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) (SCRIPT)

August 8, 2019 updated by: Genentech, Inc.

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

836

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1015ABO
        • Organizacion Medica de Investigacion
      • Buenos Aires, Argentina, C1428DQG
        • Inst. de Rehabilitacion Psicofisica; Reumathology
      • Florencio Varela, Argentina, B1878DVB
        • CER Instituto Médico; REUMATOLOGÍA
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Sunshine Coast Rheumatology Research Unit
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital; Rheumatology
    • Western Australia
      • Shenton Park, Western Australia, Australia, 6008
        • Royal Perth Hospital; Rheumatology
      • Brugge, Belgium, 8000
        • AZ Sint Jan
      • Bruxelles, Belgium, 1020
        • CHU Brugmann (Victor Horta)
      • Charleroi, Belgium, 6000
        • CHU de Charleroi
      • Gent, Belgium, 9000
        • UZ Gent
      • Gilly (Charleroi), Belgium, 6000
        • GHdC Site Saint-Joseph
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
      • Merksem, Belgium, 2170
        • ZNA Jan Palfijn
    • GO
      • Goiania, GO, Brazil, 74110010
        • Centro Internacional de Pesquisa; Reumatologia
    • PR
      • Curtiba, PR, Brazil, 80030-110
        • Centro de Estudos em Terapias Inovadoras - CETI
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-590
        • Hospital Universitario Clementino Fraga Filho - UFRJ; Reumatologia
    • SP
      • Campinas, SP, Brazil, 13083-888
        • Hospital das Clinicas - UNICAMP
      • Sao Paulo, SP, Brazil, 04027-000
        • Hospital Abreu Sodre - AACD;Pesquisa Clinica
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2S2
        • The Governors of the Uni of Alberta; Heritage Medical Research Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L7
        • Arthritis Research Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Manitoba Clinic
    • Ontario
      • Burlington, Ontario, Canada, L7R 1E2
        • Wharton Medical Clinic; Burlington
      • Hamilton, Ontario, Canada, L8N 2B6
        • MAC Research Inc.
      • Kitchener, Ontario, Canada, N2M 5N6
        • K-W Musculoskeletal Research
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph'S Health Care Centre; Rheumatology
      • Mississauga, Ontario, Canada, L5M 2V8
        • Credit Valley, Rheumatology
      • Ottawa, Ontario, Canada, K1H 7W9
        • The Ottawa Hospital - Riverside Campus; the Arthritis Centre
      • Toronto, Ontario, Canada, M5T 2S8
        • University Health Network; Toronto Western Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2L 1S6
        • Institut de Rhumatologie de Montreal
      • Montreal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneuve- Rosemont; Rheumatology
      • Montreal, Quebec, Canada, H3Z 2Z3
        • Montreal Rheumatic Disease Centre
      • Quebec City, Quebec, Canada, G1V 3M7
        • Groupe de Recherche en Rhumatologie et Maladies Osseuses
      • Trois-rivieres, Quebec, Canada, G8Z 1Y2
        • Clin. de Rhumatologie
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal Uni Hospital; Medicine Dept
      • Prague, Czechia, 128500
        • Revmatologicky ustav
      • Bois Guillaume, France, 76233
        • Hopital De Bois Guillaume; Rhumatologie
      • Cahors, France, 46005
        • CH Jean Rougier; Rhumato Reed Fonctionnelle
      • Colmar, France, 68024
        • Hopital Louis Pasteur; Service De Medecine Interne et de Rhumatologie
      • Le Mans, France, 72037
        • CH Du Mans; Rhumatologie
      • Lille, France, 59037
        • Hopital B Roger Salengro; Rhumatologie
      • Marseille, France, 13285
        • Fondation Hopital Saint Joseph; Rhumatologie
      • Montpellier, France, 34295
        • Hopital Lapeyronie; Immunologie Rhumatologie
      • Nice, France, 06202
        • Hopital de L'Archet; Rhumatologie
      • Paris, France, 75679
        • Hopital Cochin; Rhumatologie A
      • Paris, France, 75679
        • Hopital Cochin; Rhumatologie B
      • Aachen, Germany, 52064
        • Praxis Dr. med. Reiner Kurthen
      • Berlin, Germany, 14059
        • Schlosspark Klinik; Abt. Rheumatologie
      • Duisburg, Germany, 47055
        • Klinik Duisburg; Klinik Für Rheumatologie
      • Frankfurt, Germany, 60596
        • Endokrinologikum Frankfurt; Rheumatologie & Gynäkologie
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie
      • Giessen, Germany, 35392
        • Internistisches Praxiszentrum Am Krankenhaus Balserische Stiftung; Innere Medizin / Rheumatologie
      • Hagen, Germany, 58135
        • Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik
      • Hannover, Germany, 30625
        • Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie
      • Heidelberg, Germany, 69120
        • Rheumapraxis PD Dr.med. Bernhard Heilig
      • Heidelberg, Germany, 69120
        • UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V
      • Heidelberg, Germany, 69121
        • Fachärzte für Innere Medizin - Rheumatologie - Dr. med. Ino Gao und Dr. med. Maria Anna Meier
      • Köln, Germany, 50924
        • Klinik der Uni zu Köln; Klinik für Innere Medizin
      • Mainz, Germany, 55131
        • Uniklinik Mainz; I. Medizinische Klinik
      • München, Germany, 80336
        • Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV
      • Osnabrück, Germany, 49074
        • Rheumapraxis an der Hase
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
      • Budapest, Hungary, 1023
        • Orszagos Reumatologiai es Fizioterapias Intezet
      • Budapest, Hungary, 1027
        • Budai Irgalmasrendi Kórház KHT. II. Reumatológia
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
      • Szombathely, Hungary, 9700
        • Vas Megye Es Szombathely M.J.V. Markusovszky Korhaza
      • Beer Sheva, Israel, 8410101
        • Soroka Medical Center; Reumatology
      • Beer Yaakov, Israel, 6093000
        • Assaf Harofe; Dept of Medicine B
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center; Heamatology Dept
      • Petach Tikva, Israel, 4941492
        • Beilinson Medical Center; Rheumatology
      • Tel Aviv, Israel, 6423906
        • Sourasky / Ichilov Hospital; Rheumatology
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italy, 42100
        • Arcispedale Santa Maria Nuova; Reumatologia
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Università Degli Studi Di Genova - Dimi; Reumatologia
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
        • Irccs Policlinico San Matteo; Reumatologia Adulti
    • Toscana
      • Pisa, Toscana, Italy, 56100
        • Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia
      • Aomori, Japan, 037-0053
        • Seihoku Chuoh Hospital; Department Of Rheumatology
      • Fukuoka, Japan, 807-8555
        • Univ. of Occupational and Environmental Health; Rheumatology, Clinical Immunology and Medicine
      • Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center; Rheumatology and Internal Medicine
      • Hiroshima, Japan, 739-0002
        • Higashihiroshima Memorial Hospital; Rheumatology, Internal Medicine
      • Hokkaido, Japan, 060-8648
        • Hokkaido Uni Hospital; Second Department of Internal Medicine
      • Hyogo, Japan, 673-1462
        • Matsubara Mayflower Hospital; Rheumatology
      • Nagasaki, Japan, 857-1195
        • Sasebo Chuo Hospital ; Internal Medicine
      • Osaka, Japan, 586-8521
        • Osaka Minami Medical Center; Rheumatoid Arthritis
      • Saitama, Japan, 350-0495
        • Saitama Medical University Hospital ; Rheumatology and Applied Immunology
      • Saitama, Japan, 350-0844
        • Saitama Medical Center/School; Rheumatology, Clinical immunology
      • Shizuoka, Japan, 430-8558
        • Seirei Hamamatsu General Hospital; Rheumatology
      • Tochigi, Japan, 329-0498
        • Jichi Medical School Hospital; Rheumatology and Clinical Immunology
      • Tokyo, Japan, 162-0054
        • Tokyo Women's Medical University
      • Tokyo, Japan, 113-8519
        • Tokyo Medical & Dental University; Medicine & Rheumatology
      • Guadalajara, Mexico, 44650
        • Consultorio Privado Dr. Javier Orozco
      • Mexicali, Mexico, 21100
        • Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
      • Mexico, Mexico, 44620
        • Unidad De Enfermedades; Cronico Degenerativas, SC.
      • Obregon, Mexico, 85000
        • Clinica San Jose Obregon; Rheumatology
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum; Division of Clinical Immunology & Rheumatology
      • Eindhoven, Netherlands, 5631 BM
        • Maxima Medisch Centrum; Rheumatology
      • Timaru, New Zealand, 7910
        • Timaru Hospital
      • Panama City, Panama, 32400
        • Centro de Infusion Marbella; Consultorios Royal Center Num 214
      • Callao, Peru
        • Hospital Alberto Sabogal Sologuren; Remautology
      • Lima, Peru, 11
        • Clinica San Felipe; Consultorio de Reumatología
      • Lima, Peru, 11
        • Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
      • Elblag, Poland, 82-300
        • Wojewodzki Szpital Zespolony; Oddzial Reumatologii
      • Szczecin, Poland, 71-252
        • Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1
      • Piestany, Slovakia, 921 01
        • Narodny Ustav Reumatickych Chorob - 34479; Rheumatology
      • Ljubljana, Slovenia, 1000
        • Bolnica dr. Petra Drzaja, Klinicni center Ljubljana; Klinicni oddelek za revmatologijo
      • Badajoz, Spain, 06080
        • Hospital Universitario Infanta Cristina; Servicio de Reumatologia
      • Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge; Servicio de Reumatologia
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial; Servicio de Reumatologia
      • Burgos, Spain, 06006
        • Complejo Asistencial Universitario de Burgos; Servicio de Reumatología
      • Guadalajara, Spain, 19002
        • Hospital General Universitario de Guadalajara; Servicio de Reumatologia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Reumatologia
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca; Servicio de Reumatologia
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Hospital Univ. Central de Asturias; Servicio de Reumatologia
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli; Servicio de Reumatologia
    • Cadiz
      • Jerez de La Frontera, Cadiz, Spain, 11407
        • Hospital de Jerez de la Frontera; Servicio de Reumatologia
    • Cantabria
      • Torrelavega, Cantabria, Spain, 39300
        • Hospital Sierrallana; Servicio de Reumatologia
    • LA Coruña
      • La Coruna, LA Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Reumatologia
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto; Servicio de Reumatologia
      • Linkoeping, Sweden, 58185
        • Uni Hospital Linkoeping; Dept. of Rheumatology
      • Uppsala, Sweden, 75185
        • Akademiska sjukhuset, Reumatologkliniken
      • Lausanne, Switzerland, 1011
        • CHUV; Hôpital orthopédique, Rhumatologie
      • Zürich, Switzerland, 8091
        • Universitätsspital Zürich; Klinik für Rheumatologie
      • Kaohsiung, Taiwan, 00833
        • Chang Gung Medical Foundation - Kaohsiung; Rheumatology
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group; Llc, Central
      • Birmingham, Alabama, United States, 35205
        • Rheumatology Associates
      • Huntsville, Alabama, United States, 35801
        • Rheumatology Associates of North Alabama
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Mesa, Arizona, United States, 85208
        • Arthrocare, Arthritis Care and Research, P.C.
      • Tucson, Arizona, United States, 85704
        • Catalina Pointe Clinical Research, Inc.
      • Tucson, Arizona, United States, 85724
        • Uni of Arizona Health Science Center; Dept of Rheumatology/Immunology
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • CHI St. Vincent Medical Group Hot Springs
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Diagnostic Clinic
    • California
      • La Jolla, California, United States, 92037
        • Allergy & Rheumatology Centre
      • Long Beach, California, United States, 90808
        • Private practice
      • Los Alamitos, California, United States, 90720
        • Valerius Medical Group & Research Ctr of Greater Long Beach
      • Los Angeles, California, United States, 90045
        • Pacific Arthritis Care Center
      • Los Angeles, California, United States, 90033
        • Uni of Southern California School of Medicine
      • Palo Alto, California, United States, 94304
        • Stanford Uni Medical Center; Divison of Rheumatology
      • San Diego, California, United States, 92108
        • San Diego Arthritis Med Clnc
      • San Diego, California, United States, 92093
        • Ucsd, Dept of Medicine; Rheumatology
      • San Leandro, California, United States, 94578
        • East Bay Rheumatology
      • Torrance, California, United States, 90505
        • Arthritis Treatment Center of South Bay
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
      • Colorado Springs, Colorado, United States, 80920
        • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
    • Connecticut
      • Camden, Connecticut, United States, 06510
        • Arthritis & Osteoporosis Center P.C.
      • Trumbull, Connecticut, United States, 06611
        • New England Research Associates
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Rheumatolgy Consultants of Deleware
      • Newark, Delaware, United States, 19713
        • Javed Rheumatology Associates, Inc.
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis & Rheumatism; Disease Specialities
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Center Palm Harbor
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Rsrch of Florida, Inc.
      • Sarasota, Florida, United States, 34239
        • Sarasota Arthritis Center; Research Dept
      • South Miami, Florida, United States, 33143
        • Center For Arthritis; Research Dept
      • Tampa, Florida, United States, 33614
        • Burnette & Silverfield, MDS
      • Tampa, Florida, United States, 33609
        • SW Florida Clinical Research
      • Tampa, Florida, United States, 33612
        • Tampa General Hospital; Rheumatology Research Dept
      • Zephyrhills, Florida, United States, 33540
        • Florida Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Center For Clinical Research.
      • Cumming, Georgia, United States, 30041
        • Csi Research, Inc.
      • Marietta, Georgia, United States, 30060
        • Marietta Rheumatology Associates, PC
    • Idaho
      • Boise, Idaho, United States, 83702
        • Intermountain Orthopaedics
      • Coeur d'Alene, Idaho, United States, 83814
        • Coeur D'Alene Arthritis Clinic
      • Meridian, Idaho, United States, 83642
        • Idaho Arthritis Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Uni of Chicago
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare; Rheumatology
      • Moline, Illinois, United States, 61265
        • Quad City Rheumatology, Sc
      • Morton Grove, Illinois, United States, 60053
        • Illinois Bone & Joint Inst.
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Diagnostic Rheumatology & Research
      • Indianapolis, Indiana, United States, 46202-5149
        • Iu Outpatient Clinical Research Facility
      • Munster, Indiana, United States, 46321
        • Medical Specialists Clinical Research Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401
        • Physician'S Clinic of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Uni of Kansas Medical Center
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Center for Arthritis & Osteoporosis
      • Lexington, Kentucky, United States, 40515
        • Bluegrass Comm Research, Inc.
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Center For Better Bone & Joint Healthx
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Baton Rouge Clinic, Amc
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University; Department of Rheumatology
      • Wheaton, Maryland, United States, 20902
        • Center For Rheumatology & Bone Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610
        • Clinical Pharmacology Study Group
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Clinsite;Research Division of Integrated Health Associates
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Research Institute
      • Kalamazoo, Michigan, United States, 49009
        • Rheumatology, P.C.; Medical Arts Building
      • Lansing, Michigan, United States, 48910
        • Fiechtner Research Inc
      • Saint Clair Shores, Michigan, United States, 48080
        • Office of Andrew Sulich, Md
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St Luke's Whiteside Research
      • Duluth, Minnesota, United States, 55805
        • St. Mary'S Duluth Clinic Health System; Rheumatology Dept
      • Eagan, Minnesota, United States, 55121
        • St. Paul Rheumatology
      • Minneapolis, Minnesota, United States, 55416
        • Park Nicollet Inst. ; Rtrc
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Jackson Arthritis Clinic
      • Tupelo, Mississippi, United States, 38802
        • North Mississippi Medical Ctr; Internal Medicine Associates
    • Missouri
      • Florissant, Missouri, United States, 63031
        • David S Rosenberg
      • Saint Louis, Missouri, United States, 63117
        • Clayton Medical Research
      • Saint Louis, Missouri, United States, 63131
        • Physicians Group, LC DBA Rheumatology & Internal Medicine Associates
      • Saint Louis, Missouri, United States, 63141
        • Arthritis Consultants
      • Springfield, Missouri, United States, 65807
        • St. John'S Health System Inc.; St. John'S Medical Research
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Westroads Medical Group
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • Seacoast Arthritis And Osteoporosis Center
      • Nashua, New Hampshire, United States, 03060
        • Nashua Rheumatology - Foundation Medical Partners
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Mark Fisher Md, Facr, Llc
      • Voorhees, New Jersey, United States, 08043
        • Arthritis Rheumatic & Back Disease Associates
    • New York
      • Albany, New York, United States, 12206
        • The Center of Rheumatology
      • Brooklyn, New York, United States, 11201
        • Arthritis & Osteoporosis Center
      • Olean, New York, United States, 14760
        • Southern Tier Arthritis & Rheumatism
      • Rochester, New York, United States, 14618
        • AAIR Research Center
      • Roslyn, New York, United States, 11576
        • Andrew Porges Pc
      • Smithtown, New York, United States, 11787
        • Rheumatology Associates of Long Island
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Arthritis & Osteoporosis Center, PA
      • Belmont, North Carolina, United States, 28012
        • Arthritis Associates
      • Charlotte, North Carolina, United States, 28209
        • Metrolina Medical Research
      • Charlotte, North Carolina, United States, 28210
        • Carolina Bone & Joint P.A.
      • Greenville, North Carolina, United States, 27834
        • Physicians East PA
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • St. Alexius Medical Center; Arthritis Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Deaconess Arthritis Center; Rheumatic Disease Study Group
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Dayton, Ohio, United States, 45402
        • Stat Research, Inc
      • Mayfield, Ohio, United States, 44143
        • David Mandel Inc
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma, Llc
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultants
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Center For Arthritis Therapy & Research
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Eugene, Oregon, United States, 97401
        • PRO Research
      • Lake Oswego, Oregon, United States, 97035
        • Portland Rheumatology Clinic Llc
      • Portland, Oregon, United States, 97213
        • Providence Arthritis Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • East Penn Rheumatology Associates, Pc
      • Erie, Pennsylvania, United States, 16508
        • Arthritis Associates
      • Erie, Pennsylvania, United States, 16508
        • Rheumatology Associates of NW Pa
      • Philadelphia, Pennsylvania, United States, 19152
        • Arthritis Group
      • Wexford, Pennsylvania, United States, 15090
        • Advanced Rheumatology & Arthritis Research Center
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Center of Reading
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Research Center
      • Fountain Inn, South Carolina, United States, 29644
        • Palmetto Clinical Trial Services, LLC
      • Hickory Grove, South Carolina, United States, 28602
        • Unifour Medical Research Associates
      • North Charleston, South Carolina, United States, 29425
        • Medical Uni of South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute
      • Knoxville, Tennessee, United States, 37909
        • Rheumatology Consultants
      • Memphis, Tennessee, United States, 38119
        • Ramesh Gupta - PP
      • Memphis, Tennessee, United States, 38104
        • Arthritis Group
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Center for Clinical Research
      • Amarillo, Texas, United States, 79106
        • Aamr Research Clinic
      • Austin, Texas, United States, 78705
        • Austin Rheumatology Research
      • Austin, Texas, United States, 78705
        • Walter F. Chase, MD, PA
      • Dallas, Texas, United States, 75246
        • Arthritis Centers of Texas
      • Dallas, Texas, United States, 75231-4406
        • Arthritis Care & Diagnostic Center
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research
      • Dallas, Texas, United States, 75231
        • Arthritis Care and Research Centre
      • Dallas, Texas, United States, 75390
        • Uni of Texas Southwestern Medical Center; Internal Medicine
      • Lubbock, Texas, United States, 79424
        • Arthritis & Osteoporosis Associates, LLP
      • Mesquite, Texas, United States, 75150
        • Southwest Rheumatology
      • San Antonio, Texas, United States, 78217
        • Radiant Research
      • San Antonio, Texas, United States, 78217
        • Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases
      • Sugar Land, Texas, United States, 77479
        • Texas Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Uni of Utah Medical Center
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arthritis Clinic of Northern Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Medical Group
    • Washington
      • Seattle, Washington, United States, 98104
        • Seattle Rheumatology Associates
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, Spokane
      • Tacoma, Washington, United States, 98405
        • Office of George Krick, Md
      • Tacoma, Washington, United States, 98405
        • Tacoma Center for Arthritis Research
      • Vancouver, Washington, United States, 98664
        • Vancouver Clinic; Research Dept
      • Yakima, Washington, United States, 98902
        • Clinical Trials Northwest
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Rheumatic Disease Center
      • Onalaska, Wisconsin, United States, 54605
        • Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Oral or parenteral repeating dose
Oral repeating dose
Intravenous repeating dose (200mg)
Intravenous repeating dose (500mg)
EXPERIMENTAL: 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
Oral or parenteral repeating dose
Oral repeating dose
Intravenous repeating dose (200mg)
Intravenous repeating dose (500mg)
PLACEBO_COMPARATOR: 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
Intravenous repeating dose
Oral or parenteral repeating dose
Oral repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses
Time Frame: Weeks 24 and 48
ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.
Weeks 24 and 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Major Clinical Response
Time Frame: Week 48
Major clinical response was defined as achieving an ACR70 response and maintaining this response for a consecutive period of at least 6 months.
Week 48
Percentage of Participants Achieving Disease Activity Score (DAS28) Remission
Time Frame: Weeks 24 and 48
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.
Weeks 24 and 48
Change in DAS28 From Baseline
Time Frame: Weeks 24 and 48
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
Weeks 24 and 48
Percentage of Participants With EULAR Response Rates of Good/ Moderate
Time Frame: Weeks 24 and 48
The EULAR response rate was based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none.
Weeks 24 and 48
Percentage of Participants Achieving an ACR50 Response
Time Frame: Weeks 24 and 48
ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: physician's global assessment of disease activity (MDG), patient's global assessment of disease activity (PGA), patient's assessment of pain, Health Assessment Questionnaire with Disability Index (HAQ-DI), and C-Reactive Protein (CRP).
Weeks 24 and 48
Percentage of Participants Achieving an ACR70 Response
Time Frame: Weeks 24 and 48
ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: physician's global assessment of disease activity (MDG), patient's global assessment of disease activity (PGA), patient's assessment of pain, HAQ-DI and CRP.
Weeks 24 and 48
Percentage of Participants With a Reduction in the HAQ-DI Score
Time Frame: Weeks 24 and 48
Health Assessment Questionnaire - Disability Index (HAQ-DI): The Stanford Health Assessment Questionnaire disability index is a patient reported questionnaire specific for RA. It consists of 20 questions referring to eight component. Reduction in the HAQ-DI score of 0.25 units from baseline to weeks 24 and 48 represented a minimal clinically relevant improvement.
Weeks 24 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2007

Primary Completion (ACTUAL)

January 21, 2010

Study Completion (ACTUAL)

May 14, 2018

Study Registration Dates

First Submitted

May 18, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (ESTIMATE)

May 22, 2007

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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