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)

NCT ID: NCT00476996

Last Updated: 2019-08-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

836 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-15

Study Completion Date

2018-05-14

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ocrelizumab 200 mg x 2 IV + Non-Biologic DMARD Therapy

Participants will receive 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD

Group Type EXPERIMENTAL

Leflunomide

Intervention Type DRUG

Oral repeating dose

Methotrexate

Intervention Type DRUG

Oral or parenteral repeating dose

Ocrelizumab

Intervention Type DRUG

Intravenous repeating dose (200mg)

Ocrelizumab 500 mg x 2 IV + Non-Biologic DMARD Therapy

Participants will receive 2 IV infusions of 500 mg of ocrelizumab, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD

Group Type EXPERIMENTAL

Leflunomide

Intervention Type DRUG

Oral repeating dose

Methotrexate

Intervention Type DRUG

Oral or parenteral repeating dose

Ocrelizumab

Intervention Type DRUG

Intravenous repeating dose (500mg)

Placebo x 2 IV + Non-Biologic DMARD Therapy

Participants will receive ocrelizumab matching placebo IV in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD

Group Type PLACEBO_COMPARATOR

Leflunomide

Intervention Type DRUG

Oral repeating dose

Methotrexate

Intervention Type DRUG

Oral or parenteral repeating dose

Placebo

Intervention Type DRUG

Intravenous repeating dose

Interventions

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Leflunomide

Oral repeating dose

Intervention Type DRUG

Methotrexate

Oral or parenteral repeating dose

Intervention Type DRUG

Ocrelizumab

Intravenous repeating dose (200mg)

Intervention Type DRUG

Ocrelizumab

Intravenous repeating dose (500mg)

Intervention Type DRUG

Placebo

Intravenous repeating dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Pinnacle Research Group; Llc, Central

Anniston, Alabama, United States

Site Status

Rheumatology Associates

Birmingham, Alabama, United States

Site Status

Rheumatology Associates of North Alabama

Huntsville, Alabama, United States

Site Status

Arizona Arthritis & Rheumatology Research, Pllc

Mesa, Arizona, United States

Site Status

Arthrocare, Arthritis Care and Research, P.C.

Mesa, Arizona, United States

Site Status

Catalina Pointe Clinical Research, Inc.

Tucson, Arizona, United States

Site Status

Uni of Arizona Health Science Center; Dept of Rheumatology/Immunology

Tucson, Arizona, United States

Site Status

CHI St. Vincent Medical Group Hot Springs

Hot Springs, Arkansas, United States

Site Status

Little Rock Diagnostic Clinic

Little Rock, Arkansas, United States

Site Status

Allergy & Rheumatology Centre

La Jolla, California, United States

Site Status

Private Practice

Long Beach, California, United States

Site Status

Valerius Medical Group & Research Ctr of Greater Long Beach

Los Alamitos, California, United States

Site Status

Uni of Southern California School of Medicine

Los Angeles, California, United States

Site Status

Pacific Arthritis Care Center

Los Angeles, California, United States

Site Status

Stanford Uni Medical Center; Divison of Rheumatology

Palo Alto, California, United States

Site Status

Ucsd, Dept of Medicine; Rheumatology

San Diego, California, United States

Site Status

San Diego Arthritis Med Clnc

San Diego, California, United States

Site Status

East Bay Rheumatology

San Leandro, California, United States

Site Status

Arthritis Treatment Center of South Bay

Torrance, California, United States

Site Status

University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status

Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

Colorado Springs, Colorado, United States

Site Status

Arthritis & Osteoporosis Center P.C.

Camden, Connecticut, United States

Site Status

New England Research Associates

Trumbull, Connecticut, United States

Site Status

Rheumatolgy Consultants of Deleware

Lewes, Delaware, United States

Site Status

Javed Rheumatology Associates, Inc.

Newark, Delaware, United States

Site Status

Arthritis & Rheumatism; Disease Specialities

Aventura, Florida, United States

Site Status

Jacksonville Center For Clinical Research

Jacksonville, Florida, United States

Site Status

Arthritis Center Palm Harbor

Palm Harbor, Florida, United States

Site Status

Arthritis Rsrch of Florida, Inc.

Palm Harbor, Florida, United States

Site Status

Sarasota Arthritis Center; Research Dept

Sarasota, Florida, United States

Site Status

Center For Arthritis; Research Dept

South Miami, Florida, United States

Site Status

SW Florida Clinical Research

Tampa, Florida, United States

Site Status

Tampa General Hospital; Rheumatology Research Dept

Tampa, Florida, United States

Site Status

Burnette & Silverfield, MDS

Tampa, Florida, United States

Site Status

Florida Medical Center

Zephyrhills, Florida, United States

Site Status

Atlanta Center For Clinical Research.

Atlanta, Georgia, United States

Site Status

Csi Research, Inc.

Cumming, Georgia, United States

Site Status

Marietta Rheumatology Associates, Pc

Marietta, Georgia, United States

Site Status

Intermountain Orthopaedics

Boise, Idaho, United States

Site Status

Coeur D'Alene Arthritis Clinic

Coeur d'Alene, Idaho, United States

Site Status

Idaho Arthritis Center

Meridian, Idaho, United States

Site Status

Uni of Chicago

Chicago, Illinois, United States

Site Status

Evanston Northwestern Healthcare; Rheumatology

Evanston, Illinois, United States

Site Status

Quad City Rheumatology, Sc

Moline, Illinois, United States

Site Status

Illinois Bone & Joint Inst.

Morton Grove, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Iu Outpatient Clinical Research Facility

Indianapolis, Indiana, United States

Site Status

Diagnostic Rheumatology & Research

Indianapolis, Indiana, United States

Site Status

Medical Specialists Clinical Research Center

Munster, Indiana, United States

Site Status

Physician'S Clinic of Iowa

Cedar Rapids, Iowa, United States

Site Status

Uni of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Center For Arthritis & Osteoporosis

Elizabethtown, Kentucky, United States

Site Status

Bluegrass Comm Research, Inc.

Lexington, Kentucky, United States

Site Status

Kentuckiana Center For Better Bone & Joint Healthx

Louisville, Kentucky, United States

Site Status

Baton Rouge Clinic, Amc

Baton Rouge, Louisiana, United States

Site Status

Johns Hopkins University; Department of Rheumatology

Baltimore, Maryland, United States

Site Status

Center For Rheumatology & Bone Research

Wheaton, Maryland, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Clinsite;Research Division of Integrated Health Associates

Ann Arbor, Michigan, United States

Site Status

Rheumatology, P.C.; Medical Arts Building

Kalamazoo, Michigan, United States

Site Status

Borgess Research Institute

Kalamazoo, Michigan, United States

Site Status

Fiechtner Research Inc

Lansing, Michigan, United States

Site Status

Office of Andrew Sulich, Md

Saint Clair Shores, Michigan, United States

Site Status

St Luke's Whiteside Research

Duluth, Minnesota, United States

Site Status

St. Mary'S Duluth Clinic Health System; Rheumatology Dept

Duluth, Minnesota, United States

Site Status

St. Paul Rheumatology

Eagan, Minnesota, United States

Site Status

Park Nicollet Inst. ; Rtrc

Minneapolis, Minnesota, United States

Site Status

Jackson Arthritis Clinic

Flowood, Mississippi, United States

Site Status

North Mississippi Medical Ctr; Internal Medicine Associates

Tupelo, Mississippi, United States

Site Status

David S Rosenberg

Florissant, Missouri, United States

Site Status

St. John'S Health System Inc.; St. John'S Medical Research

Springfield, Missouri, United States

Site Status

Clayton Medical Research

St Louis, Missouri, United States

Site Status

Physicians Group, LC DBA Rheumatology & Internal Medicine Associates

St Louis, Missouri, United States

Site Status

Arthritis Consultants

St Louis, Missouri, United States

Site Status

Westroads Medical Group

Omaha, Nebraska, United States

Site Status

Seacoast Arthritis and Osteoporosis Center

Dover, New Hampshire, United States

Site Status

Nashua Rheumatology - Foundation Medical Partners

Nashua, New Hampshire, United States

Site Status

Mark Fisher Md, Facr, Llc

Haddon Heights, New Jersey, United States

Site Status

Arthritis Rheumatic & Back Disease Associates

Voorhees Township, New Jersey, United States

Site Status

The Center of Rheumatology

Albany, New York, United States

Site Status

Arthritis & Osteoporosis Center

Brooklyn, New York, United States

Site Status

Southern Tier Arthritis & Rheumatism

Olean, New York, United States

Site Status

Aair Research Center

Rochester, New York, United States

Site Status

Andrew Porges Pc

Roslyn, New York, United States

Site Status

Rheumatology Associates of Long Island

Smithtown, New York, United States

Site Status

Asheville Arthritis & Osteoporosis Center, PA

Asheville, North Carolina, United States

Site Status

Arthritis Associates

Belmont, North Carolina, United States

Site Status

Metrolina Medical Research

Charlotte, North Carolina, United States

Site Status

Carolina Bone & Joint P.A.

Charlotte, North Carolina, United States

Site Status

Physicians East Pa

Greenville, North Carolina, United States

Site Status

St. Alexius Medical Center; Arthritis Clinic

Bismarck, North Dakota, United States

Site Status

Deaconess Arthritis Center; Rheumatic Disease Study Group

Cincinnati, Ohio, United States

Site Status

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Stat Research, Inc

Dayton, Ohio, United States

Site Status

David Mandel Inc

Mayfield, Ohio, United States

Site Status

Paramount Medical Research

Middleburg Heights, Ohio, United States

Site Status

Health Research of Oklahoma, Llc

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Center For Arthritis Therapy & Research

Tulsa, Oklahoma, United States

Site Status

Healthcare Research Consultants

Tulsa, Oklahoma, United States

Site Status

Bend Memorial Clinic

Bend, Oregon, United States

Site Status

Pro Research

Eugene, Oregon, United States

Site Status

Portland Rheumatology Clinic Llc

Lake Oswego, Oregon, United States

Site Status

Providence Arthritis Center

Portland, Oregon, United States

Site Status

East Penn Rheumatology Associates, Pc

Bethlehem, Pennsylvania, United States

Site Status

Arthritis Associates

Erie, Pennsylvania, United States

Site Status

Rheumatology Associates of NW Pa

Erie, Pennsylvania, United States

Site Status

Arthritis Group

Philadelphia, Pennsylvania, United States

Site Status

Advanced Rheumatology & Arthritis Research Center

Wexford, Pennsylvania, United States

Site Status

Clinical Research Center of Reading

Wyomissing, Pennsylvania, United States

Site Status

Low Country Research Center

Charleston, South Carolina, United States

Site Status

Palmetto Clinical Trial Services, LLC

Fountain Inn, South Carolina, United States

Site Status

Unifour Medical Research Associates

Hickory Grove, South Carolina, United States

Site Status

Medical Uni of South Carolina

North Charleston, South Carolina, United States

Site Status

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Site Status

West Tennessee Research Institute

Jackson, Tennessee, United States

Site Status

Rheumatology Consultants

Knoxville, Tennessee, United States

Site Status

Arthritis Group

Memphis, Tennessee, United States

Site Status

Ramesh Gupta - PP

Memphis, Tennessee, United States

Site Status

Aamr Research Clinic

Amarillo, Texas, United States

Site Status

Amarillo Center For Clinical Research

Amarillo, Texas, United States

Site Status

Austin Rheumatology Research

Austin, Texas, United States

Site Status

Walter F. Chase, Md, Pa

Austin, Texas, United States

Site Status

Arthritis Care & Diagnostic Center

Dallas, Texas, United States

Site Status

Arthritis Care and Research Centre

Dallas, Texas, United States

Site Status

Metroplex Clinical Research

Dallas, Texas, United States

Site Status

Arthritis Centers of Texas

Dallas, Texas, United States

Site Status

Uni of Texas Southwestern Medical Center; Internal Medicine

Dallas, Texas, United States

Site Status

Arthritis & Osteoporosis Associates, LLP

Lubbock, Texas, United States

Site Status

Southwest Rheumatology

Mesquite, Texas, United States

Site Status

Radiant Research

San Antonio, Texas, United States

Site Status

Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases

San Antonio, Texas, United States

Site Status

Texas Research Center

Sugar Land, Texas, United States

Site Status

Uni of Utah Medical Center

Salt Lake City, Utah, United States

Site Status

Arthritis Clinic of Northern Virginia

Arlington, Virginia, United States

Site Status

Sentara Medical Group

Norfolk, Virginia, United States

Site Status

Seattle Rheumatology Associates

Seattle, Washington, United States

Site Status

Arthritis Northwest, Spokane

Spokane, Washington, United States

Site Status

Office of George Krick, Md

Tacoma, Washington, United States

Site Status

Tacoma Center For Arthritis Research

Tacoma, Washington, United States

Site Status

Vancouver Clinic; Research Dept

Vancouver, Washington, United States

Site Status

Clinical Trials Northwest

Yakima, Washington, United States

Site Status

Rheumatic Disease Center

Glendale, Wisconsin, United States

Site Status

Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med

Onalaska, Wisconsin, United States

Site Status

Organizacion Medica de Investigacion

Buenos Aires, , Argentina

Site Status

Inst. de Rehabilitacion Psicofisica; Reumathology

Buenos Aires, , Argentina

Site Status

CER Instituto Médico; REUMATOLOGÍA

San Juan Bautista, , Argentina

Site Status

Sunshine Coast Rheumatology Research Unit

Maroochydore, Queensland, Australia

Site Status

Princess Alexandra Hospital; Rheumatology

Woolloongabba, Queensland, Australia

Site Status

Royal Perth Hospital; Rheumatology

Shenton Park, Western Australia, Australia

Site Status

AZ Sint Jan

Bruges, , Belgium

Site Status

CHU Brugmann (Victor Horta)

Brussels, , Belgium

Site Status

CHU de Charleroi

Charleroi, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

GHdC Site Saint-Joseph

Gilly (Charleroi), , Belgium

Site Status

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

ZNA Jan Palfijn

Merksem, , Belgium

Site Status

Centro Internacional de Pesquisa; Reumatologia

Goiânia, Goiás, Brazil

Site Status

Centro de Estudos em Terapias Inovadoras - CETI

Curtiba, Paraná, Brazil

Site Status

Hospital Universitario Clementino Fraga Filho - UFRJ; Reumatologia

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital das Clinicas - UNICAMP

Campinas, São Paulo, Brazil

Site Status

Hospital Abreu Sodre - AACD;Pesquisa Clinica

São Paulo, São Paulo, Brazil

Site Status

The Governors of the Uni of Alberta; Heritage Medical Research Centre

Edmonton, Alberta, Canada

Site Status

Arthritis Research Centre

Vancouver, British Columbia, Canada

Site Status

Manitoba Clinic

Winnipeg, Manitoba, Canada

Site Status

Wharton Medical Clinic; Burlington

Burlington, Ontario, Canada

Site Status

Mac Research Inc.

Hamilton, Ontario, Canada

Site Status

K-W Musculoskeletal Research

Kitchener, Ontario, Canada

Site Status

St. Joseph'S Health Care Centre; Rheumatology

London, Ontario, Canada

Site Status

Credit Valley, Rheumatology

Mississauga, Ontario, Canada

Site Status

The Ottawa Hospital - Riverside Campus; the Arthritis Centre

Ottawa, Ontario, Canada

Site Status

University Health Network; Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Hopital Maisonneuve- Rosemont; Rheumatology

Montreal, Quebec, Canada

Site Status

Institut de Rhumatologie de Montreal

Montreal, Quebec, Canada

Site Status

Montreal Rheumatic Disease Centre

Montreal, Quebec, Canada

Site Status

Groupe de Recherche En Rhumatologie Et Maladies Osseuses

Québec, Quebec, Canada

Site Status

Clin. de Rhumatologie

Trois-Rivières, Quebec, Canada

Site Status

Royal Uni Hospital; Medicine Dept

Saskatoon, Saskatchewan, Canada

Site Status

Revmatologicky Ustav

Prague, , Czechia

Site Status

Hopital De Bois Guillaume; Rhumatologie

Bois-Guillaume, , France

Site Status

CH Jean Rougier; Rhumato Reed Fonctionnelle

Cahors, , France

Site Status

Hopital Louis Pasteur; Service De Medecine Interne et de Rhumatologie

Colmar, , France

Site Status

CH Du Mans; Rhumatologie

Le Mans, , France

Site Status

Hopital B Roger Salengro; Rhumatologie

Lille, , France

Site Status

Fondation Hopital Saint Joseph; Rhumatologie

Marseille, , France

Site Status

Hopital Lapeyronie; Immunologie Rhumatologie

Montpellier, , France

Site Status

Hopital de L'Archet; Rhumatologie

Nice, , France

Site Status

Hopital Cochin; Rhumatologie A

Paris, , France

Site Status

Hopital Cochin; Rhumatologie B

Paris, , France

Site Status

Praxis Dr. med. Reiner Kurthen

Aachen, , Germany

Site Status

Schlosspark Klinik; Abt. Rheumatologie

Berlin, , Germany

Site Status

Klinik der Uni zu Köln; Klinik für Innere Medizin

Cologne, , Germany

Site Status

Klinik Duisburg; Klinik Für Rheumatologie

Duisburg, , Germany

Site Status

Endokrinologikum Frankfurt; Rheumatologie & Gynäkologie

Frankfurt, , Germany

Site Status

Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie

Freiburg im Breisgau, , Germany

Site Status

Internistisches Praxiszentrum Am Krankenhaus Balserische Stiftung; Innere Medizin / Rheumatologie

Giessen, , Germany

Site Status

Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik

Hagen, , Germany

Site Status

Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie

Hanover, , Germany

Site Status

Rheumapraxis PD Dr.med. Bernhard Heilig

Heidelberg, , Germany

Site Status

UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V

Heidelberg, , Germany

Site Status

Fachärzte für Innere Medizin - Rheumatologie - Dr. med. Ino Gao und Dr. med. Maria Anna Meier

Heidelberg, , Germany

Site Status

Uniklinik Mainz; I. Medizinische Klinik

Mainz, , Germany

Site Status

Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

München, , Germany

Site Status

Rheumapraxis an der Hase

Osnabrück, , Germany

Site Status

Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie

Würzburg, , Germany

Site Status

Orszagos Reumatologiai Es Fizioterapias Intezet

Budapest, , Hungary

Site Status

Budai Irgalmasrendi Kórház KHT. II. Reumatológia

Budapest, , Hungary

Site Status

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

Debrecen, , Hungary

Site Status

Vas Megye Es Szombathely M.J.V. Markusovszky Korhaza

Szombathely, , Hungary

Site Status

Assaf Harofe; Dept of Medicine B

Beer Yaakov, , Israel

Site Status

Soroka Medical Center; Reumatology

Beersheba, , Israel

Site Status

Meir Medical Center; Heamatology Dept

Kfar Saba, , Israel

Site Status

Beilinson Medical Center; Rheumatology

Petah Tikva, , Israel

Site Status

Sourasky / Ichilov Hospital; Rheumatology

Tel Aviv, , Israel

Site Status

Arcispedale Santa Maria Nuova; Reumatologia

Reggio Emilia, Emilia-Romagna, Italy

Site Status

Università Degli Studi Di Genova - Dimi; Reumatologia

Genoa, Liguria, Italy

Site Status

Irccs Policlinico San Matteo; Reumatologia Adulti

Pavia, Lombardy, Italy

Site Status

Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia

Pisa, Tuscany, Italy

Site Status

Seihoku Chuoh Hospital; Department Of Rheumatology

Aomori, , Japan

Site Status

Univ. of Occupational and Environmental Health; Rheumatology, Clinical Immunology and Medicine

Fukuoka, , Japan

Site Status

National Hospital Organization Kyushu Medical Center; Rheumatology and Internal Medicine

Fukuoka, , Japan

Site Status

Higashihiroshima Memorial Hospital; Rheumatology, Internal Medicine

Hiroshima, , Japan

Site Status

Hokkaido Uni Hospital; Second Department of Internal Medicine

Hokkaido, , Japan

Site Status

Matsubara Mayflower Hospital; Rheumatology

Hyōgo, , Japan

Site Status

Sasebo Chuo Hospital ; Internal Medicine

Nagasaki, , Japan

Site Status

Osaka Minami Medical Center; Rheumatoid Arthritis

Osaka, , Japan

Site Status

Saitama Medical University Hospital ; Rheumatology and Applied Immunology

Saitama, , Japan

Site Status

Saitama Medical Center/School; Rheumatology, Clinical immunology

Saitama, , Japan

Site Status

Seirei Hamamatsu General Hospital; Rheumatology

Shizuoka, , Japan

Site Status

Jichi Medical School Hospital; Rheumatology and Clinical Immunology

Tochigi, , Japan

Site Status

Tokyo Medical & Dental University; Medicine & Rheumatology

Tokyo, , Japan

Site Status

Tokyo Women's Medical University

Tokyo, , Japan

Site Status

Consultorio Privado Dr. Javier Orozco

Guadalajara, , Mexico

Site Status

Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

Mexicali, , Mexico

Site Status

Unidad De Enfermedades; Cronico Degenerativas, SC.

México, , Mexico

Site Status

Clinica San Jose Obregon; Rheumatology

Obregón, , Mexico

Site Status

Academisch Medisch Centrum; Division of Clinical Immunology & Rheumatology

Amsterdam, , Netherlands

Site Status

Maxima Medisch Centrum; Rheumatology

Eindhoven, , Netherlands

Site Status

Timaru Hospital

Timaru, , New Zealand

Site Status

Centro de Infusion Marbella; Consultorios Royal Center Num 214

Panama City, , Panama

Site Status

Hospital Alberto Sabogal Sologuren; Remautology

Callao, , Peru

Site Status

Clinica San Felipe; Consultorio de Reumatología

Lima, , Peru

Site Status

Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología

Lima, , Peru

Site Status

Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

Bydgoszcz, , Poland

Site Status

Wojewodzki Szpital Zespolony; Oddzial Reumatologii

Elblag, , Poland

Site Status

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

Szczecin, , Poland

Site Status

Narodny Ustav Reumatickych Chorob - 34479; Rheumatology

Piešťany, , Slovakia

Site Status

Bolnica dr. Petra Drzaja, Klinicni center Ljubljana; Klinicni oddelek za revmatologijo

Ljubljana, , Slovenia

Site Status

Corporacio Sanitaria Parc Tauli; Servicio de Reumatologia

Sabadell, Barcelona, Spain

Site Status

Hospital de Jerez de la Frontera; Servicio de Reumatologia

Jerez de la Frontera, Cadiz, Spain

Site Status

Hospital Sierrallana; Servicio de Reumatologia

Torrelavega, Cantabria, Spain

Site Status

Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Reumatologia

A Coruña, LA Coruña, Spain

Site Status

Hospital Univ. Central de Asturias; Servicio de Reumatologia

Oviedo, Principality of Asturias, Spain

Site Status

Hospital de Basurto; Servicio de Reumatologia

Bilbao, Vizcaya, Spain

Site Status

Hospital Universitario Infanta Cristina; Servicio de Reumatologia

Badajoz, , Spain

Site Status

Hospital Clinic i Provincial; Servicio de Reumatologia

Barcelona, , Spain

Site Status

Hospital Universitari de Bellvitge; Servicio de Reumatologia

Barcelona, , Spain

Site Status

Complejo Asistencial Universitario de Burgos; Servicio de Reumatología

Burgos, , Spain

Site Status

Hospital General Universitario de Guadalajara; Servicio de Reumatologia

Guadalajara, , Spain

Site Status

Hospital Universitario 12 de Octubre; Servicio de Reumatologia

Madrid, , Spain

Site Status

Hospital Clinico Universitario de Salamanca; Servicio de Reumatologia

Salamanca, , Spain

Site Status

Uni Hospital Linkoeping; Dept. of Rheumatology

Linköping, , Sweden

Site Status

Akademiska sjukhuset, Reumatologkliniken

Uppsala, , Sweden

Site Status

CHUV; Hôpital orthopédique, Rhumatologie

Lausanne, , Switzerland

Site Status

Universitätsspital Zürich; Klinik für Rheumatologie

Zurich, , Switzerland

Site Status

Chang Gung Medical Foundation - Kaohsiung; Rheumatology

Kaohsiung City, , Taiwan

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada Czechia France Germany Hungary Israel Italy Japan Mexico Netherlands New Zealand Panama Peru Poland Slovakia Slovenia Spain Sweden Switzerland Taiwan

References

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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.

Reference Type DERIVED
PMID: 24498318 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22389919 (View on PubMed)

Other Identifiers

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WA20495

Identifier Type: OTHER

Identifier Source: secondary_id

2006-005330-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACT3986g

Identifier Type: -

Identifier Source: org_study_id

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