A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Adult patients ≥ 18 years of age.
- Rheumatoid arthritis of ≤ 2 years duration.
- Disease Activity Score 28 (DAS28) > 3.2.
- Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.
- Rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative > 1 erosion required at screening).
- Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L at screening.
Exclusion Criteria:
- Previous treatment with tocilizumab.
- Previous treatment with methotrexate or biologic agent.
- Rheumatic autoimmune disease other than rheumatoid arthritis (RA).
- History of or current inflammatory joint disease other than RA.
- Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in RA.
Sites / Locations
- Pinnacle Research Group; Llc, Central
- Rheumatology Associates of North Alabama
- Clnical & Translational Reseach Center for Alabama, PC
- Arthrocare, Arthritis Care and Research, P.C.
- Sun Valley Arthritis Center
- Talbert Medical Group
- Uni of California - San Diego; Division of Rheumatology
- Valerius Medical Group & Research Ctr of Greater Long Beach
- Sharp Rees-Stealy Medical Group
- San Diego Arthritis Med Clnc
- Denver Arthritis Clinic
- Joao Nascimento
- New England Research Associates
- Arthritis/Osteoporosis Treatment Center
- Arthritis Center Palm Harbor
- Arthritis Rsrch of Florida, Inc.
- Burnette & Silverfield, MDS
- Quad City Rheumatology, Sc
- Illinois Bone & Joint Inst.
- Springfield Clinic
- Deerbrook Medical Associates
- Physician'S Clinic of Iowa
- Via Christi Clinic, PA
- Baton Rouge Clinic, Amc
- Osteoporosis & Clinical Trials Center
- UMass Memorial Medical Center
- Borgess Rheumatology
- Fiechtner Research Inc
- Harbor Arthritis Center
- Park Nicollet Inst. ; Rtrc
- Jackson Arthritis Clinic
- North Mississippi Medical Ctr; Internal Medicine Associates
- Depaul Medical Group-SSM Healthcare
- Dartmouth-Hitchcock Medical Center, Rheumatology 5C
- NJP Clinical Research
- Mark Fisher Md, Facr, Llc
- Albuquerque Center For Rheumatology
- Arthritis and Osteoporosis Associates of New Mexico
- Arthritis Health Associates; Clinical Research
- Asheville Arthritis & Osteoporosis Center, PA
- Durham Rheumatology
- Ohio State University; Dept of Immunology
- Southwest Rheumatology & Research Group, LLC
- Health Research of Oklahoma, Llc
- Oklahoma Medical Research Foundation
- Healthcare Research Consultants
- East Penn Rheumatology Associates, Pc
- Altoona Center For Clinical Research
- Clinical Research Center of Reading
- Piedmont Arthritis Clinic
- Amarillo Center For Clinical Research
- Accurate Clinical Research
- Houston Inst. For Clinical Research
- Arthritis & Osteoporosis Associates, LLP
- Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases
- Texas Research Center
- Arthritis & Osteoporosis Clinic
- Arthritis Northwest, Spokane
- Tacoma Center For Arthritis Research
- Wenatchee Valley Hospital & Clinics
- Rheumatic Disease Center
- Organizacion Medica de Investigacion
- Inst. de Rehabilitacion Psicofisica; Reumathology
- Caici; Rheumatology
- Centro Medico Privado de Reumatologia; Reumathology
- Royal Prince Alfred Hospital; Rheumatology
- Sunshine Coast Rheumatology Research Unit
- Queen Elizabeth Hospital; Rheumatology
- Menzies Research Institute
- Cabrini Medical Centre; Rheumatology
- Worthing Hospital
- Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
- Kaiser Franz Josef Spital; Ii. Medizinische Abt.
- Krankenhaus der stadt wien hietzing; ii. Med. Abt. / zentrum für rheumatologie
- Centro Internacional de Pesquisa; Reumatologia
- Hospital das Clinicas - UFG;Reumatologia
- Centro Mineiro de Pesquisa - CMIP
- Centro de Estudos em Terapias Inovadoras - CETI
- Hospital Sao Lucas - PUCRS
- Hospital e Maternidade Celso Pierro - PUCCamp; Reumatologia
- Universidade Federal de Sao Paulo - UNIFESP; Reumatologia
- Centro Paulista de Investigacao Clinica - CEPIC
- Arthritis Research Centre
- Laurel Medical Clinic
- Manitoba Clinic
- Nexus Clinical Research Centre
- Dr. William G. Bensen Medicine Professional Corporation
- K-W Musculoskeletal Research
- St. Joseph'S Health Care Centre; Rheumatology
- Rheumatology Research Associates
- Niagara Peninsula Arthritis Centre
- Hopital Maisonneuve- Rosemont; Rheumatology
- Institut de Rhumatologie de Montreal
- Centre de Recherche Musculo-Squelettique
- Saskatoon Osteoporosis Centre
- Centre Re Recherche Saint-Louis
- China-Japan Friendship Hospital
- General Hospital of Chinese PLA; Department of Hematology
- The Third Affiliated Hospital of Sun Yat-Sen University
- Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- Riesgo De Fractura; Rheumatology
- Hospital Pablo Tobon Uribe
- Reumalab Sas; Rheumatology
- Sjællands Universitetshospital, Køge; Reumatologisk Afdeling
- Helsinki University Central Hospital; Rheumatology Clinic
- Kiljavan Lääketutkimus Oy
- CH Jean Rougier; Rhumato Reed Fonctionnelle
- Fondation Hopital Saint Joseph; Rhumatologie
- Hopital Lapeyronie; Immunologie Rhumatologie
- Hopital emile muller; Rhumatologie
- Hopital Porte Madeleine; Service de Rhumatologie
- Ch Pitie Salpetriere; Rhumatologie
- Hopital Purpan; Rhumatologie
- Kerckhoff-Klinik; Rheumatologie&klin.Immunologie
- Rheuma-Zentrum Baden-Baden Gmbh; Klinik Für Innere Medizin-Rheumatologie
- Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie
- Schlosspark Klinik; Abt. Rheumatologie
- Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
- Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w.
- Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie
- Rheumapraxis PD Dr.med. Bernhard Heilig
- Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie
- Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie
- Klinik der Uni zu Köln; Klinik für Innere Medizin
- Klinikum der Universität München; Bereich Pettenkoferstr.; Rheumaeinheit der medizinischen Klinik IV
- Rheumapraxis an der Hase
- Evangelisches Fachkrankenhaus; Rheumaklinik
- Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie
- Laiko General Hospital; Hematology Clinic
- University General Hospital of Larissa; Rheumatology Unit
- Clinica Medica Del Dr Eduardo Alfredo Samayoa
- Private Practice
- Reuma-Centro
- QUEEN MARY HOSPITAL; Division of Rheumatology & Clinical Immunology
- Pamela Youde Nethersole Eastern Hospital; Department of Medicine
- Tuen Mun Hospital; Medicine & Geriatrics
- Budai Irgalmasrendi Kórház KHT. II. Reumatológia
- Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
- Markhot Ferenc Hospital; Dep. of Rheumatology
- Cork Uni Hospital; Dept of Rheumatology
- Adelaide and Meath Hospital; Rheumatology Department
- St.Vincent's University Hospital; Rheumatology Department
- Haemek Hospital; Rheumatology
- Barzilai; Rheumatology
- Bnei Zion Medical Center; Rheumatology
- Hadassah University Hospital, Ein Karem; Rheumatology
- Hadassah Mount Scopus Hospital; Rheumatology
- Meir Medical Center; Internal Dept A
- Chaim Sheba Medical Center; Rheumatology
- Chaim Sheba Medical Center; Interna Dept B
- Policlinico Universitario; Cattedra Di Reumatologia, Edificio 3
- Istituto Ortopedico Rizzoli; Unità di Reumatologia
- Arcispedale Santa Maria Nuova; Reumatologia
- Campus Bio-Medico; Immunologia e Allergologia
- Policlinico Umberto I - Universita' La Sapienza ; Cattedra Di Reumatologia - Dept. Terapia Medica
- Università Degli Studi Di Genova - Dimi; Reumatologia
- Ospedale Di Magenta Fornaroli; U.O. Di Reumatologia
- ASST FATEBENEFRATELLI SACCO; Reumatologia (Sacco)
- Ospedale S. Giovanni Bosco; S.C. A Direzione Uni Ria Di Immunologia Clinica
- Policlinico Universitario Di Cagliari
- Clinic of Rheumatology; Clinical Centre Skopje
- Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
- Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia
- Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
- Unidad De Enfermedades; Cronico Degenerativas, SC.
- Cliditer SA de CV
- Centro de Investigación Clínica de Morelia, S.C.; Reumatologia
- Hospital Universitario de Saltillo
- Unidad de Enfermedades Reumaticas y Cronicodegenerativas
- North Shore Hospital, STAR Unit; Rheumatology Department
- Waikato Hospital; Rheumatology Outpatients
- Timaru Hospital
- Centro de Infusion Marbella; Consultorios Royal Center Num 214
- Centro especializado de rehabilitacion fisica y del dolor cerfid - unidad de inv. En reumatologia
- Abk Reuma Srl- Medicentro
- Centro de Investigaciones Medicas/Hospital Maria Auxiliadora
- Philippine General Hospital; Rheumatology
- Jose Reyes Memorial Medical Center
- Uni of Santo Tomas Hospital; Rheumatology
- Szpital Specjalistyczny Nr 1; Oddzial Reumatologii I Rehabilitacji
- Wojewodzki Szpital Zespolony; Oddzial Reumatologii
- NZOZ REUMED Sp. z o.o.
- Medyczne Centrum Hetmanska; Indywidualna Specjalistyczna Praktyka Lekarska
- Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1
- Instytut Reumatologii im. Prof. Dr hab. Eleonory Reicher; Oddzial Wczesnej Diagnostyki Stawow
- HUC; Servico de Reumatologia
- Hospital de Santa Maria; Servico de Reumatologia
- Hospital de Sao Joao; Servico de Reumatologia
- Ponce School of Medicine; Caimed Center
- Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"
- FSBI "National medico-surgical Centre n.a. N.I. Pirogov" of the Ministry of Healthcare
- FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
- FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"
- SBIH of Moscow "City clinical hospital #1 n.a. N.I. Pirogov" of Moscow Healthcare Department
- SBIH of Moscow "City Clinical Hospital #20 of Moscow Healthcare Department"
- Ryazan State Medical University Named after I.P.Pavlov
- SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF
- State institution of healthcare "Regional hospital for war veterans"
- State Institution of Healthcare of Tula Region "Tula Regional Clinical Hospital"
- Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
- State Institution of Healthcare of Yaroslavl Region Clinical Hospital #8
- National University Hospital; Dept of Medicine
- Netcare Private Hospital
- St Augustines Hospital; Rheumatology
- Greenacres Hospital
- Clinical Research Unit
- Winelands Research Centre
- Hospital Univ. Central de Asturias; Servicio de Reumatologia
- Hospital de Merida ;Servicio de Reumatologia
- Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia
- Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Reumatologia
- Hospital Infanta Sofia; Servicio de Reumatologia
- Hospital Universitario Reina Sofia; Servicio de Reumatologia
- Hospital General Universitario de Guadalajara; Servicio de Reumatologia
- Hospital Universitario de la Princesa; Servicio de Reumatologia
- Hospital Universitario Virgen del Rocio; Servicio de Reumatologia
- Hospital Univ. Nuestra Señora de Valme; Servicio de Reumatologia
- Karolinska University Hospital, Huddinge; Rheumatology
- Karolinska Sjukhuset; Reumatologkliniken D2-1
- Chulalongkorn Hospital; Division of Rheumatology - Medicine
- Phramongkutklao Hospital; Dept. of Medicine, Rheumatology
- Ramathibodi Hospital, Mahidol Uni ; Allergy, Immunology & Rheumatology, Dept of Medicine
- Songklanagarind Hospital; Department of Internal Medicine, Division of Rheumatology
- Iu Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali; Romatoloji Bilim Dali
- Addenbrooke'S Hospital; Rheumatology Research Unit
- Cannock Chase Hospital; Rheumatology
- Royal Derby Hospital
- Russells Hall Hospital; Rheumatology Department
- Maidstone Hospital; Dept of Rheumatology
- Trafford General Hospital; Rheumatology
- Royal Victoria Infirmary; Clinical Research Facility
- North Tyneside General Hospital
- Royal Hallamshire Hospital; Rheumatology
- Haywood Hospital; Staffordshire Rheumatology Centre
- Torbay Hospital; Dept of Rhematology
- Arrowe Park Hospital; Rheumatology Dept
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
(A) Tocilizumab 8 mg/kg + placebo to methotrexate
(B) Tocilizumab 8 mg/kg + methotrexate
(C) Tocilizumab 4 mg/kg + methotrexate
(D) Placebo to tocilizumab + methotrexate
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.