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)

PHASE3TerminatedINTERVENTIONAL
Enrollment

836

Participants

Timeline

Start Date

May 15, 2007

Primary Completion Date

January 21, 2010

Study Completion Date

May 14, 2018

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Leflunomide

Oral repeating dose

DRUG

Methotrexate

Oral or parenteral repeating dose

DRUG

Ocrelizumab

Intravenous repeating dose (200mg)

DRUG

Ocrelizumab

Intravenous repeating dose (500mg)

DRUG

Placebo

Intravenous repeating dose

Trial Locations (266)

11

Clinica San Felipe; Consultorio de Reumatología, Lima

Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología, Lima

1000

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

1011

CHUV; Hôpital orthopédique, Rhumatologie, Lausanne

1020

CHU Brugmann (Victor Horta), Brussels

1023

Orszagos Reumatologiai Es Fizioterapias Intezet, Budapest

1027

Budai Irgalmasrendi Kórház KHT. II. Reumatológia, Budapest

2170

ZNA Jan Palfijn, Merksem

3000

UZ Leuven Gasthuisberg, Leuven

4032

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

4102

Princess Alexandra Hospital; Rheumatology, Woolloongabba

4558

Sunshine Coast Rheumatology Research Unit, Maroochydore

6000

CHU de Charleroi, Charleroi

GHdC Site Saint-Joseph, Gilly (Charleroi)

6008

Royal Perth Hospital; Rheumatology, Shenton Park

7910

Timaru Hospital, Timaru

8000

AZ Sint Jan, Bruges

8091

Universitätsspital Zürich; Klinik für Rheumatologie, Zurich

9000

UZ Gent, Ghent

9700

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

11201

Arthritis & Osteoporosis Center, Brooklyn

11407

Hospital de Jerez de la Frontera; Servicio de Reumatologia, Jerez de la Frontera

11576

Andrew Porges Pc, Roslyn

11787

Rheumatology Associates of Long Island, Smithtown

12206

The Center of Rheumatology, Albany

13285

Fondation Hopital Saint Joseph; Rhumatologie, Marseille

14059

Schlosspark Klinik; Abt. Rheumatologie, Berlin

14618

Aair Research Center, Rochester

14760

Southern Tier Arthritis & Rheumatism, Olean

15006

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

15090

Advanced Rheumatology & Arthritis Research Center, Wexford

16132

Università Degli Studi Di Genova - Dimi; Reumatologia, Genoa

16508

Arthritis Associates, Erie

Rheumatology Associates of NW Pa, Erie

18015

East Penn Rheumatology Associates, Pc, Bethlehem

19002

Hospital General Universitario de Guadalajara; Servicio de Reumatologia, Guadalajara

19152

Arthritis Group, Philadelphia

19610

Clinical Research Center of Reading, Wyomissing

19713

Javed Rheumatology Associates, Inc., Newark

19958

Rheumatolgy Consultants of Deleware, Lewes

20902

Center For Rheumatology & Bone Research, Wheaton

21100

Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel, Mexicali

21224

Johns Hopkins University; Department of Rheumatology, Baltimore

22205

Arthritis Clinic of Northern Virginia, Arlington

23507

Sentara Medical Group, Norfolk

27100

Irccs Policlinico San Matteo; Reumatologia Adulti, Pavia

27834

Physicians East Pa, Greenville

28012

Arthritis Associates, Belmont

28041

Hospital Universitario 12 de Octubre; Servicio de Reumatologia, Madrid

28209

Metrolina Medical Research, Charlotte

28210

Carolina Bone & Joint P.A., Charlotte

28602

Unifour Medical Research Associates, Hickory Grove

28803

Asheville Arthritis & Osteoporosis Center, PA, Asheville

29303

Spartanburg Medical Research, Spartanburg

29406

Low Country Research Center, Charleston

29425

Medical Uni of South Carolina, North Charleston

29644

Palmetto Clinical Trial Services, LLC, Fountain Inn

30041

Csi Research, Inc., Cumming

30060

Marietta Rheumatology Associates, Pc, Marietta

30342

Atlanta Center For Clinical Research., Atlanta

30625

Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie, Hanover

32216

Jacksonville Center For Clinical Research, Jacksonville

32400

Centro de Infusion Marbella; Consultorios Royal Center Num 214, Panama City

33006

Hospital Univ. Central de Asturias; Servicio de Reumatologia, Oviedo

33143

Center For Arthritis; Research Dept, South Miami

33180

Arthritis & Rheumatism; Disease Specialities, Aventura

33540

Florida Medical Center, Zephyrhills

33609

SW Florida Clinical Research, Tampa

33612

Tampa General Hospital; Rheumatology Research Dept, Tampa

33614

Burnette & Silverfield, MDS, Tampa

34239

Sarasota Arthritis Center; Research Dept, Sarasota

34295

Hopital Lapeyronie; Immunologie Rhumatologie, Montpellier

34684

Arthritis Center Palm Harbor, Palm Harbor

Arthritis Rsrch of Florida, Inc., Palm Harbor

35205

Rheumatology Associates, Birmingham

35392

Internistisches Praxiszentrum Am Krankenhaus Balserische Stiftung; Innere Medizin / Rheumatologie, Giessen

35801

Rheumatology Associates of North Alabama, Huntsville

36207

Pinnacle Research Group; Llc, Central, Anniston

37007

Hospital Clinico Universitario de Salamanca; Servicio de Reumatologia, Salamanca

37909

Rheumatology Consultants, Knoxville

38104

Arthritis Group, Memphis

38119

Ramesh Gupta - PP, Memphis

38305

West Tennessee Research Institute, Jackson

38802

North Mississippi Medical Ctr; Internal Medicine Associates, Tupelo

39232

Jackson Arthritis Clinic, Flowood

39300

Hospital Sierrallana; Servicio de Reumatologia, Torrelavega

40202

Kentuckiana Center For Better Bone & Joint Healthx, Louisville

40515

Bluegrass Comm Research, Inc., Lexington

42100

Arcispedale Santa Maria Nuova; Reumatologia, Reggio Emilia

42701

Center For Arthritis & Osteoporosis, Elizabethtown

44106

University Hospitals Case Medical Center, Cleveland

44130

Paramount Medical Research, Middleburg Heights

44143

David Mandel Inc, Mayfield

44620

Unidad De Enfermedades; Cronico Degenerativas, SC., México

44650

Consultorio Privado Dr. Javier Orozco, Guadalajara

45219

Deaconess Arthritis Center; Rheumatic Disease Study Group, Cincinnati

45402

Stat Research, Inc, Dayton

46005

CH Jean Rougier; Rhumato Reed Fonctionnelle, Cahors

46227

Diagnostic Rheumatology & Research, Indianapolis

46321

Medical Specialists Clinical Research Center, Munster

47055

Klinik Duisburg; Klinik Für Rheumatologie, Duisburg

48013

Hospital de Basurto; Servicio de Reumatologia, Bilbao

48080

Office of Andrew Sulich, Md, Saint Clair Shores

48106

Clinsite;Research Division of Integrated Health Associates, Ann Arbor

48910

Fiechtner Research Inc, Lansing

49009

Rheumatology, P.C.; Medical Arts Building, Kalamazoo

49048

Borgess Research Institute, Kalamazoo

49074

Rheumapraxis an der Hase, Osnabrück

50924

Klinik der Uni zu Köln; Klinik für Innere Medizin, Cologne

52064

Praxis Dr. med. Reiner Kurthen, Aachen

52401

Physician'S Clinic of Iowa, Cedar Rapids

53217

Rheumatic Disease Center, Glendale

54605

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

55121

St. Paul Rheumatology, Eagan

55131

Uniklinik Mainz; I. Medizinische Klinik, Mainz

55416

Park Nicollet Inst. ; Rtrc, Minneapolis

55805

St Luke's Whiteside Research, Duluth

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

56100

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

58135

Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik, Hagen

58185

Uni Hospital Linkoeping; Dept. of Rheumatology, Linköping

58501

St. Alexius Medical Center; Arthritis Clinic, Bismarck

59037

Hopital B Roger Salengro; Rhumatologie, Lille

60053

Illinois Bone & Joint Inst., Morton Grove

60201

Evanston Northwestern Healthcare; Rheumatology, Evanston

60596

Endokrinologikum Frankfurt; Rheumatologie & Gynäkologie, Frankfurt

60637

Uni of Chicago, Chicago

61265

Quad City Rheumatology, Sc, Moline

62703

Springfield Clinic, Springfield

63031

David S Rosenberg, Florissant

63117

Clayton Medical Research, St Louis

63131

Physicians Group, LC DBA Rheumatology & Internal Medicine Associates, St Louis

63141

Arthritis Consultants, St Louis

65807

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

66160

Uni of Kansas Medical Center, Kansas City

68024

Hopital Louis Pasteur; Service De Medecine Interne et de Rhumatologie, Colmar

68114

Westroads Medical Group, Omaha

69120

Rheumapraxis PD Dr.med. Bernhard Heilig, Heidelberg

UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V, Heidelberg

69121

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

70808

Baton Rouge Clinic, Amc, Baton Rouge

71913

CHI St. Vincent Medical Group Hot Springs, Hot Springs

72037

CH Du Mans; Rhumatologie, Le Mans

72205

Little Rock Diagnostic Clinic, Little Rock

73103

Health Research of Oklahoma, Llc, Oklahoma City

73104

Oklahoma Medical Research Foundation, Oklahoma City

74104

Oklahoma Center For Arthritis Therapy & Research, Tulsa

74135

Healthcare Research Consultants, Tulsa

75150

Southwest Rheumatology, Mesquite

75185

Akademiska sjukhuset, Reumatologkliniken, Uppsala

75231

Arthritis Care and Research Centre, Dallas

Metroplex Clinical Research, Dallas

75246

Arthritis Centers of Texas, Dallas

75390

Uni of Texas Southwestern Medical Center; Internal Medicine, Dallas

75679

Hopital Cochin; Rhumatologie A, Paris

Hopital Cochin; Rhumatologie B, Paris

76233

Hopital De Bois Guillaume; Rhumatologie, Bois-Guillaume

77479

Texas Research Center, Sugar Land

78217

Radiant Research, San Antonio

Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases, San Antonio

78705

Austin Rheumatology Research, Austin

Walter F. Chase, Md, Pa, Austin

79106

Aamr Research Clinic, Amarillo

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

79124

Amarillo Center For Clinical Research, Amarillo

79424

Arthritis & Osteoporosis Associates, LLP, Lubbock

80045

University of Colorado Cancer Center, Aurora

80336

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

80920

Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs, Colorado Springs

83642

Idaho Arthritis Center, Meridian

83702

Intermountain Orthopaedics, Boise

83814

Coeur D'Alene Arthritis Clinic, Coeur d'Alene

84132

Uni of Utah Medical Center, Salt Lake City

85000

Clinica San Jose Obregon; Rheumatology, Obregón

85202

Arizona Arthritis & Rheumatology Research, Pllc, Mesa

85208

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

85704

Catalina Pointe Clinical Research, Inc., Tucson

85724

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

90033

Uni of Southern California School of Medicine, Los Angeles

90045

Pacific Arthritis Care Center, Los Angeles

90505

Arthritis Treatment Center of South Bay, Torrance

90720

Valerius Medical Group & Research Ctr of Greater Long Beach, Los Alamitos

90808

Private Practice, Long Beach

92037

Allergy & Rheumatology Centre, La Jolla

92093

Ucsd, Dept of Medicine; Rheumatology, San Diego

92108

San Diego Arthritis Med Clnc, San Diego

94304

Stanford Uni Medical Center; Divison of Rheumatology, Palo Alto

94578

East Bay Rheumatology, San Leandro

97035

Portland Rheumatology Clinic Llc, Lake Oswego

97080

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

97213

Providence Arthritis Center, Portland

97401

Pro Research, Eugene

97701

Bend Memorial Clinic, Bend

98104

Seattle Rheumatology Associates, Seattle

98405

Office of George Krick, Md, Tacoma

Tacoma Center For Arthritis Research, Tacoma

98664

Vancouver Clinic; Research Dept, Vancouver

98902

Clinical Trials Northwest, Yakima

99204

Arthritis Northwest, Spokane, Spokane

128500

Revmatologicky Ustav, Prague

4428164

Meir Medical Center; Heamatology Dept, Kfar Saba

4941492

Beilinson Medical Center; Rheumatology, Petah Tikva

6093000

Assaf Harofe; Dept of Medicine B, Beer Yaakov

6423906

Sourasky / Ichilov Hospital; Rheumatology, Tel Aviv

8410101

Soroka Medical Center; Reumatology, Beersheba

74110010

Centro Internacional de Pesquisa; Reumatologia, Goiânia

06510

Arthritis & Osteoporosis Center P.C., Camden

06611

New England Research Associates, Trumbull

46202-5149

Iu Outpatient Clinical Research Facility, Indianapolis

01610

Clinical Pharmacology Study Group, Worcester

03820

Seacoast Arthritis and Osteoporosis Center, Dover

03060

Nashua Rheumatology - Foundation Medical Partners, Nashua

08035

Mark Fisher Md, Facr, Llc, Haddon Heights

08043

Arthritis Rheumatic & Back Disease Associates, Voorhees Township

75231-4406

Arthritis Care & Diagnostic Center, Dallas

C1015ABO

Organizacion Medica de Investigacion, Buenos Aires

C1428DQG

Inst. de Rehabilitacion Psicofisica; Reumathology, Buenos Aires

B1878DVB

CER Instituto Médico; REUMATOLOGÍA, San Juan Bautista

80030-110

Centro de Estudos em Terapias Inovadoras - CETI, Curtiba

21941-590

Hospital Universitario Clementino Fraga Filho - UFRJ; Reumatologia, Rio de Janeiro

13083-888

Hospital das Clinicas - UNICAMP, Campinas

04027-000

Hospital Abreu Sodre - AACD;Pesquisa Clinica, São Paulo

T6G 2S2

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

V5Z 1L7

Arthritis Research Centre, Vancouver

R3A 1M3

Manitoba Clinic, Winnipeg

L7R 1E2

Wharton Medical Clinic; Burlington, Burlington

L8N 2B6

Mac Research Inc., Hamilton

N2M 5N6

K-W Musculoskeletal Research, Kitchener

N6A 4V2

St. Joseph'S Health Care Centre; Rheumatology, London

L5M 2V8

Credit Valley, Rheumatology, Mississauga

K1H 7W9

The Ottawa Hospital - Riverside Campus; the Arthritis Centre, Ottawa

M5T 2S8

University Health Network; Toronto Western Hospital, Toronto

H1T 2M4

Hopital Maisonneuve- Rosemont; Rheumatology, Montreal

H2L 1S6

Institut de Rhumatologie de Montreal, Montreal

H3Z 2Z3

Montreal Rheumatic Disease Centre, Montreal

G1V 3M7

Groupe de Recherche En Rhumatologie Et Maladies Osseuses, Québec

G8Z 1Y2

Clin. de Rhumatologie, Trois-Rivières

S7N 0W8

Royal Uni Hospital; Medicine Dept, Saskatoon

06202

Hopital de L'Archet; Rhumatologie, Nice

037-0053

Seihoku Chuoh Hospital; Department Of Rheumatology, Aomori

807-8555

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

810-8563

National Hospital Organization Kyushu Medical Center; Rheumatology and Internal Medicine, Fukuoka

739-0002

Higashihiroshima Memorial Hospital; Rheumatology, Internal Medicine, Hiroshima

060-8648

Hokkaido Uni Hospital; Second Department of Internal Medicine, Hokkaido

673-1462

Matsubara Mayflower Hospital; Rheumatology, Hyōgo

857-1195

Sasebo Chuo Hospital ; Internal Medicine, Nagasaki

586-8521

Osaka Minami Medical Center; Rheumatoid Arthritis, Osaka

350-0495

Saitama Medical University Hospital ; Rheumatology and Applied Immunology, Saitama

350-0844

Saitama Medical Center/School; Rheumatology, Clinical immunology, Saitama

430-8558

Seirei Hamamatsu General Hospital; Rheumatology, Shizuoka

329-0498

Jichi Medical School Hospital; Rheumatology and Clinical Immunology, Tochigi

113-8519

Tokyo Medical & Dental University; Medicine & Rheumatology, Tokyo

162-0054

Tokyo Women's Medical University, Tokyo

1105 AZ

Academisch Medisch Centrum; Division of Clinical Immunology & Rheumatology, Amsterdam

5631 BM

Maxima Medisch Centrum; Rheumatology, Eindhoven

Unknown

Hospital Alberto Sabogal Sologuren; Remautology, Callao

85-168

Szpital Uniwersytecki; nr 2 im. Dr J. Biziela, Bydgoszcz

82-300

Wojewodzki Szpital Zespolony; Oddzial Reumatologii, Elblag

71-252

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

921 01

Narodny Ustav Reumatickych Chorob - 34479; Rheumatology, Piešťany

08208

Corporacio Sanitaria Parc Tauli; Servicio de Reumatologia, Sabadell

06080

Hospital Universitario Infanta Cristina; Servicio de Reumatologia, Badajoz

08036

Hospital Clinic i Provincial; Servicio de Reumatologia, Barcelona

08907

Hospital Universitari de Bellvitge; Servicio de Reumatologia, Barcelona

06006

Complejo Asistencial Universitario de Burgos; Servicio de Reumatología, Burgos

00833

Chang Gung Medical Foundation - Kaohsiung; Rheumatology, Kaohsiung City

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Genentech, Inc.

INDUSTRY