Study Stopped
Recruitment was fully completed for this study; however, the study was terminated during conduct after the primary endpoint analysis was completed.
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
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
3 other identifiers
interventional
836
24 countries
265
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started May 2007
Longer than P75 for phase_3 rheumatoid-arthritis
265 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2007
CompletedFirst Submitted
Initial submission to the registry
May 18, 2007
CompletedFirst Posted
Study publicly available on registry
May 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2018
CompletedResults Posted
Study results publicly available
August 12, 2019
CompletedAugust 12, 2019
August 1, 2019
2.7 years
May 18, 2007
May 9, 2019
August 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses
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 Outcomes (7)
Percentage of Participants With a Major Clinical Response
Week 48
Percentage of Participants Achieving Disease Activity Score (DAS28) Remission
Weeks 24 and 48
Change in DAS28 From Baseline
Weeks 24 and 48
Percentage of Participants With EULAR Response Rates of Good/ Moderate
Weeks 24 and 48
Percentage of Participants Achieving an ACR50 Response
Weeks 24 and 48
- +2 more secondary outcomes
Study Arms (3)
Ocrelizumab 200 mg x 2 IV + Non-Biologic DMARD Therapy
EXPERIMENTALParticipants 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
Ocrelizumab 500 mg x 2 IV + Non-Biologic DMARD Therapy
EXPERIMENTALParticipants 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
Placebo x 2 IV + Non-Biologic DMARD Therapy
PLACEBO COMPARATORParticipants 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
Interventions
Oral repeating dose
Oral or parenteral repeating dose
Intravenous repeating dose (200mg)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Rheumatic autoimmune disease or inflammatory joint disease, other than RA
- Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
- Roche Pharma AGcollaborator
Study Sites (266)
Pinnacle Research Group; Llc, Central
Anniston, Alabama, 36207, United States
Rheumatology Associates
Birmingham, Alabama, 35205, United States
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801, United States
Arizona Arthritis & Rheumatology Research, Pllc
Mesa, Arizona, 85202, United States
Arthrocare, Arthritis Care and Research, P.C.
Mesa, Arizona, 85208, United States
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, 85704, United States
Uni of Arizona Health Science Center; Dept of Rheumatology/Immunology
Tucson, Arizona, 85724, United States
CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas, 71913, United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas, 72205, United States
Allergy & Rheumatology Centre
La Jolla, California, 92037, United States
Private Practice
Long Beach, California, 90808, United States
Valerius Medical Group & Research Ctr of Greater Long Beach
Los Alamitos, California, 90720, United States
Uni of Southern California School of Medicine
Los Angeles, California, 90033, United States
Pacific Arthritis Care Center
Los Angeles, California, 90045, United States
Stanford Uni Medical Center; Divison of Rheumatology
Palo Alto, California, 94304, United States
Ucsd, Dept of Medicine; Rheumatology
San Diego, California, 92093, United States
San Diego Arthritis Med Clnc
San Diego, California, 92108, United States
East Bay Rheumatology
San Leandro, California, 94578, United States
Arthritis Treatment Center of South Bay
Torrance, California, 90505, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
Colorado Springs, Colorado, 80920, United States
Arthritis & Osteoporosis Center P.C.
Camden, Connecticut, 06510, United States
New England Research Associates
Trumbull, Connecticut, 06611, United States
Rheumatolgy Consultants of Deleware
Lewes, Delaware, 19958, United States
Javed Rheumatology Associates, Inc.
Newark, Delaware, 19713, United States
Arthritis & Rheumatism; Disease Specialities
Aventura, Florida, 33180, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, 32216, United States
Arthritis Center Palm Harbor
Palm Harbor, Florida, 34684, United States
Arthritis Rsrch of Florida, Inc.
Palm Harbor, Florida, 34684, United States
Sarasota Arthritis Center; Research Dept
Sarasota, Florida, 34239, United States
Center For Arthritis; Research Dept
South Miami, Florida, 33143, United States
SW Florida Clinical Research
Tampa, Florida, 33609, United States
Tampa General Hospital; Rheumatology Research Dept
Tampa, Florida, 33612, United States
Burnette & Silverfield, MDS
Tampa, Florida, 33614, United States
Florida Medical Center
Zephyrhills, Florida, 33540, United States
Atlanta Center For Clinical Research.
Atlanta, Georgia, 30342, United States
Csi Research, Inc.
Cumming, Georgia, 30041, United States
Marietta Rheumatology Associates, Pc
Marietta, Georgia, 30060, United States
Intermountain Orthopaedics
Boise, Idaho, 83702, United States
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, 83814, United States
Idaho Arthritis Center
Meridian, Idaho, 83642, United States
Uni of Chicago
Chicago, Illinois, 60637, United States
Evanston Northwestern Healthcare; Rheumatology
Evanston, Illinois, 60201, United States
Quad City Rheumatology, Sc
Moline, Illinois, 61265, United States
Illinois Bone & Joint Inst.
Morton Grove, Illinois, 60053, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Iu Outpatient Clinical Research Facility
Indianapolis, Indiana, 46202-5149, United States
Diagnostic Rheumatology & Research
Indianapolis, Indiana, 46227, United States
Medical Specialists Clinical Research Center
Munster, Indiana, 46321, United States
Physician'S Clinic of Iowa
Cedar Rapids, Iowa, 52401, United States
Uni of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Center For Arthritis & Osteoporosis
Elizabethtown, Kentucky, 42701, United States
Bluegrass Comm Research, Inc.
Lexington, Kentucky, 40515, United States
Kentuckiana Center For Better Bone & Joint Healthx
Louisville, Kentucky, 40202, United States
Baton Rouge Clinic, Amc
Baton Rouge, Louisiana, 70808, United States
Johns Hopkins University; Department of Rheumatology
Baltimore, Maryland, 21224, United States
Center For Rheumatology & Bone Research
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Clinsite;Research Division of Integrated Health Associates
Ann Arbor, Michigan, 48106, United States
Rheumatology, P.C.; Medical Arts Building
Kalamazoo, Michigan, 49009, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Fiechtner Research Inc
Lansing, Michigan, 48910, United States
Office of Andrew Sulich, Md
Saint Clair Shores, Michigan, 48080, United States
St Luke's Whiteside Research
Duluth, Minnesota, 55805, United States
St. Mary'S Duluth Clinic Health System; Rheumatology Dept
Duluth, Minnesota, 55805, United States
St. Paul Rheumatology
Eagan, Minnesota, 55121, United States
Park Nicollet Inst. ; Rtrc
Minneapolis, Minnesota, 55416, United States
Jackson Arthritis Clinic
Flowood, Mississippi, 39232, United States
North Mississippi Medical Ctr; Internal Medicine Associates
Tupelo, Mississippi, 38802, United States
David S Rosenberg
Florissant, Missouri, 63031, United States
St. John'S Health System Inc.; St. John'S Medical Research
Springfield, Missouri, 65807, United States
Clayton Medical Research
St Louis, Missouri, 63117, United States
Physicians Group, LC DBA Rheumatology & Internal Medicine Associates
St Louis, Missouri, 63131, United States
Arthritis Consultants
St Louis, Missouri, 63141, United States
Westroads Medical Group
Omaha, Nebraska, 68114, United States
Seacoast Arthritis and Osteoporosis Center
Dover, New Hampshire, 03820, United States
Nashua Rheumatology - Foundation Medical Partners
Nashua, New Hampshire, 03060, United States
Mark Fisher Md, Facr, Llc
Haddon Heights, New Jersey, 08035, United States
Arthritis Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, 08043, United States
The Center of Rheumatology
Albany, New York, 12206, United States
Arthritis & Osteoporosis Center
Brooklyn, New York, 11201, United States
Southern Tier Arthritis & Rheumatism
Olean, New York, 14760, United States
Aair Research Center
Rochester, New York, 14618, United States
Andrew Porges Pc
Roslyn, New York, 11576, United States
Rheumatology Associates of Long Island
Smithtown, New York, 11787, United States
Asheville Arthritis & Osteoporosis Center, PA
Asheville, North Carolina, 28803, United States
Arthritis Associates
Belmont, North Carolina, 28012, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Carolina Bone & Joint P.A.
Charlotte, North Carolina, 28210, United States
Physicians East Pa
Greenville, North Carolina, 27834, United States
St. Alexius Medical Center; Arthritis Clinic
Bismarck, North Dakota, 58501, United States
Deaconess Arthritis Center; Rheumatic Disease Study Group
Cincinnati, Ohio, 45219, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Stat Research, Inc
Dayton, Ohio, 45402, United States
David Mandel Inc
Mayfield, Ohio, 44143, United States
Paramount Medical Research
Middleburg Heights, Ohio, 44130, United States
Health Research of Oklahoma, Llc
Oklahoma City, Oklahoma, 73103, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, 74104, United States
Healthcare Research Consultants
Tulsa, Oklahoma, 74135, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Pro Research
Eugene, Oregon, 97401, United States
Portland Rheumatology Clinic Llc
Lake Oswego, Oregon, 97035, United States
Providence Arthritis Center
Portland, Oregon, 97213, United States
East Penn Rheumatology Associates, Pc
Bethlehem, Pennsylvania, 18015, United States
Arthritis Associates
Erie, Pennsylvania, 16508, United States
Rheumatology Associates of NW Pa
Erie, Pennsylvania, 16508, United States
Arthritis Group
Philadelphia, Pennsylvania, 19152, United States
Advanced Rheumatology & Arthritis Research Center
Wexford, Pennsylvania, 15090, United States
Clinical Research Center of Reading
Wyomissing, Pennsylvania, 19610, United States
Low Country Research Center
Charleston, South Carolina, 29406, United States
Palmetto Clinical Trial Services, LLC
Fountain Inn, South Carolina, 29644, United States
Unifour Medical Research Associates
Hickory Grove, South Carolina, 28602, United States
Medical Uni of South Carolina
North Charleston, South Carolina, 29425, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Rheumatology Consultants
Knoxville, Tennessee, 37909, United States
Arthritis Group
Memphis, Tennessee, 38104, United States
Ramesh Gupta - PP
Memphis, Tennessee, 38119, United States
Aamr Research Clinic
Amarillo, Texas, 79106, United States
Amarillo Center For Clinical Research
Amarillo, Texas, 79124, United States
Austin Rheumatology Research
Austin, Texas, 78705, United States
Walter F. Chase, Md, Pa
Austin, Texas, 78705, United States
Arthritis Care & Diagnostic Center
Dallas, Texas, 75231-4406, United States
Arthritis Care and Research Centre
Dallas, Texas, 75231, United States
Metroplex Clinical Research
Dallas, Texas, 75231, United States
Arthritis Centers of Texas
Dallas, Texas, 75246, United States
Uni of Texas Southwestern Medical Center; Internal Medicine
Dallas, Texas, 75390, United States
Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas, 79424, United States
Southwest Rheumatology
Mesquite, Texas, 75150, United States
Radiant Research
San Antonio, Texas, 78217, United States
Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases
San Antonio, Texas, 78217, United States
Texas Research Center
Sugar Land, Texas, 77479, United States
Uni of Utah Medical Center
Salt Lake City, Utah, 84132, United States
Arthritis Clinic of Northern Virginia
Arlington, Virginia, 22205, United States
Sentara Medical Group
Norfolk, Virginia, 23507, United States
Seattle Rheumatology Associates
Seattle, Washington, 98104, United States
Arthritis Northwest, Spokane
Spokane, Washington, 99204, United States
Office of George Krick, Md
Tacoma, Washington, 98405, United States
Tacoma Center For Arthritis Research
Tacoma, Washington, 98405, United States
Vancouver Clinic; Research Dept
Vancouver, Washington, 98664, United States
Clinical Trials Northwest
Yakima, Washington, 98902, United States
Rheumatic Disease Center
Glendale, Wisconsin, 53217, United States
Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med
Onalaska, Wisconsin, 54605, United States
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO, Argentina
Inst. de Rehabilitacion Psicofisica; Reumathology
Buenos Aires, C1428DQG, Argentina
CER Instituto Médico; REUMATOLOGÍA
San Juan Bautista, B1878DVB, Argentina
Sunshine Coast Rheumatology Research Unit
Maroochydore, Queensland, 4558, Australia
Princess Alexandra Hospital; Rheumatology
Woolloongabba, Queensland, 4102, Australia
Royal Perth Hospital; Rheumatology
Shenton Park, Western Australia, 6008, Australia
AZ Sint Jan
Bruges, 8000, Belgium
CHU Brugmann (Victor Horta)
Brussels, 1020, Belgium
CHU de Charleroi
Charleroi, 6000, Belgium
UZ Gent
Ghent, 9000, Belgium
GHdC Site Saint-Joseph
Gilly (Charleroi), 6000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
Centro Internacional de Pesquisa; Reumatologia
Goiânia, Goiás, 74110010, Brazil
Centro de Estudos em Terapias Inovadoras - CETI
Curtiba, Paraná, 80030-110, Brazil
Hospital Universitario Clementino Fraga Filho - UFRJ; Reumatologia
Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, 13083-888, Brazil
Hospital Abreu Sodre - AACD;Pesquisa Clinica
São Paulo, São Paulo, 04027-000, Brazil
The Governors of the Uni of Alberta; Heritage Medical Research Centre
Edmonton, Alberta, T6G 2S2, Canada
Arthritis Research Centre
Vancouver, British Columbia, V5Z 1L7, Canada
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M3, Canada
Wharton Medical Clinic; Burlington
Burlington, Ontario, L7R 1E2, Canada
Mac Research Inc.
Hamilton, Ontario, L8N 2B6, Canada
K-W Musculoskeletal Research
Kitchener, Ontario, N2M 5N6, Canada
St. Joseph'S Health Care Centre; Rheumatology
London, Ontario, N6A 4V2, Canada
Credit Valley, Rheumatology
Mississauga, Ontario, L5M 2V8, Canada
The Ottawa Hospital - Riverside Campus; the Arthritis Centre
Ottawa, Ontario, K1H 7W9, Canada
University Health Network; Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Hopital Maisonneuve- Rosemont; Rheumatology
Montreal, Quebec, H1T 2M4, Canada
Institut de Rhumatologie de Montreal
Montreal, Quebec, H2L 1S6, Canada
Montreal Rheumatic Disease Centre
Montreal, Quebec, H3Z 2Z3, Canada
Groupe de Recherche En Rhumatologie Et Maladies Osseuses
Québec, Quebec, G1V 3M7, Canada
Clin. de Rhumatologie
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Royal Uni Hospital; Medicine Dept
Saskatoon, Saskatchewan, S7N 0W8, Canada
Revmatologicky Ustav
Prague, 128500, Czechia
Hopital De Bois Guillaume; Rhumatologie
Bois-Guillaume, 76233, France
CH Jean Rougier; Rhumato Reed Fonctionnelle
Cahors, 46005, France
Hopital Louis Pasteur; Service De Medecine Interne et de Rhumatologie
Colmar, 68024, France
CH Du Mans; Rhumatologie
Le Mans, 72037, France
Hopital B Roger Salengro; Rhumatologie
Lille, 59037, France
Fondation Hopital Saint Joseph; Rhumatologie
Marseille, 13285, France
Hopital Lapeyronie; Immunologie Rhumatologie
Montpellier, 34295, France
Hopital de L'Archet; Rhumatologie
Nice, 06202, France
Hopital Cochin; Rhumatologie A
Paris, 75679, France
Hopital Cochin; Rhumatologie B
Paris, 75679, France
Praxis Dr. med. Reiner Kurthen
Aachen, 52064, Germany
Schlosspark Klinik; Abt. Rheumatologie
Berlin, 14059, Germany
Klinik der Uni zu Köln; Klinik für Innere Medizin
Cologne, 50924, Germany
Klinik Duisburg; Klinik Für Rheumatologie
Duisburg, 47055, Germany
Endokrinologikum Frankfurt; Rheumatologie & Gynäkologie
Frankfurt, 60596, Germany
Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie
Freiburg im Breisgau, 79106, Germany
Internistisches Praxiszentrum Am Krankenhaus Balserische Stiftung; Innere Medizin / Rheumatologie
Giessen, 35392, Germany
Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik
Hagen, 58135, Germany
Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie
Hanover, 30625, Germany
Rheumapraxis PD Dr.med. Bernhard Heilig
Heidelberg, 69120, Germany
UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V
Heidelberg, 69120, Germany
Fachärzte für Innere Medizin - Rheumatologie - Dr. med. Ino Gao und Dr. med. Maria Anna Meier
Heidelberg, 69121, Germany
Uniklinik Mainz; I. Medizinische Klinik
Mainz, 55131, Germany
Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV
München, 80336, Germany
Rheumapraxis an der Hase
Osnabrück, 49074, Germany
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
Würzburg, 97080, Germany
Orszagos Reumatologiai Es Fizioterapias Intezet
Budapest, 1023, Hungary
Budai Irgalmasrendi Kórház KHT. II. Reumatológia
Budapest, 1027, Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
Debrecen, 4032, Hungary
Vas Megye Es Szombathely M.J.V. Markusovszky Korhaza
Szombathely, 9700, Hungary
Assaf Harofe; Dept of Medicine B
Beer Yaakov, 6093000, Israel
Soroka Medical Center; Reumatology
Beersheba, 8410101, Israel
Meir Medical Center; Heamatology Dept
Kfar Saba, 4428164, Israel
Beilinson Medical Center; Rheumatology
Petah Tikva, 4941492, Israel
Sourasky / Ichilov Hospital; Rheumatology
Tel Aviv, 6423906, Israel
Arcispedale Santa Maria Nuova; Reumatologia
Reggio Emilia, Emilia-Romagna, 42100, Italy
Università Degli Studi Di Genova - Dimi; Reumatologia
Genoa, Liguria, 16132, Italy
Irccs Policlinico San Matteo; Reumatologia Adulti
Pavia, Lombardy, 27100, Italy
Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia
Pisa, Tuscany, 56100, Italy
Seihoku Chuoh Hospital; Department Of Rheumatology
Aomori, 037-0053, Japan
Univ. of Occupational and Environmental Health; Rheumatology, Clinical Immunology and Medicine
Fukuoka, 807-8555, Japan
National Hospital Organization Kyushu Medical Center; Rheumatology and Internal Medicine
Fukuoka, 810-8563, Japan
Higashihiroshima Memorial Hospital; Rheumatology, Internal Medicine
Hiroshima, 739-0002, Japan
Hokkaido Uni Hospital; Second Department of Internal Medicine
Hokkaido, 060-8648, Japan
Matsubara Mayflower Hospital; Rheumatology
Hyōgo, 673-1462, Japan
Sasebo Chuo Hospital ; Internal Medicine
Nagasaki, 857-1195, Japan
Osaka Minami Medical Center; Rheumatoid Arthritis
Osaka, 586-8521, Japan
Saitama Medical University Hospital ; Rheumatology and Applied Immunology
Saitama, 350-0495, Japan
Saitama Medical Center/School; Rheumatology, Clinical immunology
Saitama, 350-0844, Japan
Seirei Hamamatsu General Hospital; Rheumatology
Shizuoka, 430-8558, Japan
Jichi Medical School Hospital; Rheumatology and Clinical Immunology
Tochigi, 329-0498, Japan
Tokyo Medical & Dental University; Medicine & Rheumatology
Tokyo, 113-8519, Japan
Tokyo Women's Medical University
Tokyo, 162-0054, Japan
Consultorio Privado Dr. Javier Orozco
Guadalajara, 44650, Mexico
Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
Mexicali, 21100, Mexico
Unidad De Enfermedades; Cronico Degenerativas, SC.
México, 44620, Mexico
Clinica San Jose Obregon; Rheumatology
Obregón, 85000, Mexico
Academisch Medisch Centrum; Division of Clinical Immunology & Rheumatology
Amsterdam, 1105 AZ, Netherlands
Maxima Medisch Centrum; Rheumatology
Eindhoven, 5631 BM, Netherlands
Timaru Hospital
Timaru, 7910, New Zealand
Centro de Infusion Marbella; Consultorios Royal Center Num 214
Panama City, 32400, Panama
Hospital Alberto Sabogal Sologuren; Remautology
Callao, Peru
Clinica San Felipe; Consultorio de Reumatología
Lima, 11, Peru
Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología
Lima, 11, Peru
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
Bydgoszcz, 85-168, Poland
Wojewodzki Szpital Zespolony; Oddzial Reumatologii
Elblag, 82-300, Poland
Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1
Szczecin, 71-252, Poland
Narodny Ustav Reumatickych Chorob - 34479; Rheumatology
Piešťany, 921 01, Slovakia
Bolnica dr. Petra Drzaja, Klinicni center Ljubljana; Klinicni oddelek za revmatologijo
Ljubljana, 1000, Slovenia
Corporacio Sanitaria Parc Tauli; Servicio de Reumatologia
Sabadell, Barcelona, 08208, Spain
Hospital de Jerez de la Frontera; Servicio de Reumatologia
Jerez de la Frontera, Cadiz, 11407, Spain
Hospital Sierrallana; Servicio de Reumatologia
Torrelavega, Cantabria, 39300, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Reumatologia
A Coruña, LA Coruña, 15006, Spain
Hospital Univ. Central de Asturias; Servicio de Reumatologia
Oviedo, Principality of Asturias, 33006, Spain
Hospital de Basurto; Servicio de Reumatologia
Bilbao, Vizcaya, 48013, Spain
Hospital Universitario Infanta Cristina; Servicio de Reumatologia
Badajoz, 06080, Spain
Hospital Clinic i Provincial; Servicio de Reumatologia
Barcelona, 08036, Spain
Hospital Universitari de Bellvitge; Servicio de Reumatologia
Barcelona, 08907, Spain
Complejo Asistencial Universitario de Burgos; Servicio de Reumatología
Burgos, 06006, Spain
Hospital General Universitario de Guadalajara; Servicio de Reumatologia
Guadalajara, 19002, Spain
Hospital Universitario 12 de Octubre; Servicio de Reumatologia
Madrid, 28041, Spain
Hospital Clinico Universitario de Salamanca; Servicio de Reumatologia
Salamanca, 37007, Spain
Uni Hospital Linkoeping; Dept. of Rheumatology
Linköping, 58185, Sweden
Akademiska sjukhuset, Reumatologkliniken
Uppsala, 75185, Sweden
CHUV; Hôpital orthopédique, Rhumatologie
Lausanne, 1011, Switzerland
Universitätsspital Zürich; Klinik für Rheumatologie
Zurich, 8091, Switzerland
Chang Gung Medical Foundation - Kaohsiung; Rheumatology
Kaohsiung City, 00833, Taiwan
Related Publications (2)
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.
PMID: 24498318DERIVEDTak 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.
PMID: 22389919DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2007
First Posted
May 22, 2007
Study Start
May 15, 2007
Primary Completion
January 21, 2010
Study Completion
May 14, 2018
Last Updated
August 12, 2019
Results First Posted
August 12, 2019
Record last verified: 2019-08