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

NCT01007435 | Completed Phase 3 Results

• 2 other identifiers: WA199262009-012759-12
• Study Type: interventional
• Target: 1,162
• Locations: 35 countries
• Sites: 233

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (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.

  Week 24

Secondary Outcomes (8)

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

  Week 52

• 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

  Baseline to Weeks 24 and 52

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

  Baseline to Week 52

• Change From Baseline in Modified Sharp Erosion Score at Week 52

  Baseline to Week 52

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

  Baseline to Week 52

Study Arms (4)

(A) Tocilizumab 8 mg/kg + placebo to methotrexate

EXPERIMENTAL

Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.

Drug: Tocilizumab; Drug: Placebo to methotrexate

(B) Tocilizumab 8 mg/kg + methotrexate

EXPERIMENTAL

Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.

Drug: Tocilizumab; Drug: Methotrexate

(C) Tocilizumab 4 mg/kg + methotrexate

EXPERIMENTAL

Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.

Drug: Tocilizumab; Drug: Methotrexate

(D) Placebo to tocilizumab + methotrexate

ACTIVE COMPARATOR

Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.

Drug: Placebo to tocilizumab; Drug: Methotrexate

Interventions

Tocilizumab DRUG

Tocilizumab was supplied in vials.

Also known as: RoActemra, Actemra

(A) Tocilizumab 8 mg/kg + placebo to methotrexate; (B) Tocilizumab 8 mg/kg + methotrexate; (C) Tocilizumab 4 mg/kg + methotrexate

Placebo to tocilizumab DRUG

Placebo to tocilizumab was supplied in vials.

(D) Placebo to tocilizumab + methotrexate

Methotrexate DRUG

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.

(B) Tocilizumab 8 mg/kg + methotrexate; (C) Tocilizumab 4 mg/kg + methotrexate; (D) Placebo to tocilizumab + methotrexate

Placebo to methotrexate DRUG

Patients received placebo to methotrexate orally once a week.

(A) Tocilizumab 8 mg/kg + placebo to methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (236)

Pinnacle Research Group; Llc, Central

Anniston, Alabama, 36207, United States

Location

Rheumatology Associates of North Alabama

Huntsville, Alabama, 35801, United States

Location

Clnical & Translational Reseach Center for Alabama, PC

Tuscaloosa, Alabama, 35406, United States

Location

Arthrocare, Arthritis Care and Research, P.C.

Mesa, Arizona, 85208, United States

Location

Sun Valley Arthritis Center

Peoria, Arizona, 85381, United States

Location

Talbert Medical Group

Huntington Beach, California, 92646, United States

Location

Uni of California - San Diego; Division of Rheumatology

La Jolla, California, 92037, United States

Location

Valerius Medical Group & Research Ctr of Greater Long Beach

Los Alamitos, California, 90720, United States

Location

Sharp Rees-Stealy Medical Group

San Diego, California, 92101, United States

Location

San Diego Arthritis Med Clnc

San Diego, California, 92108, United States

Location

Denver Arthritis Clinic

Denver, Colorado, 80230-7127, United States

Location

Joao Nascimento

Bridgeport, Connecticut, 06606, United States

Location

New England Research Associates

Trumbull, Connecticut, 06611, United States

Location

Arthritis/Osteoporosis Treatment Center

Orange Park, Florida, 32073, United States

Location

Arthritis Center Palm Harbor

Palm Harbor, Florida, 34684, United States

Location

Arthritis Rsrch of Florida, Inc.

Palm Harbor, Florida, 34684, United States

Location

Burnette & Silverfield, MDS

Tampa, Florida, 33614, United States

Location

Quad City Rheumatology, Sc

Moline, Illinois, 61265, United States

Location

Illinois Bone & Joint Inst.

Morton Grove, Illinois, 60053, United States

Location

Springfield Clinic

Springfield, Illinois, 62703, United States

Location

Deerbrook Medical Associates

Vernon Hills, Illinois, 60061, United States

Location

Physician'S Clinic of Iowa

Cedar Rapids, Iowa, 52401, United States

Location

Via Christi Clinic, PA

Wichita, Kansas, 67208, United States

Location

Baton Rouge Clinic, Amc

Baton Rouge, Louisiana, 70808, United States

Location

Osteoporosis & Clinical Trials Center

Cumberland, Maryland, 21502, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Borgess Rheumatology

Kalamazoo, Michigan, 49009, United States

Location

Fiechtner Research Inc

Lansing, Michigan, 48910, United States

Location

Harbor Arthritis Center

Petoskey, Michigan, 49770, United States

Location

Park Nicollet Inst. ; Rtrc

Minneapolis, Minnesota, 55416, United States

Location

Jackson Arthritis Clinic

Flowood, Mississippi, 39232, United States

Location

North Mississippi Medical Ctr; Internal Medicine Associates

Tupelo, Mississippi, 38802, United States

Location

Depaul Medical Group-SSM Healthcare

Florissant, Missouri, 63031, United States

Location

Dartmouth-Hitchcock Medical Center, Rheumatology 5C

Lebanon, New Hampshire, 03756, United States

Location

NJP Clinical Research

Clifton, New Jersey, 07012, United States

Location

Mark Fisher Md, Facr, Llc

Haddon Heights, New Jersey, 08035, United States

Location

Albuquerque Center For Rheumatology

Albuquerque, New Mexico, 87102, United States

Location

Arthritis and Osteoporosis Associates of New Mexico

Las Cruces, New Mexico, 88011, United States

Location

Arthritis Health Associates; Clinical Research

Syracuse, New York, 13210, United States

Location

Asheville Arthritis & Osteoporosis Center, PA

Asheville, North Carolina, 28803, United States

Location

Durham Rheumatology

Durham, North Carolina, 27704, United States

Location

Ohio State University; Dept of Immunology

Columbus, Ohio, 43210, United States

Location

Southwest Rheumatology & Research Group, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Health Research of Oklahoma, Llc

Oklahoma City, Oklahoma, 73103, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Healthcare Research Consultants

Tulsa, Oklahoma, 74135, United States

Location

East Penn Rheumatology Associates, Pc

Bethlehem, Pennsylvania, 18015, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Research Center of Reading

Wyomissing, Pennsylvania, 19610, United States

Location

Piedmont Arthritis Clinic

Greenville, South Carolina, 29601, United States

Location

Amarillo Center For Clinical Research

Amarillo, Texas, 79124, United States

Location

Accurate Clinical Research

Houston, Texas, 77034, United States

Location

Houston Inst. For Clinical Research

Houston, Texas, 77074, United States

Location

Arthritis & Osteoporosis Associates, LLP

Lubbock, Texas, 79424, United States

Location

Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases

San Antonio, Texas, 78217, United States

Location

Texas Research Center

Sugar Land, Texas, 77479, United States

Location

Arthritis & Osteoporosis Clinic

Waco, Texas, 76710, United States

Location

Arthritis Northwest, Spokane

Spokane, Washington, 99204, United States

Location

Tacoma Center For Arthritis Research

Tacoma, Washington, 98405, United States

Location

Wenatchee Valley Hospital & Clinics

Wenatchee, Washington, 98801, United States

Location

Rheumatic Disease Center

Glendale, Wisconsin, 53217, United States

Location

Organizacion Medica de Investigacion

Buenos Aires, C1015ABO, Argentina

Location

Inst. de Rehabilitacion Psicofisica; Reumathology

Buenos Aires, C1428DQG, Argentina

Location

Caici; Rheumatology

Rosario, S2000PBJ, Argentina

Location

Centro Medico Privado de Reumatologia; Reumathology

San Miguel, T4000AXL, Argentina

Location

Royal Prince Alfred Hospital; Rheumatology

Camperdown, New South Wales, 2050, Australia

Location

Sunshine Coast Rheumatology Research Unit

Maroochydore, Queensland, 4558, Australia

Location

Queen Elizabeth Hospital; Rheumatology

Woodville, South Australia, 5011, Australia

Location

Menzies Research Institute

Hobart, Tasmania, 7100, Australia

Location

Cabrini Medical Centre; Rheumatology

Malvern, Victoria, 3144, Australia

Location

Worthing Hospital

Murdoch, Western Australia, 6150, Australia

Location

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

Innsbruck, 6020, Austria

Location

Kaiser Franz Josef Spital; Ii. Medizinische Abt.

Vienna, 1100, Austria

Location

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

Vienna, 1130, Austria

Location

Centro Internacional de Pesquisa; Reumatologia

Goiânia, Goiás, 74110010, Brazil

Location

Hospital das Clinicas - UFG;Reumatologia

Goiânia, Goiás, 74653-050, Brazil

Location

Centro Mineiro de Pesquisa - CMIP

Juiz de Fora, Minas Gerais, 36036-330, Brazil

Location

Centro de Estudos em Terapias Inovadoras - CETI

Curtiba, Paraná, 80030-110, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital e Maternidade Celso Pierro - PUCCamp; Reumatologia

Campinas, São Paulo, 13059-900, Brazil

Location

Universidade Federal de Sao Paulo - UNIFESP; Reumatologia

São Paulo, São Paulo, 04026-000, Brazil

Location

Centro Paulista de Investigacao Clinica - CEPIC

São Paulo, São Paulo, 04266-010, Brazil

Location

Arthritis Research Centre

Vancouver, British Columbia, V5Z 1L7, Canada

Location

Laurel Medical Clinic

Vancouver, British Columbia, V5Z 3Y1, Canada

Location

Manitoba Clinic

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Nexus Clinical Research Centre

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

Location

Dr. William G. Bensen Medicine Professional Corporation

Hamilton, Ontario, L8N 1Y2, Canada

Location

K-W Musculoskeletal Research

Kitchener, Ontario, N2M 5N6, Canada

Location

St. Joseph'S Health Care Centre; Rheumatology

London, Ontario, N6A 4V2, Canada

Location

Rheumatology Research Associates

Ottawa, Ontario, K1H 1A2, Canada

Location

Niagara Peninsula Arthritis Centre

St. Catharines, Ontario, L2N 7E4, Canada

Location

Hopital Maisonneuve- Rosemont; Rheumatology

Montreal, Quebec, H1T 2M4, Canada

Location

Institut de Rhumatologie de Montreal

Montreal, Quebec, H2L 1S6, Canada

Location

Centre de Recherche Musculo-Squelettique

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Saskatoon Osteoporosis Centre

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Centre Re Recherche Saint-Louis

Québec, G1W 4R4, Canada

Location

China-Japan Friendship Hospital

Beijing, 10029, China

Location

General Hospital of Chinese PLA; Department of Hematology

Beijing, 100853, China

Location

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, 510630, China

Location

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

Location

Riesgo De Fractura; Rheumatology

Bogotá, Colombia

Location

Hospital Pablo Tobon Uribe

Medellin-Antioquia, Colombia

Location

Reumalab Sas; Rheumatology

Medellín, Colombia

Location

Sjællands Universitetshospital, Køge; Reumatologisk Afdeling

Køge, 4600, Denmark

Location

Helsinki University Central Hospital; Rheumatology Clinic

Helsinki, 00290, Finland

Location

Kiljavan Lääketutkimus Oy

Hyvinkää, 05800, Finland

Location

CH Jean Rougier; Rhumato Reed Fonctionnelle

Cahors, 46005, France

Location

Fondation Hopital Saint Joseph; Rhumatologie

Marseille, 13285, France

Location

Hopital Lapeyronie; Immunologie Rhumatologie

Montpellier, 34295, France

Location

Hopital emile muller; Rhumatologie

Mulhouse, 68070, France

Location

Hopital Porte Madeleine; Service de Rhumatologie

Orléans, 45032, France

Location

Ch Pitie Salpetriere; Rhumatologie

Paris, 75651, France

Location

Hopital Purpan; Rhumatologie

Toulouse, 31059, France

Location

Kerckhoff-Klinik; Rheumatologie&klin.Immunologie

Bad Nauheim, 61231, Germany

Location

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

Baden-Baden, 76530, Germany

Location

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

Berlin, 10117, Germany

Location

Schlosspark Klinik; Abt. Rheumatologie

Berlin, 14059, Germany

Location

Klinik der Uni zu Köln; Klinik für Innere Medizin

Cologne, 50924, Germany

Location

Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

Dresden, 01307, Germany

Location

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

Erlangen, 91056, Germany

Location

Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

Hamburg, 22081, Germany

Location

Rheumapraxis PD Dr.med. Bernhard Heilig

Heidelberg, 69120, Germany

Location

Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie

Herne, 44652, Germany

Location

Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie

Hildesheim, 31134, Germany

Location

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

München, 80336, Germany

Location

Rheumapraxis an der Hase

Osnabrück, 49074, Germany

Location

Evangelisches Fachkrankenhaus; Rheumaklinik

Ratingen, 40882, Germany

Location

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

Würzburg, 97080, Germany

Location

Laiko General Hospital; Hematology Clinic

Athens, 115 27, Greece

Location

University General Hospital of Larissa; Rheumatology Unit

Larissa, 411 10, Greece

Location

Clinica Medica Del Dr Eduardo Alfredo Samayoa

Guatemala City, 01010, Guatemala

Location

Private Practice

Guatemala City, 01010, Guatemala

Location

Reuma-Centro

Guatemala City, 01015, Guatemala

Location

QUEEN MARY HOSPITAL; Division of Rheumatology & Clinical Immunology

Hong Kong, 852, Hong Kong

Location

Pamela Youde Nethersole Eastern Hospital; Department of Medicine

Hong Kong, Hong Kong

Location

Tuen Mun Hospital; Medicine & Geriatrics

Tuenmen, Hong Kong

Location

Budai Irgalmasrendi Kórház KHT. II. Reumatológia

Budapest, 1027, Hungary

Location

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

Debrecen, 4032, Hungary

Location

Markhot Ferenc Hospital; Dep. of Rheumatology

Eger, 3300, Hungary

Location

Cork Uni Hospital; Dept of Rheumatology

Cork, Ireland

Location

Adelaide and Meath Hospital; Rheumatology Department

Dublin, 24, Ireland

Location

St.Vincent's University Hospital; Rheumatology Department

Dublin, 4, Ireland

Location

Haemek Hospital; Rheumatology

Afula, 18101, Israel

Location

Barzilai; Rheumatology

Ashkelon, 78306, Israel

Location

Bnei Zion Medical Center; Rheumatology

Haifa, 3339419, Israel

Location

Hadassah University Hospital, Ein Karem; Rheumatology

Jerusalem, 9112001, Israel

Location

Hadassah Mount Scopus Hospital; Rheumatology

Jerusalem, 91240, Israel

Location

Meir Medical Center; Internal Dept A

Kfar Saba, 44281, Israel

Location

Chaim Sheba Medical Center; Rheumatology

Ramat Gan, 5262000, Israel

Location

Chaim Sheba Medical Center; Interna Dept B

Ramat Gan, 52621, Israel

Location

Policlinico Universitario; Cattedra Di Reumatologia, Edificio 3

Napoli, Campania, 80131, Italy

Location

Istituto Ortopedico Rizzoli; Unità di Reumatologia

Bologna, Emilia-Romagna, 40136, Italy

Location

Arcispedale Santa Maria Nuova; Reumatologia

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

Campus Bio-Medico; Immunologia e Allergologia

Rome, Lazio, 00128, Italy

Location

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

Rome, Lazio, 00161, Italy

Location

Università Degli Studi Di Genova - Dimi; Reumatologia

Genoa, Liguria, 16132, Italy

Location

Ospedale Di Magenta Fornaroli; U.O. Di Reumatologia

Magenta, Lombardy, 20013, Italy

Location

ASST FATEBENEFRATELLI SACCO; Reumatologia (Sacco)

Milan, Lombardy, 20157, Italy

Location

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

Turin, Piedmont, 10154, Italy

Location

Policlinico Universitario Di Cagliari

Monserrato, Sardinia, 09042, Italy

Location

Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

Culiacán, Sinaloa, 80000, Mexico

Location

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

Guadalajara, 44690, Mexico

Location

Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

Mexicali, 21100, Mexico

Location

Unidad De Enfermedades; Cronico Degenerativas, SC.

México, 44620, Mexico

Location

Cliditer SA de CV

Miexico City, 06700, Mexico

Location

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

Morelia, 58070, Mexico

Location

Hospital Universitario de Saltillo

Saltillo, 25000, Mexico

Location

Unidad de Enfermedades Reumaticas y Cronicodegenerativas

Torreón, 27000, Mexico

Location

North Shore Hospital, STAR Unit; Rheumatology Department

Auckland, New Zealand

Location

Waikato Hospital; Rheumatology Outpatients

Hamilton, 3240, New Zealand

Location

Timaru Hospital

Timaru, 7910, New Zealand

Location

Clinic of Rheumatology; Clinical Centre Skopje

Skopje, 1000, North Macedonia

Location

Centro de Infusion Marbella; Consultorios Royal Center Num 214

Panama City, 32400, Panama

Location

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

Lima, LIMA 14, Peru

Location

Abk Reuma Srl- Medicentro

Lima, Lima 21, Peru

Location

Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

San Juán de Miraflores, 15801, Peru

Location

Philippine General Hospital; Rheumatology

Manila, 1000, Philippines

Location

Jose Reyes Memorial Medical Center

Manila, 1003, Philippines

Location

Uni of Santo Tomas Hospital; Rheumatology

Manila, 1015, Philippines

Location

Szpital Specjalistyczny Nr 1; Oddzial Reumatologii I Rehabilitacji

Bytom, 41-902, Poland

Location

Wojewodzki Szpital Zespolony; Oddzial Reumatologii

Elblag, 82-300, Poland

Location

NZOZ REUMED Sp. z o.o.

Lublin, 20-607, Poland

Location

Medyczne Centrum Hetmanska; Indywidualna Specjalistyczna Praktyka Lekarska

Poznan, 60-218, Poland

Location

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

Szczecin, 71-252, Poland

Location

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

Warsaw, 02-637, Poland

Location

HUC; Servico de Reumatologia

Coimbra, 3000-075, Portugal

Location

Hospital de Santa Maria; Servico de Reumatologia

Lisbon, 1649-035, Portugal

Location

Hospital de Sao Joao; Servico de Reumatologia

Porto, 4200-319, Portugal

Location

Ponce School of Medicine; Caimed Center

Ponce, 00716, Puerto Rico

Location

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

Moscow, 105203, Russia

Location

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

Moscow, 115522, Russia

Location

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

Moscow, 115682, Russia

Location

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

Moscow, 119049, Russia

Location

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

Moscow, 129327, Russia

Location

Ryazan State Medical University Named after I.P.Pavlov

Ryazan, 390011, Russia

Location

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

Saint Petersburg, 195067, Russia

Location

State institution of healthcare "Regional hospital for war veterans"

Saratov, 410002, Russia

Location

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

Tula, 300053, Russia

Location

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

Voronezh, 394066, Russia

Location

State Institution of Healthcare of Yaroslavl Region Clinical Hospital #8

Yaroslavl, 150030, Russia

Location

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

Yekaterinburg, 620102, Russia

Location

National University Hospital; Dept of Medicine

Singapore, 117599, Singapore

Location

Netcare Private Hospital

Bloemfontein, 9301, South Africa

Location

St Augustines Hospital; Rheumatology

Durban, 4001, South Africa

Location

Greenacres Hospital

Port Elizabeth, 6045, South Africa

Location

Clinical Research Unit

Pretoria, 0083, South Africa

Location

Winelands Research Centre

Stellenbosch, 7600, South Africa

Location

Hospital de Merida ;Servicio de Reumatologia

Mérida, Badajoz, 06800, Spain

Location

Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Reumatologia

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Hospital Infanta Sofia; Servicio de Reumatologia

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Hospital Univ. Central de Asturias; Servicio de Reumatologia

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Reumatologia

Córdoba, 14004, Spain

Location

Hospital General Universitario de Guadalajara; Servicio de Reumatologia

Guadalajara, 19002, Spain

Location

Hospital Universitario de la Princesa; Servicio de Reumatologia

Madrid, 28006, Spain

Location

Hospital Universitario Virgen del Rocio; Servicio de Reumatologia

Seville, 41013, Spain

Location

Hospital Univ. Nuestra Señora de Valme; Servicio de Reumatologia

Seville, 41014, Spain

Location

Karolinska University Hospital, Huddinge; Rheumatology

Huddinge, SE-141 86, Sweden

Location

Karolinska Sjukhuset; Reumatologkliniken D2-1

Stockholm, 171 76, Sweden

Location

Chulalongkorn Hospital; Division of Rheumatology - Medicine

Bangkok, 10330, Thailand

Location

Phramongkutklao Hospital; Dept. of Medicine, Rheumatology

Bangkok, 10400, Thailand

Location

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

Bangkok, 10400, Thailand

Location

Songklanagarind Hospital; Department of Internal Medicine, Division of Rheumatology

Songkhla, 90110, Thailand

Location

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

Istanbul, 34098, Turkey (Türkiye)

Location

Addenbrooke'S Hospital; Rheumatology Research Unit

Cambridge, CB2 2QQ, United Kingdom

Location

Cannock Chase Hospital; Rheumatology

Cannock, WS11 5XY, United Kingdom

Location

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

Russells Hall Hospital; Rheumatology Department

Dudley, DY1 2HQ, United Kingdom

Location

Maidstone Hospital; Dept of Rheumatology

Maidstone, ME16 9QQ, United Kingdom

Location

Trafford General Hospital; Rheumatology

Manchester, M41 5SL, United Kingdom

Location

Arrowe Park Hospital; Rheumatology Dept

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

Location

Royal Victoria Infirmary; Clinical Research Facility

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

North Tyneside General Hospital

North Shields, NE29 8NH, United Kingdom

Location

Royal Hallamshire Hospital; Rheumatology

Sheffield, S10 2JF, United Kingdom

Location

Haywood Hospital; Staffordshire Rheumatology Centre

Stoke-on-Trent, ST6 7AG, United Kingdom

Location

Torbay Hospital; Dept of Rhematology

Torquay, TQ2 7AA, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28389552 DERIVED

• 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.

  PMID: 26511996 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: October 31, 2009
• Primary Completion: May 31, 2012
• Study Completion: January 28, 2014
• Last Updated: July 26, 2017
• Results First Posted: July 12, 2013

Record last verified: 2017-06

Locations

NZ (3); PE (3); AR (4); RU (12); HK (3); TH (4); CA (14); IT (10); DK (1); SG (1); SE (2); CN (4); PR (1); BR (8); GR (2); AU (6); TU (1); PA (1); US (61); IE (3); PT (3); ES (10); GB (12); ME (8); ZA (5); DE (15); PL (6); NO (1); CO (3); IL (8); GU (3); PH (3); HU (3); FI (2); FR (7)