Clinical trial NCT01007435: A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
Official title: A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-11-04
Enrollment: 1162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.


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.

Primary outcomes:
measure: Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52
timeFrame: Week 52
measure: Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52
timeFrame: Baseline to Weeks 24 and 52
measure: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
timeFrame: Baseline to Week 52
measure: Change From Baseline in Modified Sharp Erosion Score at Week 52
timeFrame: Baseline to Week 52
measure: Change From Baseline in Sharp Joint Space Narrowing Score at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Participants With a Major Clinical Response at Week 52
timeFrame: Baseline to Week 52
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52
timeFrame: Baseline to Weeks 24 and 52
measure: Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52
timeFrame: Baseline to Weeks 24 and 52
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group; Llc, Central
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama
state: Alabama
city: Tuscaloosa
country: United States
facility: Clnical & Translational Reseach Center for Alabama, PC
state: Alabama
city: Mesa
country: United States
facility: Arthrocare, Arthritis Care and Research, P.C.
state: Arizona
city: Peoria
country: United States
facility: Sun Valley Arthritis Center
state: Arizona
city: Huntington Beach
country: United States
facility: Talbert Medical Group
state: California
city: La Jolla
country: United States
facility: Uni of California - San Diego; Division of Rheumatology
state: California
city: Los Alamitos
country: United States
facility: Valerius Medical Group & Research Ctr of Greater Long Beach
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Med Clnc
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Bridgeport
country: United States
facility: Joao Nascimento
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates
state: Connecticut
city: Orange Park
country: United States
facility: Arthritis/Osteoporosis Treatment Center
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center Palm Harbor
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Rsrch of Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Burnette & Silverfield, MDS
state: Florida
city: Moline
country: United States
facility: Quad City Rheumatology, Sc
state: Illinois
city: Morton Grove
country: United States
facility: Illinois Bone & Joint Inst.
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Vernon Hills
country: United States
facility: Deerbrook Medical Associates
state: Illinois
city: Cedar Rapids
country: United States
facility: Physician'S Clinic of Iowa
state: Iowa
city: Wichita
country: United States
facility: Via Christi Clinic, PA
state: Kansas
city: Baton Rouge
country: United States
facility: Baton Rouge Clinic, Amc
state: Louisiana
city: Cumberland
country: United States
facility: Osteoporosis & Clinical Trials Center
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Kalamazoo
country: United States
facility: Borgess Rheumatology
state: Michigan
city: Lansing
country: United States
facility: Fiechtner Research Inc
state: Michigan
city: Petoskey
country: United States
facility: Harbor Arthritis Center
state: Michigan
city: Minneapolis
country: United States
facility: Park Nicollet Inst. ; Rtrc
state: Minnesota
city: Flowood
country: United States
facility: Jackson Arthritis Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Ctr; Internal Medicine Associates
state: Mississippi
city: Florissant
country: United States
facility: Depaul Medical Group-SSM Healthcare
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center, Rheumatology 5C
state: New Hampshire
city: Clifton
country: United States
facility: NJP Clinical Research
state: New Jersey
city: Haddon Heights
country: United States
facility: Mark Fisher Md, Facr, Llc
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Center For Rheumatology
state: New Mexico
city: Las Cruces
country: United States
facility: Arthritis and Osteoporosis Associates of New Mexico
state: New Mexico
city: Syracuse
country: United States
facility: Arthritis Health Associates; Clinical Research
state: New York
city: Asheville
country: United States
facility: Asheville Arthritis & Osteoporosis Center, PA
state: North Carolina
city: Durham
country: United States
facility: Durham Rheumatology
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University; Dept of Immunology
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest Rheumatology & Research Group, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma, Llc
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, Pc
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading
state: Pennsylvania
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic
state: South Carolina
city: Amarillo
country: United States
facility: Amarillo Center For Clinical Research
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Houston
country: United States
facility: Houston Inst. For Clinical Research
state: Texas
city: Lubbock
country: United States
facility: Arthritis & Osteoporosis Associates, LLP
state: Texas
city: San Antonio
country: United States
facility: Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases
state: Texas
city: Sugar Land
country: United States
facility: Texas Research Center
state: Texas
city: Waco
country: United States
facility: Arthritis & Osteoporosis Clinic
state: Texas
city: Spokane
country: United States
facility: Arthritis Northwest, Spokane
state: Washington
city: Tacoma
country: United States
facility: Tacoma Center For Arthritis Research
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics
state: Washington
city: Glendale
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion
city: Buenos Aires
country: Argentina
facility: Inst. de Rehabilitacion Psicofisica; Reumathology
city: Rosario
country: Argentina
facility: Caici; Rheumatology
city: San Miguel
country: Argentina
facility: Centro Medico Privado de Reumatologia; Reumathology
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital; Rheumatology
state: New South Wales
city: Maroochydore
country: Australia
facility: Sunshine Coast Rheumatology Research Unit
state: Queensland
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital; Rheumatology
state: South Australia
city: Hobart
country: Australia
facility: Menzies Research Institute
state: Tasmania
city: Malvern
country: Australia
facility: Cabrini Medical Centre; Rheumatology
state: Victoria
city: Murdoch
country: Australia
facility: Worthing Hospital
state: Western Australia
city: Innsbruck
country: Austria
facility: Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
city: Wien
country: Austria
facility: Kaiser Franz Josef Spital; Ii. Medizinische Abt.
city: Wien
country: Austria
facility: Krankenhaus der stadt wien hietzing; ii. Med. Abt. / zentrum für rheumatologie
city: Goiania
country: Brazil
facility: Centro Internacional de Pesquisa; Reumatologia
state: GO
city: Goiania
country: Brazil
facility: Hospital das Clinicas - UFG;Reumatologia
state: GO
city: Juiz de Fora
country: Brazil
facility: Centro Mineiro de Pesquisa - CMIP
state: MG
city: Curtiba
country: Brazil
facility: Centro de Estudos em Terapias Inovadoras - CETI
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Campinas
country: Brazil
facility: Hospital e Maternidade Celso Pierro - PUCCamp; Reumatologia
state: SP
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP; Reumatologia
state: SP
city: Sao Paulo
country: Brazil
facility: Centro Paulista de Investigacao Clinica - CEPIC
state: SP
city: Vancouver
country: Canada
facility: Arthritis Research Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Laurel Medical Clinic
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic
state: Manitoba
city: St John's
country: Canada
facility: Nexus Clinical Research Centre
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Dr. William G. Bensen Medicine Professional Corporation
state: Ontario
city: Kitchener
country: Canada
facility: K-W Musculoskeletal Research
state: Ontario
city: London
country: Canada
facility: St. Joseph'S Health Care Centre; Rheumatology
state: Ontario
city: Ottawa
country: Canada
facility: Rheumatology Research Associates
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Peninsula Arthritis Centre
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve- Rosemont; Rheumatology
state: Quebec
city: Montreal
country: Canada
facility: Institut de Rhumatologie de Montreal
state: Quebec
city: Trois-rivieres
country: Canada
facility: Centre de Recherche Musculo-Squelettique
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Osteoporosis Centre
state: Saskatchewan
city: Quebec
country: Canada
facility: Centre Re Recherche Saint-Louis
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: General Hospital of Chinese PLA; Department of Hematology
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-Sen University
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Bogota
country: Colombia
facility: Riesgo De Fractura; Rheumatology
city: Medellin-Antioquia
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Medellin
country: Colombia
facility: Reumalab Sas; Rheumatology
city: Køge
country: Denmark
facility: Sjællands Universitetshospital, Køge; Reumatologisk Afdeling
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital; Rheumatology Clinic
city: Hyvinkää
country: Finland
facility: Kiljavan Lääketutkimus Oy
city: Cahors
country: France
facility: CH Jean Rougier; Rhumato Reed Fonctionnelle
city: Marseille
country: France
facility: Fondation Hopital Saint Joseph; Rhumatologie
city: Montpellier
country: France
facility: Hopital Lapeyronie; Immunologie Rhumatologie
city: Mulhouse
country: France
facility: Hopital emile muller; Rhumatologie
city: Orleans
country: France
facility: Hopital Porte Madeleine; Service de Rhumatologie
city: Paris
country: France
facility: Ch Pitie Salpetriere; Rhumatologie
city: Toulouse
country: France
facility: Hopital Purpan; Rhumatologie
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik; Rheumatologie&klin.Immunologie
city: Baden-Baden
country: Germany
facility: Rheuma-Zentrum Baden-Baden Gmbh; Klinik Für Innere Medizin-Rheumatologie
city: Berlin
country: Germany
facility: Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie
city: Berlin
country: Germany
facility: Schlosspark Klinik; Abt. Rheumatologie
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
city: Erlangen
country: Germany
facility: Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w.
city: Hamburg
country: Germany
facility: Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie
city: Heidelberg
country: Germany
facility: Rheumapraxis PD Dr.med. Bernhard Heilig
city: Herne
country: Germany
facility: Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie
city: Köln
country: Germany
facility: Klinik der Uni zu Köln; Klinik für Innere Medizin
city: München
country: Germany
facility: Klinikum der Universität München; Bereich Pettenkoferstr.; Rheumaeinheit der medizinischen Klinik IV
city: Osnabrück
country: Germany
facility: Rheumapraxis an der Hase
city: Ratingen
country: Germany
facility: Evangelisches Fachkrankenhaus; Rheumaklinik
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie
city: Athens
country: Greece
facility: Laiko General Hospital; Hematology Clinic
city: Larissa
country: Greece
facility: University General Hospital of Larissa; Rheumatology Unit
city: Guatemala City
country: Guatemala
facility: Clinica Medica Del Dr Eduardo Alfredo Samayoa
city: Guatemala City
country: Guatemala
facility: Private Practice
city: Guatemala City
country: Guatemala
facility: Reuma-Centro
city: Hong Kong
country: Hong Kong
facility: QUEEN MARY HOSPITAL; Division of Rheumatology & Clinical Immunology
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital; Department of Medicine
city: Tuen Mun
country: Hong Kong
facility: Tuen Mun Hospital; Medicine & Geriatrics
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Kórház KHT. II. Reumatológia
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
city: Eger
country: Hungary
facility: Markhot Ferenc Hospital; Dep. of Rheumatology
city: Cork
country: Ireland
facility: Cork Uni Hospital; Dept of Rheumatology
city: Dublin
country: Ireland
facility: Adelaide and Meath Hospital; Rheumatology Department
city: Dublin
country: Ireland
facility: St.Vincent's University Hospital; Rheumatology Department
city: Afula
country: Israel
facility: Haemek Hospital; Rheumatology
city: Ashkelon
country: Israel
facility: Barzilai; Rheumatology
city: Haifa
country: Israel
facility: Bnei Zion Medical Center; Rheumatology
city: Jerusalem
country: Israel
facility: Hadassah University Hospital, Ein Karem; Rheumatology
city: Jerusalem
country: Israel
facility: Hadassah Mount Scopus Hospital; Rheumatology
city: Kfar Saba
country: Israel
facility: Meir Medical Center; Internal Dept A
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Rheumatology
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center; Interna Dept B
city: Napoli
country: Italy
facility: Policlinico Universitario; Cattedra Di Reumatologia, Edificio 3
state: Campania
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli; Unità di Reumatologia
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova; Reumatologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Campus Bio-Medico; Immunologia e Allergologia
state: Lazio
city: Roma
country: Italy
facility: Policlinico Umberto I - Universita' La Sapienza ; Cattedra Di Reumatologia - Dept. Terapia Medica
state: Lazio
city: Genova
country: Italy
facility: Università Degli Studi Di Genova - Dimi; Reumatologia
state: Liguria
city: Magenta
country: Italy
facility: Ospedale Di Magenta Fornaroli; U.O. Di Reumatologia
state: Lombardia
city: Milano
country: Italy
facility: ASST FATEBENEFRATELLI SACCO; Reumatologia (Sacco)
state: Lombardia
city: Torino
country: Italy
facility: Ospedale S. Giovanni Bosco; S.C. A Direzione Uni Ria Di Immunologia Clinica
state: Piemonte
city: Monserrato
country: Italy
facility: Policlinico Universitario Di Cagliari
state: Sardegna
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Clinic of Rheumatology; Clinical Centre Skopje
city: Culiacán Rosales
country: Mexico
facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
state: Sinaloa
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia
city: Mexicali
country: Mexico
facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
city: Mexico
country: Mexico
facility: Unidad De Enfermedades; Cronico Degenerativas, SC.
city: Miexico City
country: Mexico
facility: Cliditer SA de CV
city: Morelia
country: Mexico
facility: Centro de Investigación Clínica de Morelia, S.C.; Reumatologia
city: Saltillo
country: Mexico
facility: Hospital Universitario de Saltillo
city: Torreon
country: Mexico
facility: Unidad de Enfermedades Reumaticas y Cronicodegenerativas
city: Auckland
country: New Zealand
facility: North Shore Hospital, STAR Unit; Rheumatology Department
city: Hamilton
country: New Zealand
facility: Waikato Hospital; Rheumatology Outpatients
city: Timaru
country: New Zealand
facility: Timaru Hospital
city: Panama City
country: Panama
facility: Centro de Infusion Marbella; Consultorios Royal Center Num 214
city: Lima
country: Peru
facility: Centro especializado de rehabilitacion fisica y del dolor cerfid - unidad de inv. En reumatologia
city: Lima
country: Peru
facility: Abk Reuma Srl- Medicentro
city: San Juan de Miraflores
country: Peru
facility: Centro de Investigaciones Medicas/Hospital Maria Auxiliadora
city: Manila
country: Philippines
facility: Philippine General Hospital; Rheumatology
city: Manila
country: Philippines
facility: Jose Reyes Memorial Medical Center
city: Manila
country: Philippines
facility: Uni of Santo Tomas Hospital; Rheumatology
city: Bytom
country: Poland
facility: Szpital Specjalistyczny Nr 1; Oddzial Reumatologii I Rehabilitacji
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony; Oddzial Reumatologii
city: Lublin
country: Poland
facility: NZOZ REUMED Sp. z o.o.
city: Poznan
country: Poland
facility: Medyczne Centrum Hetmanska; Indywidualna Specjalistyczna Praktyka Lekarska
city: Szczecin
country: Poland
facility: Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Warszawa
country: Poland
facility: Instytut Reumatologii im. Prof. Dr hab. Eleonory Reicher; Oddzial Wczesnej Diagnostyki Stawow
city: Coimbra
country: Portugal
facility: HUC; Servico de Reumatologia
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Reumatologia
city: Porto
country: Portugal
facility: Hospital de Sao Joao; Servico de Reumatologia
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine; Caimed Center
city: Ekaterinburg
country: Russian Federation
facility: Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"
city: Moscow
country: Russian Federation
facility: FSBI "National medico-surgical Centre n.a. N.I. Pirogov" of the Ministry of Healthcare
city: Moscow
country: Russian Federation
facility: FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"
city: Moscow
country: Russian Federation
facility: SBIH of Moscow "City clinical hospital #1 n.a. N.I. Pirogov" of Moscow Healthcare Department
city: Moscow
country: Russian Federation
facility: SBIH of Moscow "City Clinical Hospital #20 of Moscow Healthcare Department"
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University Named after I.P.Pavlov
city: Saint-Petersburg
country: Russian Federation
facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF
city: Saratov
country: Russian Federation
facility: State institution of healthcare "Regional hospital for war veterans"
city: Tula
country: Russian Federation
facility: State Institution of Healthcare of Tula Region "Tula Regional Clinical Hospital"
city: Voronezh
country: Russian Federation
facility: Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
city: Yaroslavl
country: Russian Federation
facility: State Institution of Healthcare of Yaroslavl Region Clinical Hospital #8
city: Singapore
country: Singapore
facility: National University Hospital; Dept of Medicine
city: Bloemfontein
country: South Africa
facility: Netcare Private Hospital
city: Durban
country: South Africa
facility: St Augustines Hospital; Rheumatology
city: Port Elizabeth
country: South Africa
facility: Greenacres Hospital
city: Pretoria
country: South Africa
facility: Clinical Research Unit
city: Stellenbosch
country: South Africa
facility: Winelands Research Centre
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; Servicio de Reumatologia
state: Asturias
city: Merida
country: Spain
facility: Hospital de Merida ;Servicio de Reumatologia
state: Badajoz
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia
state: Cantabria
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Reumatologia
state: Las Palmas
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Infanta Sofia; Servicio de Reumatologia
state: Madrid
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Reumatologia
city: Guadalajara
country: Spain
facility: Hospital General Universitario de Guadalajara; Servicio de Reumatologia
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa; Servicio de Reumatologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Reumatologia
city: Sevilla
country: Spain
facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Reumatologia
city: Huddinge
country: Sweden
facility: Karolinska University Hospital, Huddinge; Rheumatology
city: Stockholm
country: Sweden
facility: Karolinska Sjukhuset; Reumatologkliniken D2-1
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital; Division of Rheumatology - Medicine
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital; Dept. of Medicine, Rheumatology
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital, Mahidol Uni ; Allergy, Immunology & Rheumatology, Dept of Medicine
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Rheumatology
city: Istanbul
country: Turkey
facility: Iu Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali; Romatoloji Bilim Dali
city: Cambridge
country: United Kingdom
facility: Addenbrooke'S Hospital; Rheumatology Research Unit
city: Cannock
country: United Kingdom
facility: Cannock Chase Hospital; Rheumatology
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital; Rheumatology Department
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital; Dept of Rheumatology
city: Manchester
country: United Kingdom
facility: Trafford General Hospital; Rheumatology
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary; Clinical Research Facility
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital; Rheumatology
city: Stoke-on-trent
country: United Kingdom
facility: Haywood Hospital; Staffordshire Rheumatology Centre
city: Torquay
country: United Kingdom
facility: Torbay Hospital; Dept of Rhematology
city: Wirral
country: United Kingdom
facility: Arrowe Park Hospital; Rheumatology Dept
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Blanco R, Kadva A, Dimonaco S. Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial. Ann Rheum Dis. 2017 Jul;76(7):1279-1284. doi: 10.1136/annrheumdis-2016-210561. Epub 2017 Apr 7.
citation: Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Kelman A, Dimonaco S, Mitchell N. Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial. Ann Rheum Dis. 2016 Jun;75(6):1081-91. doi: 10.1136/annrheumdis-2015-207628. Epub 2015 Oct 28.