AzTrials
AzTrials

Rheumatoid ArthritisPhase 3NCT01007435

A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

A Phase 3 study testing Tocilizumab and Methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 236 sites in 36 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Tocilizumab and Methotrexate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,162 participants
Where
236 sitesin 36 countries
Study dates
31 Oct 2009to 28 Jan 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

236 sites in 36 countries.

236 sites in 36 countries

United States61 sites

  • Albuquerque Center For Rheumatology

    Albuquerque, New Mexico, 87102

  • Amarillo Center For Clinical Research

    Amarillo, Texas, 79124

  • Pinnacle Research Group; Llc, Central

    Anniston, Alabama, 36207

  • Asheville Arthritis & Osteoporosis Center, PA

    Asheville, North Carolina, 28803

  • Baton Rouge Clinic, Amc

    Baton Rouge, Louisiana, 70808

  • East Penn Rheumatology Associates, Pc

    Bethlehem, Pennsylvania, 18015

  • Joao Nascimento

    Bridgeport, Connecticut, 06606

  • Physician'S Clinic of Iowa

    Cedar Rapids, Iowa, 52401

  • NJP Clinical Research

    Clifton, New Jersey, 07012

  • Ohio State University; Dept of Immunology

    Columbus, Ohio, 43210

  • Osteoporosis & Clinical Trials Center

    Cumberland, Maryland, 21502

  • Denver Arthritis Clinic

    Denver, Colorado, 80230-7127

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Durham Rheumatology

    Durham, North Carolina, 27704

  • Depaul Medical Group-SSM Healthcare

    Florissant, Missouri, 63031

  • Jackson Arthritis Clinic

    Flowood, Mississippi, 39232

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Piedmont Arthritis Clinic

    Greenville, South Carolina, 29601

  • Mark Fisher Md, Facr, Llc

    Haddon Heights, New Jersey, 08035

  • Accurate Clinical Research

    Houston, Texas, 77034

  • Houston Inst. For Clinical Research

    Houston, Texas, 77074

  • Talbert Medical Group

    Huntington Beach, California, 92646

  • Rheumatology Associates of North Alabama

    Huntsville, Alabama, 35801

  • Borgess Rheumatology

    Kalamazoo, Michigan, 49009

  • Uni of California - San Diego; Division of Rheumatology

    La Jolla, California, 92037

  • Fiechtner Research Inc

    Lansing, Michigan, 48910

  • Arthritis and Osteoporosis Associates of New Mexico

    Las Cruces, New Mexico, 88011

  • Dartmouth-Hitchcock Medical Center, Rheumatology 5C

    Lebanon, New Hampshire, 03756

  • Valerius Medical Group & Research Ctr of Greater Long Beach

    Los Alamitos, California, 90720

  • Arthritis & Osteoporosis Associates, LLP

    Lubbock, Texas, 79424

  • Arthrocare, Arthritis Care and Research, P.C.

    Mesa, Arizona, 85208

  • Southwest Rheumatology & Research Group, LLC

    Middleburg Heights, Ohio, 44130

  • Park Nicollet Inst. ; Rtrc

    Minneapolis, Minnesota, 55416

  • Quad City Rheumatology, Sc

    Moline, Illinois, 61265

  • Illinois Bone & Joint Inst.

    Morton Grove, Illinois, 60053

  • Health Research of Oklahoma, Llc

    Oklahoma City, Oklahoma, 73103

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Arthritis/Osteoporosis Treatment Center

    Orange Park, Florida, 32073

  • Arthritis Center Palm Harbor

    Palm Harbor, Florida, 34684

  • Arthritis Rsrch of Florida, Inc.

    Palm Harbor, Florida, 34684

  • Sun Valley Arthritis Center

    Peoria, Arizona, 85381

  • Harbor Arthritis Center

    Petoskey, Michigan, 49770

  • Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases

    San Antonio, Texas, 78217

  • Sharp Rees-Stealy Medical Group

    San Diego, California, 92101

  • San Diego Arthritis Med Clnc

    San Diego, California, 92108

  • Arthritis Northwest, Spokane

    Spokane, Washington, 99204

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Texas Research Center

    Sugar Land, Texas, 77479

  • Arthritis Health Associates; Clinical Research

    Syracuse, New York, 13210

  • Tacoma Center For Arthritis Research

    Tacoma, Washington, 98405

  • Burnette & Silverfield, MDS

    Tampa, Florida, 33614

  • New England Research Associates

    Trumbull, Connecticut, 06611

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

  • North Mississippi Medical Ctr; Internal Medicine Associates

    Tupelo, Mississippi, 38802

  • Clnical & Translational Reseach Center for Alabama, PC

    Tuscaloosa, Alabama, 35406

  • Deerbrook Medical Associates

    Vernon Hills, Illinois, 60061

  • Arthritis & Osteoporosis Clinic

    Waco, Texas, 76710

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

  • Via Christi Clinic, PA

    Wichita, Kansas, 67208

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

  • Clinical Research Center of Reading

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Germany15 sites

  • Kerckhoff-Klinik; Rheumatologie&klin.Immunologie

    Bad Nauheim, 61231

  • Rheuma-Zentrum Baden-Baden Gmbh; Klinik Für Innere Medizin-Rheumatologie

    Baden-Baden, 76530

  • Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie

    Berlin, 10117

  • Schlosspark Klinik; Abt. Rheumatologie

    Berlin, 14059

  • Klinik der Uni zu Köln; Klinik für Innere Medizin

    Cologne, 50924

  • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

    Dresden, 01307

  • Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w.

    Erlangen, 91056

  • Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

    Hamburg, 22081

  • Rheumapraxis PD Dr.med. Bernhard Heilig

    Heidelberg, 69120

  • Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie

    Herne, 44652

  • Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie

    Hildesheim, 31134

  • Klinikum der Universität München; Bereich Pettenkoferstr.; Rheumaeinheit der medizinischen Klinik IV

    München, 80336

  • Rheumapraxis an der Hase

    Osnabrück, 49074

  • Evangelisches Fachkrankenhaus; Rheumaklinik

    Ratingen, 40882

  • Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie

    Würzburg, 97080

Other trials in Germany

Canada14 sites

  • Dr. William G. Bensen Medicine Professional Corporation

    Hamilton, Ontario, L8N 1Y2

  • K-W Musculoskeletal Research

    Kitchener, Ontario, N2M 5N6

  • St. Joseph'S Health Care Centre; Rheumatology

    London, Ontario, N6A 4V2

  • Hopital Maisonneuve- Rosemont; Rheumatology

    Montreal, Quebec, H1T 2M4

  • Institut de Rhumatologie de Montreal

    Montreal, Quebec, H2L 1S6

  • Rheumatology Research Associates

    Ottawa, Ontario, K1H 1A2

  • Centre Re Recherche Saint-Louis

    Québec, G1W 4R4

  • Saskatoon Osteoporosis Centre

    Saskatoon, Saskatchewan, S7K 0H6

  • Niagara Peninsula Arthritis Centre

    St. Catharines, Ontario, L2N 7E4

  • Nexus Clinical Research Centre

    St. John's, Newfoundland and Labrador, A1A 5E8

  • Centre de Recherche Musculo-Squelettique

    Trois-Rivières, Quebec, G8Z 1Y2

  • Arthritis Research Centre

    Vancouver, British Columbia, V5Z 1L7

  • Laurel Medical Clinic

    Vancouver, British Columbia, V5Z 3Y1

  • Manitoba Clinic

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Russia12 sites

  • FSBI "National medico-surgical Centre n.a. N.I. Pirogov" of the Ministry of Healthcare

    Moscow, 105203

  • FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences

    Moscow, 115522

  • FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"

    Moscow, 115682

  • SBIH of Moscow "City clinical hospital #1 n.a. N.I. Pirogov" of Moscow Healthcare Department

    Moscow, 119049

  • SBIH of Moscow "City Clinical Hospital #20 of Moscow Healthcare Department"

    Moscow, 129327

  • Ryazan State Medical University Named after I.P.Pavlov

    Ryazan, 390011

  • SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

    Saint Petersburg, 195067

  • State institution of healthcare "Regional hospital for war veterans"

    Saratov, 410002

  • State Institution of Healthcare of Tula Region "Tula Regional Clinical Hospital"

    Tula, 300053

  • Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

    Voronezh, 394066

  • State Institution of Healthcare of Yaroslavl Region Clinical Hospital #8

    Yaroslavl, 150030

  • Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"

    Yekaterinburg, 620102

Other trials in Russia

United Kingdom12 sites

  • Addenbrooke'S Hospital; Rheumatology Research Unit

    Cambridge, CB2 2QQ

  • Cannock Chase Hospital; Rheumatology

    Cannock, WS11 5XY

  • Royal Derby Hospital

    Derby, DE22 3NE

  • Russells Hall Hospital; Rheumatology Department

    Dudley, DY1 2HQ

  • Maidstone Hospital; Dept of Rheumatology

    Maidstone, ME16 9QQ

  • Trafford General Hospital; Rheumatology

    Manchester, M41 5SL

  • Arrowe Park Hospital; Rheumatology Dept

    Metropolitan Borough of Wirral, CH49 5PE

  • Royal Victoria Infirmary; Clinical Research Facility

    Newcastle upon Tyne, NE1 4LP

  • North Tyneside General Hospital

    North Shields, NE29 8NH

  • Royal Hallamshire Hospital; Rheumatology

    Sheffield, S10 2JF

  • Haywood Hospital; Staffordshire Rheumatology Centre

    Stoke-on-Trent, ST6 7AG

  • Torbay Hospital; Dept of Rhematology

    Torquay, TQ2 7AA

Other trials in United Kingdom

Italy10 sites

  • Istituto Ortopedico Rizzoli; Unità di Reumatologia

    Bologna, Emilia-Romagna, 40136

  • Università Degli Studi Di Genova - Dimi; Reumatologia

    Genoa, Liguria, 16132

  • Ospedale Di Magenta Fornaroli; U.O. Di Reumatologia

    Magenta, Lombardy, 20013

  • ASST FATEBENEFRATELLI SACCO; Reumatologia (Sacco)

    Milan, Lombardy, 20157

  • Policlinico Universitario Di Cagliari

    Monserrato, Sardinia, 09042

  • Policlinico Universitario; Cattedra Di Reumatologia, Edificio 3

    Naples, Campania, 80131

  • Arcispedale Santa Maria Nuova; Reumatologia

    Reggio Emilia, Emilia-Romagna, 42100

  • Campus Bio-Medico; Immunologia e Allergologia

    Rome, Lazio, 00128

  • Policlinico Umberto I - Universita' La Sapienza ; Cattedra Di Reumatologia - Dept. Terapia Medica

    Rome, Lazio, 00161

  • Ospedale S. Giovanni Bosco; S.C. A Direzione Uni Ria Di Immunologia Clinica

    Turin, Piedmont, 10154

Other trials in Italy

Spain10 sites

  • Hospital Universitario Reina Sofia; Servicio de Reumatologia

    Córdoba, 14004

  • Hospital General Universitario de Guadalajara; Servicio de Reumatologia

    Guadalajara, 19002

  • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Reumatologia

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • Hospital Universitario de la Princesa; Servicio de Reumatologia

    Madrid, 28006

  • Hospital de Merida ;Servicio de Reumatologia

    Mérida, Badajoz, 06800

  • Hospital Univ. Central de Asturias; Servicio de Reumatologia

    Oviedo, Principality of Asturias, 33006

  • Hospital Infanta Sofia; Servicio de Reumatologia

    San Sebastián de los Reyes, Madrid, 28702

  • Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio; Servicio de Reumatologia

    Seville, 41013

  • Hospital Univ. Nuestra Señora de Valme; Servicio de Reumatologia

    Seville, 41014

Other trials in Spain

Brazil8 sites

  • Hospital e Maternidade Celso Pierro - PUCCamp; Reumatologia

    Campinas, São Paulo, 13059-900

  • Centro de Estudos em Terapias Inovadoras - CETI

    Curtiba, Paraná, 80030-110

  • Centro Internacional de Pesquisa; Reumatologia

    Goiânia, Goiás, 74110010

  • Hospital das Clinicas - UFG;Reumatologia

    Goiânia, Goiás, 74653-050

  • Centro Mineiro de Pesquisa - CMIP

    Juiz de Fora, Minas Gerais, 36036-330

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Universidade Federal de Sao Paulo - UNIFESP; Reumatologia

    São Paulo, São Paulo, 04026-000

  • Centro Paulista de Investigacao Clinica - CEPIC

    São Paulo, São Paulo, 04266-010

Other trials in Brazil

Israel8 sites

  • Haemek Hospital; Rheumatology

    Afula, 18101

  • Barzilai; Rheumatology

    Ashkelon, 78306

  • Bnei Zion Medical Center; Rheumatology

    Haifa, 3339419

  • Hadassah University Hospital, Ein Karem; Rheumatology

    Jerusalem, 9112001

  • Hadassah Mount Scopus Hospital; Rheumatology

    Jerusalem, 91240

  • Meir Medical Center; Internal Dept A

    Kfar Saba, 44281

  • Chaim Sheba Medical Center; Rheumatology

    Ramat Gan, 5262000

  • Chaim Sheba Medical Center; Interna Dept B

    Ramat Gan, 52621

Other trials in Israel

Mexico8 sites

  • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

    Culiacán, Sinaloa, 80000

  • Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia

    Guadalajara, 44690

  • Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

    Mexicali, 21100

  • Unidad De Enfermedades; Cronico Degenerativas, SC.

    México, 44620

  • Cliditer SA de CV

    Miexico City, 06700

  • Centro de Investigación Clínica de Morelia, S.C.; Reumatologia

    Morelia, 58070

  • Hospital Universitario de Saltillo

    Saltillo, 25000

  • Unidad de Enfermedades Reumaticas y Cronicodegenerativas

    Torreón, 27000

Other trials in Mexico

France7 sites

  • CH Jean Rougier; Rhumato Reed Fonctionnelle

    Cahors, 46005

  • Fondation Hopital Saint Joseph; Rhumatologie

    Marseille, 13285

  • Hopital Lapeyronie; Immunologie Rhumatologie

    Montpellier, 34295

  • Hopital emile muller; Rhumatologie

    Mulhouse, 68070

  • Hopital Porte Madeleine; Service de Rhumatologie

    Orléans, 45032

  • Ch Pitie Salpetriere; Rhumatologie

    Paris, 75651

  • Hopital Purpan; Rhumatologie

    Toulouse, 31059

Other trials in France

Australia6 sites

  • Royal Prince Alfred Hospital; Rheumatology

    Camperdown, New South Wales, 2050

  • Menzies Research Institute

    Hobart, Tasmania, 7100

  • Cabrini Medical Centre; Rheumatology

    Malvern, Victoria, 3144

  • Sunshine Coast Rheumatology Research Unit

    Maroochydore, Queensland, 4558

  • Worthing Hospital

    Murdoch, Western Australia, 6150

  • Queen Elizabeth Hospital; Rheumatology

    Woodville, South Australia, 5011

Other trials in Australia

Poland6 sites

  • Szpital Specjalistyczny Nr 1; Oddzial Reumatologii I Rehabilitacji

    Bytom, 41-902

  • Wojewodzki Szpital Zespolony; Oddzial Reumatologii

    Elblag, 82-300

  • NZOZ REUMED Sp. z o.o.

    Lublin, 20-607

  • Medyczne Centrum Hetmanska; Indywidualna Specjalistyczna Praktyka Lekarska

    Poznan, 60-218

  • Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1

    Szczecin, 71-252

  • Instytut Reumatologii im. Prof. Dr hab. Eleonory Reicher; Oddzial Wczesnej Diagnostyki Stawow

    Warsaw, 02-637

Other trials in Poland

South Africa5 sites

  • Netcare Private Hospital

    Bloemfontein, 9301

  • St Augustines Hospital; Rheumatology

    Durban, 4001

  • Greenacres Hospital

    Port Elizabeth, 6045

  • Clinical Research Unit

    Pretoria, 0083

  • Winelands Research Centre

    Stellenbosch, 7600

Other trials in South Africa

Argentina4 sites

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO

  • Inst. de Rehabilitacion Psicofisica; Reumathology

    Buenos Aires, C1428DQG

  • Caici; Rheumatology

    Rosario, S2000PBJ

  • Centro Medico Privado de Reumatologia; Reumathology

    San Miguel, T4000AXL

Other trials in Argentina

China4 sites

  • China-Japan Friendship Hospital

    Beijing, 10029

  • General Hospital of Chinese PLA; Department of Hematology

    Beijing, 100853

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510630

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200127

Other trials in China

Thailand4 sites

  • Chulalongkorn Hospital; Division of Rheumatology - Medicine

    Bangkok, 10330

  • Phramongkutklao Hospital; Dept. of Medicine, Rheumatology

    Bangkok, 10400

  • Ramathibodi Hospital, Mahidol Uni ; Allergy, Immunology & Rheumatology, Dept of Medicine

    Bangkok, 10400

  • Songklanagarind Hospital; Department of Internal Medicine, Division of Rheumatology

    Songkhla, 90110

Other trials in Thailand

Austria3 sites

  • Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin

    Innsbruck, 6020

  • Kaiser Franz Josef Spital; Ii. Medizinische Abt.

    Vienna, 1100

  • Krankenhaus der stadt wien hietzing; ii. Med. Abt. / zentrum für rheumatologie

    Vienna, 1130

Other trials in Austria

Colombia3 sites

  • Riesgo De Fractura; Rheumatology

    Bogotá

  • Reumalab Sas; Rheumatology

    Medellín

  • Hospital Pablo Tobon Uribe

    Medellin-Antioquia

Other trials in Colombia

Guatemala3 sites

  • Clinica Medica Del Dr Eduardo Alfredo Samayoa

    Guatemala City, 01010

  • Private Practice

    Guatemala City, 01010

  • Reuma-Centro

    Guatemala City, 01015

Other trials in Guatemala

Hong Kong3 sites

  • QUEEN MARY HOSPITAL; Division of Rheumatology & Clinical Immunology

    Hong Kong, 852

  • Pamela Youde Nethersole Eastern Hospital; Department of Medicine

    Hong Kong

  • Tuen Mun Hospital; Medicine & Geriatrics

    Tuenmen

Other trials in Hong Kong

Hungary3 sites

  • Budai Irgalmasrendi Kórház KHT. II. Reumatológia

    Budapest, 1027

  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék

    Debrecen, 4032

  • Markhot Ferenc Hospital; Dep. of Rheumatology

    Eger, 3300

Other trials in Hungary

Ireland3 sites

  • Cork Uni Hospital; Dept of Rheumatology

    Cork

  • Adelaide and Meath Hospital; Rheumatology Department

    Dublin, 24

  • St.Vincent's University Hospital; Rheumatology Department

    Dublin, 4

Other trials in Ireland

New Zealand3 sites

  • North Shore Hospital, STAR Unit; Rheumatology Department

    Auckland

  • Waikato Hospital; Rheumatology Outpatients

    Hamilton, 3240

  • Timaru Hospital

    Timaru, 7910

Other trials in New Zealand

Peru3 sites

  • Centro especializado de rehabilitacion fisica y del dolor cerfid - unidad de inv. En reumatologia

    Lima, LIMA 14

  • Abk Reuma Srl- Medicentro

    Lima, Lima 21

  • Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

    San Juán de Miraflores, 15801

Other trials in Peru

Philippines3 sites

  • Philippine General Hospital; Rheumatology

    Manila, 1000

  • Jose Reyes Memorial Medical Center

    Manila, 1003

  • Uni of Santo Tomas Hospital; Rheumatology

    Manila, 1015

Other trials in Philippines

Portugal3 sites

  • HUC; Servico de Reumatologia

    Coimbra, 3000-075

  • Hospital de Santa Maria; Servico de Reumatologia

    Lisbon, 1649-035

  • Hospital de Sao Joao; Servico de Reumatologia

    Porto, 4200-319

Other trials in Portugal

Finland2 sites

  • Helsinki University Central Hospital; Rheumatology Clinic

    Helsinki, 00290

  • Kiljavan Lääketutkimus Oy

    Hyvinkää, 05800

Other trials in Finland

Greece2 sites

  • Laiko General Hospital; Hematology Clinic

    Athens, 115 27

  • University General Hospital of Larissa; Rheumatology Unit

    Larissa, 411 10

Other trials in Greece

Sweden2 sites

  • Karolinska University Hospital, Huddinge; Rheumatology

    Huddinge, SE-141 86

  • Karolinska Sjukhuset; Reumatologkliniken D2-1

    Stockholm, 171 76

Other trials in Sweden

Denmark1 site

  • Sjællands Universitetshospital, Køge; Reumatologisk Afdeling

    Køge, 4600

Other trials in Denmark

North Macedonia1 site

  • Clinic of Rheumatology; Clinical Centre Skopje

    Skopje, 1000

Other trials in North Macedonia

Panama1 site

  • Centro de Infusion Marbella; Consultorios Royal Center Num 214

    Panama City, 32400

Other trials in Panama

Puerto Rico1 site

  • Ponce School of Medicine; Caimed Center

    Ponce, 00716

Other trials in Puerto Rico

Singapore1 site

  • National University Hospital; Dept of Medicine

    Singapore, 117599

Other trials in Singapore

Turkey (Türkiye)1 site

  • Iu Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali; Romatoloji Bilim Dali

    Istanbul, 34098

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
Tocilizumab, Placebo to tocilizumab, Methotrexate, Placebo to methotrexate
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Also called RoActemra, Actemra

    Tocilizumab was supplied in vials.

  • Placebo to tocilizumabDrug

    Placebo to tocilizumab was supplied in vials.

  • MethotrexateDrug

    Initially, patients received methotrexate 7.5 mg (3, 2.5 mg tablets) orally once a week. If a patient had swollen or tender joints, the dose was increased to 15 mg and 20 mg weekly, at the Week 4 and Week 8 visits, respectively.

  • Placebo to methotrexateDrug

    Patients received placebo to methotrexate orally once a week.

Study groups in NCT01007435
Study groupRoleWhat they receive
(A) Tocilizumab 8 mg/kg + placebo to methotrexateExperimentalPatients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
Receives: Drug: Tocilizumab; Drug: Placebo to methotrexate
(B) Tocilizumab 8 mg/kg + methotrexateExperimentalPatients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Receives: Drug: Tocilizumab; Drug: Methotrexate
(C) Tocilizumab 4 mg/kg + methotrexateExperimentalPatients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Receives: Drug: Tocilizumab; Drug: Methotrexate
(D) Placebo to tocilizumab + methotrexateActive comparatorPatients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
Receives: Drug: Placebo to tocilizumab; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24

    A participant has a DAS28 remission response if their DAS28 < 2.6. The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

    Measured: Week 24

Secondary outcomes (8)

  1. Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52

    Measured: Week 52

  2. 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

    Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" [symptom-free and no arthritis symptoms] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.

    Measured: Baseline to Weeks 24 and 52

  3. Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52

    The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint, including subluxation, is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.

    Measured: Baseline to Week 52

  4. Change From Baseline in Modified Sharp Erosion Score at Week 52

    Measured: Baseline to Week 52

  5. Change From Baseline in Sharp Joint Space Narrowing Score at Week 52

    Measured: Baseline to Week 52

  6. Percentage of Participants With a Major Clinical Response at Week 52

    A major clinical response is defined as an ACR70 response that is maintained for 6 consecutive months (24 weeks) for any 24-week period between Week 2 and Week 52.

    Measured: Baseline to Week 52

  7. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52

    The Stanford HAQ-DI is a patient completed questionnaire specific for rheumatoid arthritis. The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.

    Measured: Baseline to Weeks 24 and 52

  8. Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52

    The SF-36 Health Survey (Version 2) is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.

    Measured: Baseline to Weeks 24 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2009 (estimated)
  2. Study start31 Oct 2009
  3. Primary completion31 May 2012
  4. Study completion28 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01007435
Sponsor's protocol ID
WA19926
Other IDs
2009-012759-12, 2009
Status last verified
Jun 2017
First submitted
3 Nov 2009
Last updated
26 Jul 2017

Publications

  • 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.

    PubMed 28389552

  • 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.

    PubMed 26511996

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tocilizumab and Methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 236 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 236 sites in United States, Germany, Canada, Russia, United Kingdom and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01007435, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.

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