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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tocilizumab
Placebo to tocilizumab
Methotrexate
Placebo to methotrexate
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients ≥ 18 years of age.
  • Rheumatoid arthritis of ≤ 2 years duration.
  • Disease Activity Score 28 (DAS28) > 3.2.
  • Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.
  • Rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative > 1 erosion required at screening).
  • Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L at screening.

Exclusion Criteria:

  • Previous treatment with tocilizumab.
  • Previous treatment with methotrexate or biologic agent.
  • Rheumatic autoimmune disease other than rheumatoid arthritis (RA).
  • History of or current inflammatory joint disease other than RA.
  • Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in RA.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

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

(B) Tocilizumab 8 mg/kg + methotrexate

(C) Tocilizumab 4 mg/kg + methotrexate

(D) Placebo to tocilizumab + methotrexate

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at 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
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.
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.
Change From Baseline in Modified Sharp Erosion Score at Week 52
Change From Baseline in Sharp Joint Space Narrowing Score at Week 52
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.
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.
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.

Full Information

First Posted
November 3, 2009
Last Updated
June 28, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01007435
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 31, 2009 (Actual)
Primary Completion Date
May 31, 2012 (Actual)
Study Completion Date
January 28, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(A) Tocilizumab 8 mg/kg + placebo to methotrexate
Arm Type
Experimental
Arm Description
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
Arm Title
(B) Tocilizumab 8 mg/kg + methotrexate
Arm Type
Experimental
Arm Description
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Arm Title
(C) Tocilizumab 4 mg/kg + methotrexate
Arm Type
Experimental
Arm Description
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Arm Title
(D) Placebo to tocilizumab + methotrexate
Arm Type
Active Comparator
Arm Description
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
RoActemra, Actemra
Intervention Description
Tocilizumab was supplied in vials.
Intervention Type
Drug
Intervention Name(s)
Placebo to tocilizumab
Intervention Description
Placebo to tocilizumab was supplied in vials.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo to methotrexate
Intervention Description
Patients received placebo to methotrexate orally once a week.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52
Time Frame
Week 52
Title
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
Description
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.
Time Frame
Baseline to Weeks 24 and 52
Title
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
Description
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.
Time Frame
Baseline to Week 52
Title
Change From Baseline in Modified Sharp Erosion Score at Week 52
Time Frame
Baseline to Week 52
Title
Change From Baseline in Sharp Joint Space Narrowing Score at Week 52
Time Frame
Baseline to Week 52
Title
Percentage of Participants With a Major Clinical Response at Week 52
Description
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.
Time Frame
Baseline to Week 52
Title
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52
Description
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.
Time Frame
Baseline to Weeks 24 and 52
Title
Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52
Description
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.
Time Frame
Baseline to Weeks 24 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group; Llc, Central
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Rheumatology Associates of North Alabama
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Clnical & Translational Reseach Center for Alabama, PC
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Arthrocare, Arthritis Care and Research, P.C.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85208
Country
United States
Facility Name
Sun Valley Arthritis Center
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Talbert Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Uni of California - San Diego; Division of Rheumatology
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Valerius Medical Group & Research Ctr of Greater Long Beach
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
San Diego Arthritis Med Clnc
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230-7127
Country
United States
Facility Name
Joao Nascimento
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
New England Research Associates
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Arthritis/Osteoporosis Treatment Center
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Arthritis Center Palm Harbor
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Arthritis Rsrch of Florida, Inc.
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Burnette & Silverfield, MDS
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Quad City Rheumatology, Sc
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Illinois Bone & Joint Inst.
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Deerbrook Medical Associates
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Physician'S Clinic of Iowa
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52401
Country
United States
Facility Name
Via Christi Clinic, PA
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Baton Rouge Clinic, Amc
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Osteoporosis & Clinical Trials Center
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Borgess Rheumatology
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Fiechtner Research Inc
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Harbor Arthritis Center
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Park Nicollet Inst. ; Rtrc
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Jackson Arthritis Clinic
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
North Mississippi Medical Ctr; Internal Medicine Associates
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38802
Country
United States
Facility Name
Depaul Medical Group-SSM Healthcare
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center, Rheumatology 5C
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
NJP Clinical Research
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
Facility Name
Mark Fisher Md, Facr, Llc
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
Albuquerque Center For Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Arthritis and Osteoporosis Associates of New Mexico
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
Arthritis Health Associates; Clinical Research
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Asheville Arthritis & Osteoporosis Center, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Durham Rheumatology
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Ohio State University; Dept of Immunology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Southwest Rheumatology & Research Group, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Health Research of Oklahoma, Llc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Healthcare Research Consultants
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
East Penn Rheumatology Associates, Pc
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Research Center of Reading
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Piedmont Arthritis Clinic
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Amarillo Center For Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Houston Inst. For Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Arthritis & Osteoporosis Associates, LLP
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Texas Research Center
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Arthritis Northwest, Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Tacoma Center For Arthritis Research
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Wenatchee Valley Hospital & Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Organizacion Medica de Investigacion
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Inst. de Rehabilitacion Psicofisica; Reumathology
City
Buenos Aires
ZIP/Postal Code
C1428DQG
Country
Argentina
Facility Name
Caici; Rheumatology
City
Rosario
ZIP/Postal Code
S2000PBJ
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia; Reumathology
City
San Miguel
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Royal Prince Alfred Hospital; Rheumatology
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Sunshine Coast Rheumatology Research Unit
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Queen Elizabeth Hospital; Rheumatology
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Menzies Research Institute
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7100
Country
Australia
Facility Name
Cabrini Medical Centre; Rheumatology
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Worthing Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Kaiser Franz Josef Spital; Ii. Medizinische Abt.
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Krankenhaus der stadt wien hietzing; ii. Med. Abt. / zentrum für rheumatologie
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Centro Internacional de Pesquisa; Reumatologia
City
Goiania
State/Province
GO
ZIP/Postal Code
74110010
Country
Brazil
Facility Name
Hospital das Clinicas - UFG;Reumatologia
City
Goiania
State/Province
GO
ZIP/Postal Code
74653-050
Country
Brazil
Facility Name
Centro Mineiro de Pesquisa - CMIP
City
Juiz de Fora
State/Province
MG
ZIP/Postal Code
36036-330
Country
Brazil
Facility Name
Centro de Estudos em Terapias Inovadoras - CETI
City
Curtiba
State/Province
PR
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital e Maternidade Celso Pierro - PUCCamp; Reumatologia
City
Campinas
State/Province
SP
ZIP/Postal Code
13059-900
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo - UNIFESP; Reumatologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04026-000
Country
Brazil
Facility Name
Centro Paulista de Investigacao Clinica - CEPIC
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Arthritis Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L7
Country
Canada
Facility Name
Laurel Medical Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3Y1
Country
Canada
Facility Name
Manitoba Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Nexus Clinical Research Centre
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
Facility Name
Dr. William G. Bensen Medicine Professional Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
K-W Musculoskeletal Research
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
Facility Name
St. Joseph'S Health Care Centre; Rheumatology
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Rheumatology Research Associates
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Niagara Peninsula Arthritis Centre
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2N 7E4
Country
Canada
Facility Name
Hopital Maisonneuve- Rosemont; Rheumatology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Institut de Rhumatologie de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Centre de Recherche Musculo-Squelettique
City
Trois-rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Saskatoon Osteoporosis Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
Facility Name
Centre Re Recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
10029
Country
China
Facility Name
General Hospital of Chinese PLA; Department of Hematology
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
The Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Facility Name
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Riesgo De Fractura; Rheumatology
City
Bogota
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin-Antioquia
Country
Colombia
Facility Name
Reumalab Sas; Rheumatology
City
Medellin
Country
Colombia
Facility Name
Sjællands Universitetshospital, Køge; Reumatologisk Afdeling
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Helsinki University Central Hospital; Rheumatology Clinic
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Kiljavan Lääketutkimus Oy
City
Hyvinkää
ZIP/Postal Code
05800
Country
Finland
Facility Name
CH Jean Rougier; Rhumato Reed Fonctionnelle
City
Cahors
ZIP/Postal Code
46005
Country
France
Facility Name
Fondation Hopital Saint Joseph; Rhumatologie
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
Hopital Lapeyronie; Immunologie Rhumatologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital emile muller; Rhumatologie
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
Hopital Porte Madeleine; Service de Rhumatologie
City
Orleans
ZIP/Postal Code
45032
Country
France
Facility Name
Ch Pitie Salpetriere; Rhumatologie
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Purpan; Rhumatologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Kerckhoff-Klinik; Rheumatologie&klin.Immunologie
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Rheuma-Zentrum Baden-Baden Gmbh; Klinik Für Innere Medizin-Rheumatologie
City
Baden-Baden
ZIP/Postal Code
76530
Country
Germany
Facility Name
Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Schlosspark Klinik; Abt. Rheumatologie
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w.
City
Erlangen
ZIP/Postal Code
91056
Country
Germany
Facility Name
Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Rheumapraxis PD Dr.med. Bernhard Heilig
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie
City
Herne
ZIP/Postal Code
44652
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Klinik der Uni zu Köln; Klinik für Innere Medizin
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Klinikum der Universität München; Bereich Pettenkoferstr.; Rheumaeinheit der medizinischen Klinik IV
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Rheumapraxis an der Hase
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
Evangelisches Fachkrankenhaus; Rheumaklinik
City
Ratingen
ZIP/Postal Code
40882
Country
Germany
Facility Name
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Laiko General Hospital; Hematology Clinic
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
University General Hospital of Larissa; Rheumatology Unit
City
Larissa
ZIP/Postal Code
411 10
Country
Greece
Facility Name
Clinica Medica Del Dr Eduardo Alfredo Samayoa
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Private Practice
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Reuma-Centro
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
QUEEN MARY HOSPITAL; Division of Rheumatology & Clinical Immunology
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
Facility Name
Pamela Youde Nethersole Eastern Hospital; Department of Medicine
City
Hong Kong
Country
Hong Kong
Facility Name
Tuen Mun Hospital; Medicine & Geriatrics
City
Tuen Mun
Country
Hong Kong
Facility Name
Budai Irgalmasrendi Kórház KHT. II. Reumatológia
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Markhot Ferenc Hospital; Dep. of Rheumatology
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Cork Uni Hospital; Dept of Rheumatology
City
Cork
Country
Ireland
Facility Name
Adelaide and Meath Hospital; Rheumatology Department
City
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
St.Vincent's University Hospital; Rheumatology Department
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Haemek Hospital; Rheumatology
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Barzilai; Rheumatology
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
Bnei Zion Medical Center; Rheumatology
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Hadassah University Hospital, Ein Karem; Rheumatology
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Hadassah Mount Scopus Hospital; Rheumatology
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
Facility Name
Meir Medical Center; Internal Dept A
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Chaim Sheba Medical Center; Rheumatology
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Chaim Sheba Medical Center; Interna Dept B
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Policlinico Universitario; Cattedra Di Reumatologia, Edificio 3
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Ortopedico Rizzoli; Unità di Reumatologia
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova; Reumatologia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
Campus Bio-Medico; Immunologia e Allergologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Policlinico Umberto I - Universita' La Sapienza ; Cattedra Di Reumatologia - Dept. Terapia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Università Degli Studi Di Genova - Dimi; Reumatologia
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Di Magenta Fornaroli; U.O. Di Reumatologia
City
Magenta
State/Province
Lombardia
ZIP/Postal Code
20013
Country
Italy
Facility Name
ASST FATEBENEFRATELLI SACCO; Reumatologia (Sacco)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
Ospedale S. Giovanni Bosco; S.C. A Direzione Uni Ria Di Immunologia Clinica
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10154
Country
Italy
Facility Name
Policlinico Universitario Di Cagliari
City
Monserrato
State/Province
Sardegna
ZIP/Postal Code
09042
Country
Italy
Facility Name
Clinic of Rheumatology; Clinical Centre Skopje
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
City
Culiacán Rosales
State/Province
Sinaloa
ZIP/Postal Code
80000
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia
City
Guadalajara
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
City
Mexicali
ZIP/Postal Code
21100
Country
Mexico
Facility Name
Unidad De Enfermedades; Cronico Degenerativas, SC.
City
Mexico
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Cliditer SA de CV
City
Miexico City
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Centro de Investigación Clínica de Morelia, S.C.; Reumatologia
City
Morelia
ZIP/Postal Code
58070
Country
Mexico
Facility Name
Hospital Universitario de Saltillo
City
Saltillo
ZIP/Postal Code
25000
Country
Mexico
Facility Name
Unidad de Enfermedades Reumaticas y Cronicodegenerativas
City
Torreon
ZIP/Postal Code
27000
Country
Mexico
Facility Name
North Shore Hospital, STAR Unit; Rheumatology Department
City
Auckland
Country
New Zealand
Facility Name
Waikato Hospital; Rheumatology Outpatients
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Timaru Hospital
City
Timaru
ZIP/Postal Code
7910
Country
New Zealand
Facility Name
Centro de Infusion Marbella; Consultorios Royal Center Num 214
City
Panama City
ZIP/Postal Code
32400
Country
Panama
Facility Name
Centro especializado de rehabilitacion fisica y del dolor cerfid - unidad de inv. En reumatologia
City
Lima
ZIP/Postal Code
LIMA 14
Country
Peru
Facility Name
Abk Reuma Srl- Medicentro
City
Lima
ZIP/Postal Code
Lima 21
Country
Peru
Facility Name
Centro de Investigaciones Medicas/Hospital Maria Auxiliadora
City
San Juan de Miraflores
ZIP/Postal Code
15801
Country
Peru
Facility Name
Philippine General Hospital; Rheumatology
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Jose Reyes Memorial Medical Center
City
Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
Uni of Santo Tomas Hospital; Rheumatology
City
Manila
ZIP/Postal Code
1015
Country
Philippines
Facility Name
Szpital Specjalistyczny Nr 1; Oddzial Reumatologii I Rehabilitacji
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Wojewodzki Szpital Zespolony; Oddzial Reumatologii
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
NZOZ REUMED Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Medyczne Centrum Hetmanska; Indywidualna Specjalistyczna Praktyka Lekarska
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Instytut Reumatologii im. Prof. Dr hab. Eleonory Reicher; Oddzial Wczesnej Diagnostyki Stawow
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
HUC; Servico de Reumatologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital de Santa Maria; Servico de Reumatologia
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital de Sao Joao; Servico de Reumatologia
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Ponce School of Medicine; Caimed Center
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
FSBI "National medico-surgical Centre n.a. N.I. Pirogov" of the Ministry of Healthcare
City
Moscow
ZIP/Postal Code
105203
Country
Russian Federation
Facility Name
FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
SBIH of Moscow "City clinical hospital #1 n.a. N.I. Pirogov" of Moscow Healthcare Department
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
SBIH of Moscow "City Clinical Hospital #20 of Moscow Healthcare Department"
City
Moscow
ZIP/Postal Code
129327
Country
Russian Federation
Facility Name
Ryazan State Medical University Named after I.P.Pavlov
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Facility Name
SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF
City
Saint-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
State institution of healthcare "Regional hospital for war veterans"
City
Saratov
ZIP/Postal Code
410002
Country
Russian Federation
Facility Name
State Institution of Healthcare of Tula Region "Tula Regional Clinical Hospital"
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
Facility Name
State Institution of Healthcare of Yaroslavl Region Clinical Hospital #8
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
National University Hospital; Dept of Medicine
City
Singapore
ZIP/Postal Code
117599
Country
Singapore
Facility Name
Netcare Private Hospital
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
St Augustines Hospital; Rheumatology
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Greenacres Hospital
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Clinical Research Unit
City
Pretoria
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Winelands Research Centre
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
Facility Name
Hospital Univ. Central de Asturias; Servicio de Reumatologia
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital de Merida ;Servicio de Reumatologia
City
Merida
State/Province
Badajoz
ZIP/Postal Code
06800
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Reumatologia
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Infanta Sofia; Servicio de Reumatologia
City
San Sebastian de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Reumatologia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital General Universitario de Guadalajara; Servicio de Reumatologia
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Hospital Universitario de la Princesa; Servicio de Reumatologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Reumatologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Univ. Nuestra Señora de Valme; Servicio de Reumatologia
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Karolinska University Hospital, Huddinge; Rheumatology
City
Huddinge
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Karolinska Sjukhuset; Reumatologkliniken D2-1
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Chulalongkorn Hospital; Division of Rheumatology - Medicine
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Phramongkutklao Hospital; Dept. of Medicine, Rheumatology
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ramathibodi Hospital, Mahidol Uni ; Allergy, Immunology & Rheumatology, Dept of Medicine
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Internal Medicine, Division of Rheumatology
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Iu Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali; Romatoloji Bilim Dali
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Addenbrooke'S Hospital; Rheumatology Research Unit
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Cannock Chase Hospital; Rheumatology
City
Cannock
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Russells Hall Hospital; Rheumatology Department
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Maidstone Hospital; Dept of Rheumatology
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Trafford General Hospital; Rheumatology
City
Manchester
ZIP/Postal Code
M41 5SL
Country
United Kingdom
Facility Name
Royal Victoria Infirmary; Clinical Research Facility
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
North Tyneside General Hospital
City
North Shields
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital; Rheumatology
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Haywood Hospital; Staffordshire Rheumatology Centre
City
Stoke-on-trent
ZIP/Postal Code
ST6 7AG
Country
United Kingdom
Facility Name
Torbay Hospital; Dept of Rhematology
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Arrowe Park Hospital; Rheumatology Dept
City
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28389552
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.
Results Reference
derived
PubMed Identifier
26511996
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.
Results Reference
derived

Learn more about this trial

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

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