AzTrials
AzTrials

Rheumatoid ArthritisPhase 3SCRIPTNCT00476996

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)

A Phase 3 study testing Leflunomide, Methotrexate and Ocrelizumab in people with Rheumatoid Arthritis, run by Genentech, Inc. at 266 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Leflunomide, Methotrexate and Ocrelizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
836 participants
Where
266 sitesin 25 countries
Study dates
15 May 2007to 14 May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

266 sites in 25 countries.

266 sites in 25 countries

United States144 sites

  • The Center of Rheumatology

    Albany, New York, 12206

  • Aamr Research Clinic

    Amarillo, Texas, 79106

  • Amarillo Center For Clinical Research

    Amarillo, Texas, 79124

  • Clinsite;Research Division of Integrated Health Associates

    Ann Arbor, Michigan, 48106

  • Pinnacle Research Group; Llc, Central

    Anniston, Alabama, 36207

  • Arthritis Clinic of Northern Virginia

    Arlington, Virginia, 22205

  • Asheville Arthritis & Osteoporosis Center, PA

    Asheville, North Carolina, 28803

  • Atlanta Center For Clinical Research.

    Atlanta, Georgia, 30342

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Austin Rheumatology Research

    Austin, Texas, 78705

  • Walter F. Chase, Md, Pa

    Austin, Texas, 78705

  • Arthritis & Rheumatism; Disease Specialities

    Aventura, Florida, 33180

  • Johns Hopkins University; Department of Rheumatology

    Baltimore, Maryland, 21224

  • Baton Rouge Clinic, Amc

    Baton Rouge, Louisiana, 70808

  • Arthritis Associates

    Belmont, North Carolina, 28012

  • Bend Memorial Clinic

    Bend, Oregon, 97701

  • East Penn Rheumatology Associates, Pc

    Bethlehem, Pennsylvania, 18015

  • Rheumatology Associates

    Birmingham, Alabama, 35205

  • St. Alexius Medical Center; Arthritis Clinic

    Bismarck, North Dakota, 58501

  • Intermountain Orthopaedics

    Boise, Idaho, 83702

  • Arthritis & Osteoporosis Center

    Brooklyn, New York, 11201

  • Arthritis & Osteoporosis Center P.C.

    Camden, Connecticut, 06510

  • Physician'S Clinic of Iowa

    Cedar Rapids, Iowa, 52401

  • Low Country Research Center

    Charleston, South Carolina, 29406

  • Metrolina Medical Research

    Charlotte, North Carolina, 28209

  • Carolina Bone & Joint P.A.

    Charlotte, North Carolina, 28210

  • Uni of Chicago

    Chicago, Illinois, 60637

  • Deaconess Arthritis Center; Rheumatic Disease Study Group

    Cincinnati, Ohio, 45219

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Coeur D'Alene Arthritis Clinic

    Coeur d'Alene, Idaho, 83814

  • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

    Colorado Springs, Colorado, 80920

  • Csi Research, Inc.

    Cumming, Georgia, 30041

  • Arthritis Care & Diagnostic Center

    Dallas, Texas, 75231-4406

  • Arthritis Care and Research Centre

    Dallas, Texas, 75231

  • Metroplex Clinical Research

    Dallas, Texas, 75231

  • Arthritis Centers of Texas

    Dallas, Texas, 75246

  • Uni of Texas Southwestern Medical Center; Internal Medicine

    Dallas, Texas, 75390

  • Stat Research, Inc

    Dayton, Ohio, 45402

  • Seacoast Arthritis and Osteoporosis Center

    Dover, New Hampshire, 03820

  • St Luke's Whiteside Research

    Duluth, Minnesota, 55805

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

    Duluth, Minnesota, 55805

  • St. Paul Rheumatology

    Eagan, Minnesota, 55121

  • Center For Arthritis & Osteoporosis

    Elizabethtown, Kentucky, 42701

  • Arthritis Associates

    Erie, Pennsylvania, 16508

  • Rheumatology Associates of NW Pa

    Erie, Pennsylvania, 16508

  • Pro Research

    Eugene, Oregon, 97401

  • Evanston Northwestern Healthcare; Rheumatology

    Evanston, Illinois, 60201

  • David S Rosenberg

    Florissant, Missouri, 63031

  • Jackson Arthritis Clinic

    Flowood, Mississippi, 39232

  • Palmetto Clinical Trial Services, LLC

    Fountain Inn, South Carolina, 29644

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Physicians East Pa

    Greenville, North Carolina, 27834

  • Mark Fisher Md, Facr, Llc

    Haddon Heights, New Jersey, 08035

  • Unifour Medical Research Associates

    Hickory Grove, South Carolina, 28602

  • CHI St. Vincent Medical Group Hot Springs

    Hot Springs, Arkansas, 71913

  • Rheumatology Associates of North Alabama

    Huntsville, Alabama, 35801

  • Iu Outpatient Clinical Research Facility

    Indianapolis, Indiana, 46202-5149

  • Diagnostic Rheumatology & Research

    Indianapolis, Indiana, 46227

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida, 32216

  • Rheumatology, P.C.; Medical Arts Building

    Kalamazoo, Michigan, 49009

  • Borgess Research Institute

    Kalamazoo, Michigan, 49048

  • Uni of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Rheumatology Consultants

    Knoxville, Tennessee, 37909

  • Allergy & Rheumatology Centre

    La Jolla, California, 92037

  • Portland Rheumatology Clinic Llc

    Lake Oswego, Oregon, 97035

  • Fiechtner Research Inc

    Lansing, Michigan, 48910

  • Rheumatolgy Consultants of Deleware

    Lewes, Delaware, 19958

  • Bluegrass Comm Research, Inc.

    Lexington, Kentucky, 40515

  • Little Rock Diagnostic Clinic

    Little Rock, Arkansas, 72205

  • Private Practice

    Long Beach, California, 90808

  • Valerius Medical Group & Research Ctr of Greater Long Beach

    Los Alamitos, California, 90720

  • Uni of Southern California School of Medicine

    Los Angeles, California, 90033

  • Pacific Arthritis Care Center

    Los Angeles, California, 90045

  • Kentuckiana Center For Better Bone & Joint Healthx

    Louisville, Kentucky, 40202

  • Arthritis & Osteoporosis Associates, LLP

    Lubbock, Texas, 79424

  • Marietta Rheumatology Associates, Pc

    Marietta, Georgia, 30060

  • David Mandel Inc

    Mayfield, Ohio, 44143

  • Arthritis Group

    Memphis, Tennessee, 38104

  • Ramesh Gupta - PP

    Memphis, Tennessee, 38119

  • Idaho Arthritis Center

    Meridian, Idaho, 83642

  • Arizona Arthritis & Rheumatology Research, Pllc

    Mesa, Arizona, 85202

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

    Mesa, Arizona, 85208

  • Southwest Rheumatology

    Mesquite, Texas, 75150

  • Paramount Medical Research

    Middleburg Heights, Ohio, 44130

  • Park Nicollet Inst. ; Rtrc

    Minneapolis, Minnesota, 55416

  • Quad City Rheumatology, Sc

    Moline, Illinois, 61265

  • Illinois Bone & Joint Inst.

    Morton Grove, Illinois, 60053

  • Medical Specialists Clinical Research Center

    Munster, Indiana, 46321

  • Nashua Rheumatology - Foundation Medical Partners

    Nashua, New Hampshire, 03060

  • Javed Rheumatology Associates, Inc.

    Newark, Delaware, 19713

  • Sentara Medical Group

    Norfolk, Virginia, 23507

  • Medical Uni of South Carolina

    North Charleston, South Carolina, 29425

  • Health Research of Oklahoma, Llc

    Oklahoma City, Oklahoma, 73103

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Southern Tier Arthritis & Rheumatism

    Olean, New York, 14760

  • Westroads Medical Group

    Omaha, Nebraska, 68114

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

    Onalaska, Wisconsin, 54605

  • Arthritis Center Palm Harbor

    Palm Harbor, Florida, 34684

  • Arthritis Rsrch of Florida, Inc.

    Palm Harbor, Florida, 34684

  • Stanford Uni Medical Center; Divison of Rheumatology

    Palo Alto, California, 94304

  • Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Providence Arthritis Center

    Portland, Oregon, 97213

  • Aair Research Center

    Rochester, New York, 14618

  • Andrew Porges Pc

    Roslyn, New York, 11576

  • Office of Andrew Sulich, Md

    Saint Clair Shores, Michigan, 48080

  • Uni of Utah Medical Center

    Salt Lake City, Utah, 84132

  • Radiant Research

    San Antonio, Texas, 78217

  • Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases

    San Antonio, Texas, 78217

  • Ucsd, Dept of Medicine; Rheumatology

    San Diego, California, 92093

  • San Diego Arthritis Med Clnc

    San Diego, California, 92108

  • East Bay Rheumatology

    San Leandro, California, 94578

  • Sarasota Arthritis Center; Research Dept

    Sarasota, Florida, 34239

  • Seattle Rheumatology Associates

    Seattle, Washington, 98104

  • Rheumatology Associates of Long Island

    Smithtown, New York, 11787

  • Center For Arthritis; Research Dept

    South Miami, Florida, 33143

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Arthritis Northwest, Spokane

    Spokane, Washington, 99204

  • Springfield Clinic

    Springfield, Illinois, 62703

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

    Springfield, Missouri, 65807

  • Clayton Medical Research

    St Louis, Missouri, 63117

  • Physicians Group, LC DBA Rheumatology & Internal Medicine Associates

    St Louis, Missouri, 63131

  • Arthritis Consultants

    St Louis, Missouri, 63141

  • Texas Research Center

    Sugar Land, Texas, 77479

  • Office of George Krick, Md

    Tacoma, Washington, 98405

  • Tacoma Center For Arthritis Research

    Tacoma, Washington, 98405

  • SW Florida Clinical Research

    Tampa, Florida, 33609

  • Tampa General Hospital; Rheumatology Research Dept

    Tampa, Florida, 33612

  • Burnette & Silverfield, MDS

    Tampa, Florida, 33614

  • Arthritis Treatment Center of South Bay

    Torrance, California, 90505

  • New England Research Associates

    Trumbull, Connecticut, 06611

  • Catalina Pointe Clinical Research, Inc.

    Tucson, Arizona, 85704

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

    Tucson, Arizona, 85724

  • Oklahoma Center For Arthritis Therapy & Research

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

  • North Mississippi Medical Ctr; Internal Medicine Associates

    Tupelo, Mississippi, 38802

  • Vancouver Clinic; Research Dept

    Vancouver, Washington, 98664

  • Arthritis Rheumatic & Back Disease Associates

    Voorhees Township, New Jersey, 08043

  • Advanced Rheumatology & Arthritis Research Center

    Wexford, Pennsylvania, 15090

  • Center For Rheumatology & Bone Research

    Wheaton, Maryland, 20902

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610

  • Clinical Research Center of Reading

    Wyomissing, Pennsylvania, 19610

  • Clinical Trials Northwest

    Yakima, Washington, 98902

  • Florida Medical Center

    Zephyrhills, Florida, 33540

Other trials in United States

Canada16 sites

  • Wharton Medical Clinic; Burlington

    Burlington, Ontario, L7R 1E2

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

    Edmonton, Alberta, T6G 2S2

  • Mac Research Inc.

    Hamilton, Ontario, L8N 2B6

  • K-W Musculoskeletal Research

    Kitchener, Ontario, N2M 5N6

  • St. Joseph'S Health Care Centre; Rheumatology

    London, Ontario, N6A 4V2

  • Credit Valley, Rheumatology

    Mississauga, Ontario, L5M 2V8

  • Hopital Maisonneuve- Rosemont; Rheumatology

    Montreal, Quebec, H1T 2M4

  • Institut de Rhumatologie de Montreal

    Montreal, Quebec, H2L 1S6

  • Montreal Rheumatic Disease Centre

    Montreal, Quebec, H3Z 2Z3

  • The Ottawa Hospital - Riverside Campus; the Arthritis Centre

    Ottawa, Ontario, K1H 7W9

  • Groupe de Recherche En Rhumatologie Et Maladies Osseuses

    Québec, Quebec, G1V 3M7

  • Royal Uni Hospital; Medicine Dept

    Saskatoon, Saskatchewan, S7N 0W8

  • University Health Network; Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Clin. de Rhumatologie

    Trois-Rivières, Quebec, G8Z 1Y2

  • Arthritis Research Centre

    Vancouver, British Columbia, V5Z 1L7

  • Manitoba Clinic

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Germany16 sites

  • Praxis Dr. med. Reiner Kurthen

    Aachen, 52064

  • Schlosspark Klinik; Abt. Rheumatologie

    Berlin, 14059

  • Klinik der Uni zu Köln; Klinik für Innere Medizin

    Cologne, 50924

  • Klinik Duisburg; Klinik Für Rheumatologie

    Duisburg, 47055

  • Endokrinologikum Frankfurt; Rheumatologie & Gynäkologie

    Frankfurt, 60596

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

    Freiburg im Breisgau, 79106

  • Internistisches Praxiszentrum Am Krankenhaus Balserische Stiftung; Innere Medizin / Rheumatologie

    Giessen, 35392

  • Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik

    Hagen, 58135

  • Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie

    Hanover, 30625

  • Rheumapraxis PD Dr.med. Bernhard Heilig

    Heidelberg, 69120

  • UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V

    Heidelberg, 69120

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

    Heidelberg, 69121

  • Uniklinik Mainz; I. Medizinische Klinik

    Mainz, 55131

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

    München, 80336

  • Rheumapraxis an der Hase

    Osnabrück, 49074

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

    Würzburg, 97080

Other trials in Germany

Japan14 sites

  • Seihoku Chuoh Hospital; Department Of Rheumatology

    Aomori, 037-0053

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

    Fukuoka, 807-8555

  • National Hospital Organization Kyushu Medical Center; Rheumatology and Internal Medicine

    Fukuoka, 810-8563

  • Higashihiroshima Memorial Hospital; Rheumatology, Internal Medicine

    Hiroshima, 739-0002

  • Hokkaido Uni Hospital; Second Department of Internal Medicine

    Hokkaido, 060-8648

  • Matsubara Mayflower Hospital; Rheumatology

    Hyōgo, 673-1462

  • Sasebo Chuo Hospital ; Internal Medicine

    Nagasaki, 857-1195

  • Osaka Minami Medical Center; Rheumatoid Arthritis

    Osaka, 586-8521

  • Saitama Medical University Hospital ; Rheumatology and Applied Immunology

    Saitama, 350-0495

  • Saitama Medical Center/School; Rheumatology, Clinical immunology

    Saitama, 350-0844

  • Seirei Hamamatsu General Hospital; Rheumatology

    Shizuoka, 430-8558

  • Jichi Medical School Hospital; Rheumatology and Clinical Immunology

    Tochigi, 329-0498

  • Tokyo Medical & Dental University; Medicine & Rheumatology

    Tokyo, 113-8519

  • Tokyo Women's Medical University

    Tokyo, 162-0054

Other trials in Japan

Spain13 sites

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

    A Coruña, LA Coruña, 15006

  • Hospital Universitario Infanta Cristina; Servicio de Reumatologia

    Badajoz, 06080

  • Hospital Clinic i Provincial; Servicio de Reumatologia

    Barcelona, 08036

  • Hospital Universitari de Bellvitge; Servicio de Reumatologia

    Barcelona, 08907

  • Hospital de Basurto; Servicio de Reumatologia

    Bilbao, Vizcaya, 48013

  • Complejo Asistencial Universitario de Burgos; Servicio de Reumatología

    Burgos, 06006

  • Hospital General Universitario de Guadalajara; Servicio de Reumatologia

    Guadalajara, 19002

  • Hospital de Jerez de la Frontera; Servicio de Reumatologia

    Jerez de la Frontera, Cadiz, 11407

  • Hospital Universitario 12 de Octubre; Servicio de Reumatologia

    Madrid, 28041

  • Hospital Univ. Central de Asturias; Servicio de Reumatologia

    Oviedo, Principality of Asturias, 33006

  • Corporacio Sanitaria Parc Tauli; Servicio de Reumatologia

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Salamanca; Servicio de Reumatologia

    Salamanca, 37007

  • Hospital Sierrallana; Servicio de Reumatologia

    Torrelavega, Cantabria, 39300

Other trials in Spain

France10 sites

  • Hopital De Bois Guillaume; Rhumatologie

    Bois-Guillaume, 76233

  • CH Jean Rougier; Rhumato Reed Fonctionnelle

    Cahors, 46005

  • Hopital Louis Pasteur; Service De Medecine Interne et de Rhumatologie

    Colmar, 68024

  • CH Du Mans; Rhumatologie

    Le Mans, 72037

  • Hopital B Roger Salengro; Rhumatologie

    Lille, 59037

  • Fondation Hopital Saint Joseph; Rhumatologie

    Marseille, 13285

  • Hopital Lapeyronie; Immunologie Rhumatologie

    Montpellier, 34295

  • Hopital de L'Archet; Rhumatologie

    Nice, 06202

  • Hopital Cochin; Rhumatologie A

    Paris, 75679

  • Hopital Cochin; Rhumatologie B

    Paris, 75679

Other trials in France

Belgium7 sites

  • AZ Sint Jan

    Bruges, 8000

  • CHU Brugmann (Victor Horta)

    Brussels, 1020

  • CHU de Charleroi

    Charleroi, 6000

  • UZ Gent

    Ghent, 9000

  • GHdC Site Saint-Joseph

    Gilly (Charleroi), 6000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • ZNA Jan Palfijn

    Merksem, 2170

Other trials in Belgium

Brazil5 sites

  • Hospital das Clinicas - UNICAMP

    Campinas, São Paulo, 13083-888

  • Centro de Estudos em Terapias Inovadoras - CETI

    Curtiba, Paraná, 80030-110

  • Centro Internacional de Pesquisa; Reumatologia

    Goiânia, Goiás, 74110010

  • Hospital Universitario Clementino Fraga Filho - UFRJ; Reumatologia

    Rio de Janeiro, Rio de Janeiro, 21941-590

  • Hospital Abreu Sodre - AACD;Pesquisa Clinica

    São Paulo, São Paulo, 04027-000

Other trials in Brazil

Israel5 sites

  • Assaf Harofe; Dept of Medicine B

    Beer Yaakov, 6093000

  • Soroka Medical Center; Reumatology

    Beersheba, 8410101

  • Meir Medical Center; Heamatology Dept

    Kfar Saba, 4428164

  • Beilinson Medical Center; Rheumatology

    Petah Tikva, 4941492

  • Sourasky / Ichilov Hospital; Rheumatology

    Tel Aviv, 6423906

Other trials in Israel

Hungary4 sites

  • Orszagos Reumatologiai Es Fizioterapias Intezet

    Budapest, 1023

  • Budai Irgalmasrendi Kórház KHT. II. Reumatológia

    Budapest, 1027

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

    Debrecen, 4032

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

    Szombathely, 9700

Other trials in Hungary

Italy4 sites

  • Università Degli Studi Di Genova - Dimi; Reumatologia

    Genoa, Liguria, 16132

  • Irccs Policlinico San Matteo; Reumatologia Adulti

    Pavia, Lombardy, 27100

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

    Pisa, Tuscany, 56100

  • Arcispedale Santa Maria Nuova; Reumatologia

    Reggio Emilia, Emilia-Romagna, 42100

Other trials in Italy

Mexico4 sites

  • Consultorio Privado Dr. Javier Orozco

    Guadalajara, 44650

  • Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

    Mexicali, 21100

  • Unidad De Enfermedades; Cronico Degenerativas, SC.

    México, 44620

  • Clinica San Jose Obregon; Rheumatology

    Obregón, 85000

Other trials in Mexico

Argentina3 sites

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO

  • Inst. de Rehabilitacion Psicofisica; Reumathology

    Buenos Aires, C1428DQG

  • CER Instituto Médico; REUMATOLOGÍA

    San Juan Bautista, B1878DVB

Other trials in Argentina

Australia3 sites

  • Sunshine Coast Rheumatology Research Unit

    Maroochydore, Queensland, 4558

  • Royal Perth Hospital; Rheumatology

    Shenton Park, Western Australia, 6008

  • Princess Alexandra Hospital; Rheumatology

    Woolloongabba, Queensland, 4102

Other trials in Australia

Peru3 sites

  • Hospital Alberto Sabogal Sologuren; Remautology

    Callao

  • Clinica San Felipe; Consultorio de Reumatología

    Lima, 11

  • Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología

    Lima, 11

Other trials in Peru

Poland3 sites

  • Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

    Bydgoszcz, 85-168

  • Wojewodzki Szpital Zespolony; Oddzial Reumatologii

    Elblag, 82-300

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

    Szczecin, 71-252

Other trials in Poland

Netherlands2 sites

  • Academisch Medisch Centrum; Division of Clinical Immunology & Rheumatology

    Amsterdam, 1105 AZ

  • Maxima Medisch Centrum; Rheumatology

    Eindhoven, 5631 BM

Other trials in Netherlands

Sweden2 sites

  • Uni Hospital Linkoeping; Dept. of Rheumatology

    Linköping, 58185

  • Akademiska sjukhuset, Reumatologkliniken

    Uppsala, 75185

Other trials in Sweden

Switzerland2 sites

  • CHUV; Hôpital orthopédique, Rhumatologie

    Lausanne, 1011

  • Universitätsspital Zürich; Klinik für Rheumatologie

    Zurich, 8091

Other trials in Switzerland

Czechia1 site

  • Revmatologicky Ustav

    Prague, 128500

Other trials in Czechia

New Zealand1 site

  • Timaru Hospital

    Timaru, 7910

Other trials in New Zealand

Panama1 site

  • Centro de Infusion Marbella; Consultorios Royal Center Num 214

    Panama City, 32400

Other trials in Panama

Slovakia1 site

  • Narodny Ustav Reumatickych Chorob - 34479; Rheumatology

    Piešťany, 921 01

Other trials in Slovakia

Slovenia1 site

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

    Ljubljana, 1000

Other trials in Slovenia

Taiwan1 site

  • Chang Gung Medical Foundation - Kaohsiung; Rheumatology

    Kaohsiung City, 00833

Other trials in Taiwan

About this study

Official title: A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy

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.

Being tested
Leflunomide, Methotrexate, Ocrelizumab, Placebo
Keywords
RA, SCRIPT, anti-CD20, CD20
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LeflunomideDrug

    Oral repeating dose

  • MethotrexateDrug

    Oral or parenteral repeating dose

  • OcrelizumabDrug

    Intravenous repeating dose (200mg)

  • OcrelizumabDrug

    Intravenous repeating dose (500mg)

  • PlaceboDrug

    Intravenous repeating dose

Study groups in NCT00476996
Study groupRoleWhat they receive
Ocrelizumab 200 mg x 2 IV + Non-Biologic DMARD TherapyExperimentalParticipants 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
Receives: Drug: Leflunomide; Drug: Methotrexate; Drug: Ocrelizumab
Ocrelizumab 500 mg x 2 IV + Non-Biologic DMARD TherapyExperimentalParticipants 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
Receives: Drug: Leflunomide; Drug: Methotrexate; Drug: Ocrelizumab
Placebo x 2 IV + Non-Biologic DMARD TherapyPlacebo 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
Receives: Drug: Leflunomide; Drug: Methotrexate; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Weeks 24 and 48

Secondary outcomes (7)

  1. Percentage of Participants With a Major Clinical Response

    Major clinical response was defined as achieving an ACR70 response and maintaining this response for a consecutive period of at least 6 months.

    Measured: Week 48

  2. Percentage of Participants Achieving Disease Activity Score (DAS28) Remission

    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.

    Measured: Weeks 24 and 48

  3. Change in DAS28 From Baseline

    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.

    Measured: Weeks 24 and 48

  4. Percentage of Participants With EULAR Response Rates of Good/ Moderate

    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.

    Measured: Weeks 24 and 48

  5. Percentage of Participants Achieving an ACR50 Response

    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).

    Measured: Weeks 24 and 48

  6. Percentage of Participants Achieving an ACR70 Response

    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.

    Measured: Weeks 24 and 48

  7. Percentage of Participants With a Reduction in the HAQ-DI Score

    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.

    Measured: Weeks 24 and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2007 (estimated)
  2. Study start15 May 2007
  3. Primary completion21 Jan 2010
  4. Study completion14 May 2018

Why it stopped: Recruitment was fully completed for this study; however, the study was terminated during conduct after the primary endpoint analysis was completed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
836 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00476996
Sponsor's protocol ID
ACT3986g
Other IDs
WA20495, 2006-005330-20
Acronym
SCRIPT
Status last verified
Aug 2019
First submitted
18 May 2007
Last updated
12 Aug 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24498318

  • 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.

    PubMed 22389919

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Leflunomide, Methotrexate and Ocrelizumab in people with Rheumatoid Arthritis, run by Genentech, Inc. at 266 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 266 sites in United States, Canada, Germany, Japan, Spain and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses (time frame: Weeks 24 and 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00476996, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.

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SCRIPT Clinical Trial NCT00476996 | AzTrials