Clinical trial NCT00476996: A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)
Official title: A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: RA
SCRIPT
anti-CD20
CD20
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Roche Pharma AG
First posted: 2007-05-22
Enrollment: 836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥ 18 years of age
* Rheumatoid arthritis for at least 3 months
* Inadequate response to previous or current treatment with at least one anti-TNF-alpha agent
* Receiving either leflunomide or methotrexate for ≥ 12 weeks, with a stable dose for the last 4 weeks
* Swollen joint count (SJC) ≥ 4 (66 joint count) and tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline.
* CRP ≥ 0.6 mg/dL using a high-sensitivity assay.
* Positive rheumatoid factor or positive anti-CCP antibody or both.

Exclusion Criteria:

* Rheumatic autoimmune disease or inflammatory joint disease, other than RA
* Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline

Primary outcomes:
measure: Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses
timeFrame: Weeks 24 and 48
Secondary outcomes:
measure: Percentage of Participants With a Major Clinical Response
timeFrame: Week 48
measure: Percentage of Participants Achieving Disease Activity Score (DAS28) Remission
timeFrame: Weeks 24 and 48
measure: Change in DAS28 From Baseline
timeFrame: Weeks 24 and 48
measure: Percentage of Participants With EULAR Response Rates of Good/ Moderate
timeFrame: Weeks 24 and 48
measure: Percentage of Participants Achieving an ACR50 Response
timeFrame: Weeks 24 and 48
measure: Percentage of Participants Achieving an ACR70 Response
timeFrame: Weeks 24 and 48
measure: Percentage of Participants With a Reduction in the HAQ-DI Score
timeFrame: Weeks 24 and 48
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group; Llc, Central
state: Alabama
city: Birmingham
country: United States
facility: Rheumatology Associates
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama
state: Alabama
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, Pllc
state: Arizona
city: Mesa
country: United States
facility: Arthrocare, Arthritis Care and Research, P.C.
state: Arizona
city: Tucson
country: United States
facility: Catalina Pointe Clinical Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Uni of Arizona Health Science Center; Dept of Rheumatology/Immunology
state: Arizona
city: Hot Springs
country: United States
facility: CHI St. Vincent Medical Group Hot Springs
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Diagnostic Clinic
state: Arkansas
city: La Jolla
country: United States
facility: Allergy & Rheumatology Centre
state: California
city: Long Beach
country: United States
facility: Private Practice
state: California
city: Los Alamitos
country: United States
facility: Valerius Medical Group & Research Ctr of Greater Long Beach
state: California
city: Los Angeles
country: United States
facility: Uni of Southern California School of Medicine
state: California
city: Los Angeles
country: United States
facility: Pacific Arthritis Care Center
state: California
city: Palo Alto
country: United States
facility: Stanford Uni Medical Center; Divison of Rheumatology
state: California
city: San Diego
country: United States
facility: Ucsd, Dept of Medicine; Rheumatology
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Med Clnc
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology
state: California
city: Torrance
country: United States
facility: Arthritis Treatment Center of South Bay
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Colorado Springs
country: United States
facility: Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
state: Colorado
city: Camden
country: United States
facility: Arthritis & Osteoporosis Center P.C.
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates
state: Connecticut
city: Lewes
country: United States
facility: Rheumatolgy Consultants of Deleware
state: Delaware
city: Newark
country: United States
facility: Javed Rheumatology Associates, Inc.
state: Delaware
city: Aventura
country: United States
facility: Arthritis & Rheumatism; Disease Specialities
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center Palm Harbor
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Rsrch of Florida, Inc.
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Center; Research Dept
state: Florida
city: South Miami
country: United States
facility: Center For Arthritis; Research Dept
state: Florida
city: Tampa
country: United States
facility: SW Florida Clinical Research
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital; Rheumatology Research Dept
state: Florida
city: Tampa
country: United States
facility: Burnette & Silverfield, MDS
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center For Clinical Research.
state: Georgia
city: Cumming
country: United States
facility: Csi Research, Inc.
state: Georgia
city: Marietta
country: United States
facility: Marietta Rheumatology Associates, Pc
state: Georgia
city: Boise
country: United States
facility: Intermountain Orthopaedics
state: Idaho
city: Coeur d'Alene
country: United States
facility: Coeur D'Alene Arthritis Clinic
state: Idaho
city: Meridian
country: United States
facility: Idaho Arthritis Center
state: Idaho
city: Chicago
country: United States
facility: Uni of Chicago
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare; Rheumatology
state: Illinois
city: Moline
country: United States
facility: Quad City Rheumatology, Sc
state: Illinois
city: Morton Grove
country: United States
facility: Illinois Bone & Joint Inst.
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Indianapolis
country: United States
facility: Iu Outpatient Clinical Research Facility
state: Indiana
city: Indianapolis
country: United States
facility: Diagnostic Rheumatology & Research
state: Indiana
city: Munster
country: United States
facility: Medical Specialists Clinical Research Center
state: Indiana
city: Cedar Rapids
country: United States
facility: Physician'S Clinic of Iowa
state: Iowa
city: Kansas City
country: United States
facility: Uni of Kansas Medical Center
state: Kansas
city: Elizabethtown
country: United States
facility: Center For Arthritis & Osteoporosis
state: Kentucky
city: Lexington
country: United States
facility: Bluegrass Comm Research, Inc.
state: Kentucky
city: Louisville
country: United States
facility: Kentuckiana Center For Better Bone & Joint Healthx
state: Kentucky
city: Baton Rouge
country: United States
facility: Baton Rouge Clinic, Amc
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University; Department of Rheumatology
state: Maryland
city: Wheaton
country: United States
facility: Center For Rheumatology & Bone Research
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Ann Arbor
country: United States
facility: Clinsite;Research Division of Integrated Health Associates
state: Michigan
city: Kalamazoo
country: United States
facility: Rheumatology, P.C.; Medical Arts Building
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Lansing
country: United States
facility: Fiechtner Research Inc
state: Michigan
city: Saint Clair Shores
country: United States
facility: Office of Andrew Sulich, Md
state: Michigan
city: Duluth
country: United States
facility: St Luke's Whiteside Research
state: Minnesota
city: Duluth
country: United States
facility: St. Mary'S Duluth Clinic Health System; Rheumatology Dept
state: Minnesota
city: Eagan
country: United States
facility: St. Paul Rheumatology
state: Minnesota
city: Minneapolis
country: United States
facility: Park Nicollet Inst. ; Rtrc
state: Minnesota
city: Flowood
country: United States
facility: Jackson Arthritis Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Ctr; Internal Medicine Associates
state: Mississippi
city: Florissant
country: United States
facility: David S Rosenberg
state: Missouri
city: Saint Louis
country: United States
facility: Clayton Medical Research
state: Missouri
city: Saint Louis
country: United States
facility: Physicians Group, LC DBA Rheumatology & Internal Medicine Associates
state: Missouri
city: Saint Louis
country: United States
facility: Arthritis Consultants
state: Missouri
city: Springfield
country: United States
facility: St. John'S Health System Inc.; St. John'S Medical Research
state: Missouri
city: Omaha
country: United States
facility: Westroads Medical Group
state: Nebraska
city: Dover
country: United States
facility: Seacoast Arthritis and Osteoporosis Center
state: New Hampshire
city: Nashua
country: United States
facility: Nashua Rheumatology - Foundation Medical Partners
state: New Hampshire
city: Haddon Heights
country: United States
facility: Mark Fisher Md, Facr, Llc
state: New Jersey
city: Voorhees
country: United States
facility: Arthritis Rheumatic & Back Disease Associates
state: New Jersey
city: Albany
country: United States
facility: The Center of Rheumatology
state: New York
city: Brooklyn
country: United States
facility: Arthritis & Osteoporosis Center
state: New York
city: Olean
country: United States
facility: Southern Tier Arthritis & Rheumatism
state: New York
city: Rochester
country: United States
facility: Aair Research Center
state: New York
city: Roslyn
country: United States
facility: Andrew Porges Pc
state: New York
city: Smithtown
country: United States
facility: Rheumatology Associates of Long Island
state: New York
city: Asheville
country: United States
facility: Asheville Arthritis & Osteoporosis Center, PA
state: North Carolina
city: Belmont
country: United States
facility: Arthritis Associates
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Bone & Joint P.A.
state: North Carolina
city: Greenville
country: United States
facility: Physicians East Pa
state: North Carolina
city: Bismarck
country: United States
facility: St. Alexius Medical Center; Arthritis Clinic
state: North Dakota
city: Cincinnati
country: United States
facility: Deaconess Arthritis Center; Rheumatic Disease Study Group
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Dayton
country: United States
facility: Stat Research, Inc
state: Ohio
city: Mayfield
country: United States
facility: David Mandel Inc
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma, Llc
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Center For Arthritis Therapy & Research
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Eugene
country: United States
facility: Pro Research
state: Oregon
city: Lake Oswego
country: United States
facility: Portland Rheumatology Clinic Llc
state: Oregon
city: Portland
country: United States
facility: Providence Arthritis Center
state: Oregon
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, Pc
state: Pennsylvania
city: Erie
country: United States
facility: Arthritis Associates
state: Pennsylvania
city: Erie
country: United States
facility: Rheumatology Associates of NW Pa
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arthritis Group
state: Pennsylvania
city: Wexford
country: United States
facility: Advanced Rheumatology & Arthritis Research Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Research Center
state: South Carolina
city: Fountain Inn
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Hickory Grove
country: United States
facility: Unifour Medical Research Associates
state: South Carolina
city: North Charleston
country: United States
facility: Medical Uni of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Knoxville
country: United States
facility: Rheumatology Consultants
state: Tennessee
city: Memphis
country: United States
facility: Arthritis Group
state: Tennessee
city: Memphis
country: United States
facility: Ramesh Gupta - PP
state: Tennessee
city: Amarillo
country: United States
facility: Aamr Research Clinic
state: Texas
city: Amarillo
country: United States
facility: Amarillo Center For Clinical Research
state: Texas
city: Austin
country: United States
facility: Austin Rheumatology Research
state: Texas
city: Austin
country: United States
facility: Walter F. Chase, Md, Pa
state: Texas
city: Dallas
country: United States
facility: Arthritis Care & Diagnostic Center
state: Texas
city: Dallas
country: United States
facility: Arthritis Care and Research Centre
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research
state: Texas
city: Dallas
country: United States
facility: Arthritis Centers of Texas
state: Texas
city: Dallas
country: United States
facility: Uni of Texas Southwestern Medical Center; Internal Medicine
state: Texas
city: Lubbock
country: United States
facility: Arthritis & Osteoporosis Associates, LLP
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology
state: Texas
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: San Antonio
country: United States
facility: Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases
state: Texas
city: Sugar Land
country: United States
facility: Texas Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Uni of Utah Medical Center
state: Utah
city: Arlington
country: United States
facility: Arthritis Clinic of Northern Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, Spokane
state: Washington
city: Tacoma
country: United States
facility: Office of George Krick, Md
state: Washington
city: Tacoma
country: United States
facility: Tacoma Center For Arthritis Research
state: Washington
city: Vancouver
country: United States
facility: Vancouver Clinic; Research Dept
state: Washington
city: Yakima
country: United States
facility: Clinical Trials Northwest
state: Washington
city: Glendale
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
city: Onalaska
country: United States
facility: Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion
city: Buenos Aires
country: Argentina
facility: Inst. de Rehabilitacion Psicofisica; Reumathology
city: Florencio Varela
country: Argentina
facility: CER Instituto Médico; REUMATOLOGÍA
city: Maroochydore
country: Australia
facility: Sunshine Coast Rheumatology Research Unit
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital; Rheumatology
state: Queensland
city: Shenton Park
country: Australia
facility: Royal Perth Hospital; Rheumatology
state: Western Australia
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Bruxelles
country: Belgium
facility: CHU Brugmann (Victor Horta)
city: Charleroi
country: Belgium
facility: CHU de Charleroi
city: Gent
country: Belgium
facility: UZ Gent
city: Gilly (Charleroi)
country: Belgium
facility: GHdC Site Saint-Joseph
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Goiania
country: Brazil
facility: Centro Internacional de Pesquisa; Reumatologia
state: GO
city: Curtiba
country: Brazil
facility: Centro de Estudos em Terapias Inovadoras - CETI
state: PR
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Clementino Fraga Filho - UFRJ; Reumatologia
state: RJ
city: Campinas
country: Brazil
facility: Hospital das Clinicas - UNICAMP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Abreu Sodre - AACD;Pesquisa Clinica
state: SP
city: Edmonton
country: Canada
facility: The Governors of the Uni of Alberta; Heritage Medical Research Centre
state: Alberta
city: Vancouver
country: Canada
facility: Arthritis Research Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic
state: Manitoba
city: Burlington
country: Canada
facility: Wharton Medical Clinic; Burlington
state: Ontario
city: Hamilton
country: Canada
facility: Mac Research Inc.
state: Ontario
city: Kitchener
country: Canada
facility: K-W Musculoskeletal Research
state: Ontario
city: London
country: Canada
facility: St. Joseph'S Health Care Centre; Rheumatology
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley, Rheumatology
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Riverside Campus; the Arthritis Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network; Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve- Rosemont; Rheumatology
state: Quebec
city: Montreal
country: Canada
facility: Institut de Rhumatologie de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Montreal Rheumatic Disease Centre
state: Quebec
city: Quebec City
country: Canada
facility: Groupe de Recherche En Rhumatologie Et Maladies Osseuses
state: Quebec
city: Trois-rivieres
country: Canada
facility: Clin. de Rhumatologie
state: Quebec
city: Saskatoon
country: Canada
facility: Royal Uni Hospital; Medicine Dept
state: Saskatchewan
city: Prague
country: Czechia
facility: Revmatologicky Ustav
city: Bois Guillaume
country: France
facility: Hopital De Bois Guillaume; Rhumatologie
city: Cahors
country: France
facility: CH Jean Rougier; Rhumato Reed Fonctionnelle
city: Colmar
country: France
facility: Hopital Louis Pasteur; Service De Medecine Interne et de Rhumatologie
city: Le Mans
country: France
facility: CH Du Mans; Rhumatologie
city: Lille
country: France
facility: Hopital B Roger Salengro; Rhumatologie
city: Marseille
country: France
facility: Fondation Hopital Saint Joseph; Rhumatologie
city: Montpellier
country: France
facility: Hopital Lapeyronie; Immunologie Rhumatologie
city: Nice
country: France
facility: Hopital de L'Archet; Rhumatologie
city: Paris
country: France
facility: Hopital Cochin; Rhumatologie A
city: Paris
country: France
facility: Hopital Cochin; Rhumatologie B
city: Aachen
country: Germany
facility: Praxis Dr. med. Reiner Kurthen
city: Berlin
country: Germany
facility: Schlosspark Klinik; Abt. Rheumatologie
city: Duisburg
country: Germany
facility: Klinik Duisburg; Klinik Für Rheumatologie
city: Frankfurt
country: Germany
facility: Endokrinologikum Frankfurt; Rheumatologie & Gynäkologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie
city: Giessen
country: Germany
facility: Internistisches Praxiszentrum Am Krankenhaus Balserische Stiftung; Innere Medizin / Rheumatologie
city: Hagen
country: Germany
facility: Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik
city: Hannover
country: Germany
facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie
city: Heidelberg
country: Germany
facility: Rheumapraxis PD Dr.med. Bernhard Heilig
city: Heidelberg
country: Germany
facility: UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V
city: Heidelberg
country: Germany
facility: Fachärzte für Innere Medizin - Rheumatologie - Dr. med. Ino Gao und Dr. med. Maria Anna Meier
city: Köln
country: Germany
facility: Klinik der Uni zu Köln; Klinik für Innere Medizin
city: Mainz
country: Germany
facility: Uniklinik Mainz; I. Medizinische Klinik
city: München
country: Germany
facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV
city: Osnabrück
country: Germany
facility: Rheumapraxis an der Hase
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
city: Budapest
country: Hungary
facility: Orszagos Reumatologiai Es Fizioterapias Intezet
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Kórház KHT. II. Reumatológia
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
city: Szombathely
country: Hungary
facility: Vas Megye Es Szombathely M.J.V. Markusovszky Korhaza
city: Beer Sheva
country: Israel
facility: Soroka Medical Center; Reumatology
city: Beer Yaakov
country: Israel
facility: Assaf Harofe; Dept of Medicine B
city: Kfar Saba
country: Israel
facility: Meir Medical Center; Heamatology Dept
city: Petach Tikva
country: Israel
facility: Beilinson Medical Center; Rheumatology
city: Tel Aviv
country: Israel
facility: Sourasky / Ichilov Hospital; Rheumatology
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova; Reumatologia
state: Emilia-Romagna
city: Genova
country: Italy
facility: Università Degli Studi Di Genova - Dimi; Reumatologia
state: Liguria
city: Pavia
country: Italy
facility: Irccs Policlinico San Matteo; Reumatologia Adulti
state: Lombardia
city: Pisa
country: Italy
facility: Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia
state: Toscana
city: Aomori
country: Japan
facility: Seihoku Chuoh Hospital; Department Of Rheumatology
city: Fukuoka
country: Japan
facility: Univ. of Occupational and Environmental Health; Rheumatology, Clinical Immunology and Medicine
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center; Rheumatology and Internal Medicine
city: Hiroshima
country: Japan
facility: Higashihiroshima Memorial Hospital; Rheumatology, Internal Medicine
city: Hokkaido
country: Japan
facility: Hokkaido Uni Hospital; Second Department of Internal Medicine
city: Hyogo
country: Japan
facility: Matsubara Mayflower Hospital; Rheumatology
city: Nagasaki
country: Japan
facility: Sasebo Chuo Hospital ; Internal Medicine
city: Osaka
country: Japan
facility: Osaka Minami Medical Center; Rheumatoid Arthritis
city: Saitama
country: Japan
facility: Saitama Medical University Hospital ; Rheumatology and Applied Immunology
city: Saitama
country: Japan
facility: Saitama Medical Center/School; Rheumatology, Clinical immunology
city: Shizuoka
country: Japan
facility: Seirei Hamamatsu General Hospital; Rheumatology
city: Tochigi
country: Japan
facility: Jichi Medical School Hospital; Rheumatology and Clinical Immunology
city: Tokyo
country: Japan
facility: Tokyo Medical & Dental University; Medicine & Rheumatology
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
city: Guadalajara
country: Mexico
facility: Consultorio Privado Dr. Javier Orozco
city: Mexicali
country: Mexico
facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
city: Mexico
country: Mexico
facility: Unidad De Enfermedades; Cronico Degenerativas, SC.
city: Obregon
country: Mexico
facility: Clinica San Jose Obregon; Rheumatology
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum; Division of Clinical Immunology & Rheumatology
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum; Rheumatology
city: Timaru
country: New Zealand
facility: Timaru Hospital
city: Panama City
country: Panama
facility: Centro de Infusion Marbella; Consultorios Royal Center Num 214
city: Callao
country: Peru
facility: Hospital Alberto Sabogal Sologuren; Remautology
city: Lima
country: Peru
facility: Clinica San Felipe; Consultorio de Reumatología
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony; Oddzial Reumatologii
city: Szczecin
country: Poland
facility: Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Piestany
country: Slovakia
facility: Narodny Ustav Reumatickych Chorob - 34479; Rheumatology
city: Ljubljana
country: Slovenia
facility: Bolnica dr. Petra Drzaja, Klinicni center Ljubljana; Klinicni oddelek za revmatologijo
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; Servicio de Reumatologia
state: Asturias
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Reumatologia
state: Barcelona
city: Jerez de La Frontera
country: Spain
facility: Hospital de Jerez de la Frontera; Servicio de Reumatologia
state: Cadiz
city: Torrelavega
country: Spain
facility: Hospital Sierrallana; Servicio de Reumatologia
state: Cantabria
city: La Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Reumatologia
state: LA Coruña
city: Bilbao
country: Spain
facility: Hospital de Basurto; Servicio de Reumatologia
state: Vizcaya
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina; Servicio de Reumatologia
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial; Servicio de Reumatologia
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge; Servicio de Reumatologia
city: Burgos
country: Spain
facility: Complejo Asistencial Universitario de Burgos; Servicio de Reumatología
city: Guadalajara
country: Spain
facility: Hospital General Universitario de Guadalajara; Servicio de Reumatologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Reumatologia
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca; Servicio de Reumatologia
city: Linkoeping
country: Sweden
facility: Uni Hospital Linkoeping; Dept. of Rheumatology
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Reumatologkliniken
city: Lausanne
country: Switzerland
facility: CHUV; Hôpital orthopédique, Rhumatologie
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich; Klinik für Rheumatologie
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation - Kaohsiung; Rheumatology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Emery P, Rigby W, Tak PP, Dorner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.
citation: Tak PP, Mease PJ, Genovese MC, Kremer J, Haraoui B, Tanaka Y, Bingham CO 3rd, Ashrafzadeh A, Travers H, Safa-Leathers S, Kumar S, Dummer W. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight-week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum. 2012 Feb;64(2):360-70. doi: 10.1002/art.33353.