahlgrenska Universitetssjukhuset, Gothenburg
Skånes Universitetssjukhus, Lund
Skånes Universitetssjukhus Malmö; Reumatologkliniken, Malmo
Karolinska Sjukhuset; Reumatologkliniken D2-1, Stockholm
Akademiska Sjukhuset; Lungmedicinska Kliniken, Uppsala
Aberdeen Royal Infirmary; Medical Oncology Dept, Aberdeen
Barnsley General Hospital; Rheumatology, Barnsley
Old Queen Elizabeth Hospital; Pharmacy Building;Clinical Research offices, Birmingham
Colchester General Hospital; Aseptic Dept, Pharmacy Support Unit, Colchester, Essex
University of Edinburgh; The Queens Medical Research Institute, Edinburgh
CHAPEL ALLERTON HOSPITAL; Unit of Musculoskeletal Disease, Leeds
Moorfields Eye Hospital NHS Foundation Trust, London
Freeman Hospital; Dept of Rheumatology, Newcastle upon Tyne
Queen's Hospital, Romford
Haywood Hospital; Staffordshire Rheumatology Centre, Stoke-on-Trent
Royal Cornwall Hospital; Rhuematololgy Dept, Truro
Southend Hospital; Rheumatology Department, Westcliffe-on-sea
Hoffmann-La Roche
INDUSTRY