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)

Rheumatoid Arthritis Clinical Trial

— SCRIPT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00476996
• Other study ID #: ACT3986g
• Secondary ID: WA204952006-0053
• Status: Terminated
• Phase: Phase 3
• Start date: May 15, 2007
• Est. completion date: May 14, 2018

Study information

• Verified date: August 2019
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 836
• Est. completion date: May 14, 2018
• Est. primary completion date: January 21, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Leflunomide
Oral repeating dose
• Methotrexate
Oral or parenteral repeating dose
• Ocrelizumab
Intravenous repeating dose (200mg)
• Ocrelizumab
Intravenous repeating dose (500mg)
• Placebo
Intravenous repeating dose

Locations

Country	Name	City	State
Argentina	Inst. de Rehabilitacion Psicofisica; Reumathology	Buenos Aires
Argentina	Organizacion Medica de Investigacion	Buenos Aires
Argentina	CER Instituto Médico; REUMATOLOGÍA	Florencio Varela
Australia	Sunshine Coast Rheumatology Research Unit	Maroochydore	Queensland
Australia	Royal Perth Hospital; Rheumatology	Shenton Park	Western Australia
Australia	Princess Alexandra Hospital; Rheumatology	Woolloongabba	Queensland
Belgium	AZ Sint Jan	Brugge
Belgium	CHU Brugmann (Victor Horta)	Bruxelles
Belgium	CHU de Charleroi	Charleroi
Belgium	UZ Gent	Gent
Belgium	GHdC Site Saint-Joseph	Gilly (Charleroi)
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	ZNA Jan Palfijn	Merksem
Brazil	Hospital das Clinicas - UNICAMP	Campinas	SP
Brazil	Centro de Estudos em Terapias Inovadoras - CETI	Curtiba	PR
Brazil	Centro Internacional de Pesquisa; Reumatologia	Goiania	GO
Brazil	Hospital Universitario Clementino Fraga Filho - UFRJ; Reumatologia	Rio de Janeiro	RJ
Brazil	Hospital Abreu Sodre - AACD;Pesquisa Clinica	Sao Paulo	SP
Canada	Wharton Medical Clinic; Burlington	Burlington	Ontario
Canada	The Governors of the Uni of Alberta; Heritage Medical Research Centre	Edmonton	Alberta
Canada	Mac Research Inc.	Hamilton	Ontario
Canada	K-W Musculoskeletal Research	Kitchener	Ontario
Canada	St. Joseph'S Health Care Centre; Rheumatology	London	Ontario
Canada	Credit Valley, Rheumatology	Mississauga	Ontario
Canada	Hopital Maisonneuve- Rosemont; Rheumatology	Montreal	Quebec
Canada	Institut de Rhumatologie de Montreal	Montreal	Quebec
Canada	Montreal Rheumatic Disease Centre	Montreal	Quebec
Canada	The Ottawa Hospital - Riverside Campus; the Arthritis Centre	Ottawa	Ontario
Canada	Groupe de Recherche En Rhumatologie Et Maladies Osseuses	Quebec City	Quebec
Canada	Royal Uni Hospital; Medicine Dept	Saskatoon	Saskatchewan
Canada	University Health Network; Toronto Western Hospital	Toronto	Ontario
Canada	Clin. de Rhumatologie	Trois-rivieres	Quebec
Canada	Arthritis Research Centre	Vancouver	British Columbia
Canada	Manitoba Clinic	Winnipeg	Manitoba
Czechia	Revmatologicky Ustav	Prague
France	Hopital De Bois Guillaume; Rhumatologie	Bois Guillaume
France	CH Jean Rougier; Rhumato Reed Fonctionnelle	Cahors
France	Hopital Louis Pasteur; Service De Medecine Interne et de Rhumatologie	Colmar
France	CH Du Mans; Rhumatologie	Le Mans
France	Hopital B Roger Salengro; Rhumatologie	Lille
France	Fondation Hopital Saint Joseph; Rhumatologie	Marseille
France	Hopital Lapeyronie; Immunologie Rhumatologie	Montpellier
France	Hopital de L'Archet; Rhumatologie	Nice
France	Hopital Cochin; Rhumatologie A	Paris
France	Hopital Cochin; Rhumatologie B	Paris
Germany	Praxis Dr. med. Reiner Kurthen	Aachen
Germany	Schlosspark Klinik; Abt. Rheumatologie	Berlin
Germany	Klinik Duisburg; Klinik Für Rheumatologie	Duisburg
Germany	Endokrinologikum Frankfurt; Rheumatologie & Gynäkologie	Frankfurt
Germany	Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie	Freiburg
Germany	Internistisches Praxiszentrum Am Krankenhaus Balserische Stiftung; Innere Medizin / Rheumatologie	Giessen
Germany	Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik	Hagen
Germany	Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie	Hannover
Germany	Fachärzte für Innere Medizin - Rheumatologie - Dr. med. Ino Gao und Dr. med. Maria Anna Meier	Heidelberg
Germany	Rheumapraxis PD Dr.med. Bernhard Heilig	Heidelberg
Germany	UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V	Heidelberg
Germany	Klinik der Uni zu Köln; Klinik für Innere Medizin	Köln
Germany	Uniklinik Mainz; I. Medizinische Klinik	Mainz
Germany	Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV	München
Germany	Rheumapraxis an der Hase	Osnabrück
Germany	Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie	Würzburg
Hungary	Budai Irgalmasrendi Kórház KHT. II. Reumatológia	Budapest
Hungary	Orszagos Reumatologiai Es Fizioterapias Intezet	Budapest
Hungary	Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék	Debrecen
Hungary	Vas Megye Es Szombathely M.J.V. Markusovszky Korhaza	Szombathely
Israel	Soroka Medical Center; Reumatology	Beer Sheva
Israel	Assaf Harofe; Dept of Medicine B	Beer Yaakov
Israel	Meir Medical Center; Heamatology Dept	Kfar Saba
Israel	Beilinson Medical Center; Rheumatology	Petach Tikva
Israel	Sourasky / Ichilov Hospital; Rheumatology	Tel Aviv
Italy	Università Degli Studi Di Genova - Dimi; Reumatologia	Genova	Liguria
Italy	Irccs Policlinico San Matteo; Reumatologia Adulti	Pavia	Lombardia
Italy	Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia	Pisa	Toscana
Italy	Arcispedale Santa Maria Nuova; Reumatologia	Reggio Emilia	Emilia-Romagna
Japan	Seihoku Chuoh Hospital; Department Of Rheumatology	Aomori
Japan	National Hospital Organization Kyushu Medical Center; Rheumatology and Internal Medicine	Fukuoka
Japan	Univ. of Occupational and Environmental Health; Rheumatology, Clinical Immunology and Medicine	Fukuoka
Japan	Higashihiroshima Memorial Hospital; Rheumatology, Internal Medicine	Hiroshima
Japan	Hokkaido Uni Hospital; Second Department of Internal Medicine	Hokkaido
Japan	Matsubara Mayflower Hospital; Rheumatology	Hyogo
Japan	Sasebo Chuo Hospital ; Internal Medicine	Nagasaki
Japan	Osaka Minami Medical Center; Rheumatoid Arthritis	Osaka
Japan	Saitama Medical Center/School; Rheumatology, Clinical immunology	Saitama
Japan	Saitama Medical University Hospital ; Rheumatology and Applied Immunology	Saitama
Japan	Seirei Hamamatsu General Hospital; Rheumatology	Shizuoka
Japan	Jichi Medical School Hospital; Rheumatology and Clinical Immunology	Tochigi
Japan	Tokyo Medical & Dental University; Medicine & Rheumatology	Tokyo
Japan	Tokyo Women's Medical University	Tokyo
Mexico	Consultorio Privado Dr. Javier Orozco	Guadalajara
Mexico	Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel	Mexicali
Mexico	Unidad De Enfermedades; Cronico Degenerativas, SC.	Mexico
Mexico	Clinica San Jose Obregon; Rheumatology	Obregon
Netherlands	Academisch Medisch Centrum; Division of Clinical Immunology & Rheumatology	Amsterdam
Netherlands	Maxima Medisch Centrum; Rheumatology	Eindhoven
New Zealand	Timaru Hospital	Timaru
Panama	Centro de Infusion Marbella; Consultorios Royal Center Num 214	Panama City
Peru	Hospital Alberto Sabogal Sologuren; Remautology	Callao
Peru	Clinica San Felipe; Consultorio de Reumatología	Lima
Peru	Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología	Lima
Poland	Szpital Uniwersytecki; nr 2 im. Dr J. Biziela	Bydgoszcz
Poland	Wojewodzki Szpital Zespolony; Oddzial Reumatologii	Elblag
Poland	Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1	Szczecin
Slovakia	Narodny Ustav Reumatickych Chorob - 34479; Rheumatology	Piestany
Slovenia	Bolnica dr. Petra Drzaja, Klinicni center Ljubljana; Klinicni oddelek za revmatologijo	Ljubljana
Spain	Hospital Universitario Infanta Cristina; Servicio de Reumatologia	Badajoz
Spain	Hospital Clinic i Provincial; Servicio de Reumatologia	Barcelona
Spain	Hospital Universitari de Bellvitge; Servicio de Reumatologia	Barcelona
Spain	Hospital de Basurto; Servicio de Reumatologia	Bilbao	Vizcaya
Spain	Complejo Asistencial Universitario de Burgos; Servicio de Reumatología	Burgos
Spain	Hospital General Universitario de Guadalajara; Servicio de Reumatologia	Guadalajara
Spain	Hospital de Jerez de la Frontera; Servicio de Reumatologia	Jerez de La Frontera	Cadiz
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Reumatologia	La Coruna	LA Coruña
Spain	Hospital Universitario 12 de Octubre; Servicio de Reumatologia	Madrid
Spain	Hospital Univ. Central de Asturias; Servicio de Reumatologia	Oviedo	Asturias
Spain	Corporacio Sanitaria Parc Tauli; Servicio de Reumatologia	Sabadell	Barcelona
Spain	Hospital Clinico Universitario de Salamanca; Servicio de Reumatologia	Salamanca
Spain	Hospital Sierrallana; Servicio de Reumatologia	Torrelavega	Cantabria
Sweden	Uni Hospital Linkoeping; Dept. of Rheumatology	Linkoeping
Sweden	Akademiska sjukhuset, Reumatologkliniken	Uppsala
Switzerland	CHUV; Hôpital orthopédique, Rhumatologie	Lausanne
Switzerland	Universitätsspital Zürich; Klinik für Rheumatologie	Zürich
Taiwan	Chang Gung Medical Foundation - Kaohsiung; Rheumatology	Kaohsiung
United States	The Center of Rheumatology	Albany	New York
United States	Aamr Research Clinic	Amarillo	Texas
United States	Amarillo Center For Clinical Research	Amarillo	Texas
United States	Clinsite;Research Division of Integrated Health Associates	Ann Arbor	Michigan
United States	Pinnacle Research Group; Llc, Central	Anniston	Alabama
United States	Arthritis Clinic of Northern Virginia	Arlington	Virginia
United States	Asheville Arthritis & Osteoporosis Center, PA	Asheville	North Carolina
United States	Atlanta Center For Clinical Research.	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Austin Rheumatology Research	Austin	Texas
United States	Walter F. Chase, Md, Pa	Austin	Texas
United States	Arthritis & Rheumatism; Disease Specialities	Aventura	Florida
United States	Johns Hopkins University; Department of Rheumatology	Baltimore	Maryland
United States	Baton Rouge Clinic, Amc	Baton Rouge	Louisiana
United States	Arthritis Associates	Belmont	North Carolina
United States	Bend Memorial Clinic	Bend	Oregon
United States	East Penn Rheumatology Associates, Pc	Bethlehem	Pennsylvania
United States	Rheumatology Associates	Birmingham	Alabama
United States	St. Alexius Medical Center; Arthritis Clinic	Bismarck	North Dakota
United States	Intermountain Orthopaedics	Boise	Idaho
United States	Arthritis & Osteoporosis Center	Brooklyn	New York
United States	Arthritis & Osteoporosis Center P.C.	Camden	Connecticut
United States	Physician'S Clinic of Iowa	Cedar Rapids	Iowa
United States	Low Country Research Center	Charleston	South Carolina
United States	Carolina Bone & Joint P.A.	Charlotte	North Carolina
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	Uni of Chicago	Chicago	Illinois
United States	Deaconess Arthritis Center; Rheumatic Disease Study Group	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Coeur D'Alene Arthritis Clinic	Coeur d'Alene	Idaho
United States	Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs	Colorado Springs	Colorado
United States	Csi Research, Inc.	Cumming	Georgia
United States	Arthritis Care & Diagnostic Center	Dallas	Texas
United States	Arthritis Care and Research Centre	Dallas	Texas
United States	Arthritis Centers of Texas	Dallas	Texas
United States	Metroplex Clinical Research	Dallas	Texas
United States	Uni of Texas Southwestern Medical Center; Internal Medicine	Dallas	Texas
United States	Stat Research, Inc	Dayton	Ohio
United States	Seacoast Arthritis and Osteoporosis Center	Dover	New Hampshire
United States	St Luke's Whiteside Research	Duluth	Minnesota
United States	St. Mary'S Duluth Clinic Health System; Rheumatology Dept	Duluth	Minnesota
United States	St. Paul Rheumatology	Eagan	Minnesota
United States	Center For Arthritis & Osteoporosis	Elizabethtown	Kentucky
United States	Arthritis Associates	Erie	Pennsylvania
United States	Rheumatology Associates of NW Pa	Erie	Pennsylvania
United States	Pro Research	Eugene	Oregon
United States	Evanston Northwestern Healthcare; Rheumatology	Evanston	Illinois
United States	David S Rosenberg	Florissant	Missouri
United States	Jackson Arthritis Clinic	Flowood	Mississippi
United States	Palmetto Clinical Trial Services, LLC	Fountain Inn	South Carolina
United States	Rheumatic Disease Center	Glendale	Wisconsin
United States	Physicians East Pa	Greenville	North Carolina
United States	Mark Fisher Md, Facr, Llc	Haddon Heights	New Jersey
United States	Unifour Medical Research Associates	Hickory Grove	South Carolina
United States	CHI St. Vincent Medical Group Hot Springs	Hot Springs	Arkansas
United States	Rheumatology Associates of North Alabama	Huntsville	Alabama
United States	Diagnostic Rheumatology & Research	Indianapolis	Indiana
United States	Iu Outpatient Clinical Research Facility	Indianapolis	Indiana
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Jacksonville Center For Clinical Research	Jacksonville	Florida
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	Rheumatology, P.C.; Medical Arts Building	Kalamazoo	Michigan
United States	Uni of Kansas Medical Center	Kansas City	Kansas
United States	Rheumatology Consultants	Knoxville	Tennessee
United States	Allergy & Rheumatology Centre	La Jolla	California
United States	Portland Rheumatology Clinic Llc	Lake Oswego	Oregon
United States	Fiechtner Research Inc	Lansing	Michigan
United States	Rheumatolgy Consultants of Deleware	Lewes	Delaware
United States	Bluegrass Comm Research, Inc.	Lexington	Kentucky
United States	Little Rock Diagnostic Clinic	Little Rock	Arkansas
United States	Private Practice	Long Beach	California
United States	Valerius Medical Group & Research Ctr of Greater Long Beach	Los Alamitos	California
United States	Pacific Arthritis Care Center	Los Angeles	California
United States	Uni of Southern California School of Medicine	Los Angeles	California
United States	Kentuckiana Center For Better Bone & Joint Healthx	Louisville	Kentucky
United States	Arthritis & Osteoporosis Associates, LLP	Lubbock	Texas
United States	Marietta Rheumatology Associates, Pc	Marietta	Georgia
United States	David Mandel Inc	Mayfield	Ohio
United States	Arthritis Group	Memphis	Tennessee
United States	Ramesh Gupta - PP	Memphis	Tennessee
United States	Idaho Arthritis Center	Meridian	Idaho
United States	Arizona Arthritis & Rheumatology Research, Pllc	Mesa	Arizona
United States	Arthrocare, Arthritis Care and Research, P.C.	Mesa	Arizona
United States	Southwest Rheumatology	Mesquite	Texas
United States	Paramount Medical Research	Middleburg Heights	Ohio
United States	Park Nicollet Inst. ; Rtrc	Minneapolis	Minnesota
United States	Quad City Rheumatology, Sc	Moline	Illinois
United States	Illinois Bone & Joint Inst.	Morton Grove	Illinois
United States	Medical Specialists Clinical Research Center	Munster	Indiana
United States	Nashua Rheumatology - Foundation Medical Partners	Nashua	New Hampshire
United States	Javed Rheumatology Associates, Inc.	Newark	Delaware
United States	Sentara Medical Group	Norfolk	Virginia
United States	Medical Uni of South Carolina	North Charleston	South Carolina
United States	Health Research of Oklahoma, Llc	Oklahoma City	Oklahoma
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Southern Tier Arthritis & Rheumatism	Olean	New York
United States	Westroads Medical Group	Omaha	Nebraska
United States	Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med	Onalaska	Wisconsin
United States	Arthritis Center Palm Harbor	Palm Harbor	Florida
United States	Arthritis Rsrch of Florida, Inc.	Palm Harbor	Florida
United States	Stanford Uni Medical Center; Divison of Rheumatology	Palo Alto	California
United States	Arthritis Group	Philadelphia	Pennsylvania
United States	Providence Arthritis Center	Portland	Oregon
United States	Aair Research Center	Rochester	New York
United States	Andrew Porges Pc	Roslyn	New York
United States	Office of Andrew Sulich, Md	Saint Clair Shores	Michigan
United States	Arthritis Consultants	Saint Louis	Missouri
United States	Clayton Medical Research	Saint Louis	Missouri
United States	Physicians Group, LC DBA Rheumatology & Internal Medicine Associates	Saint Louis	Missouri
United States	Uni of Utah Medical Center	Salt Lake City	Utah
United States	Radiant Research	San Antonio	Texas
United States	Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases	San Antonio	Texas
United States	San Diego Arthritis Med Clnc	San Diego	California
United States	Ucsd, Dept of Medicine; Rheumatology	San Diego	California
United States	East Bay Rheumatology	San Leandro	California
United States	Sarasota Arthritis Center; Research Dept	Sarasota	Florida
United States	Seattle Rheumatology Associates	Seattle	Washington
United States	Rheumatology Associates of Long Island	Smithtown	New York
United States	Center For Arthritis; Research Dept	South Miami	Florida
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Arthritis Northwest, Spokane	Spokane	Washington
United States	Springfield Clinic	Springfield	Illinois
United States	St. John'S Health System Inc.; St. John'S Medical Research	Springfield	Missouri
United States	Texas Research Center	Sugar Land	Texas
United States	Office of George Krick, Md	Tacoma	Washington
United States	Tacoma Center For Arthritis Research	Tacoma	Washington
United States	Burnette & Silverfield, MDS	Tampa	Florida
United States	SW Florida Clinical Research	Tampa	Florida
United States	Tampa General Hospital; Rheumatology Research Dept	Tampa	Florida
United States	Arthritis Treatment Center of South Bay	Torrance	California
United States	New England Research Associates	Trumbull	Connecticut
United States	Catalina Pointe Clinical Research, Inc.	Tucson	Arizona
United States	Uni of Arizona Health Science Center; Dept of Rheumatology/Immunology	Tucson	Arizona
United States	Healthcare Research Consultants	Tulsa	Oklahoma
United States	Oklahoma Center For Arthritis Therapy & Research	Tulsa	Oklahoma
United States	North Mississippi Medical Ctr; Internal Medicine Associates	Tupelo	Mississippi
United States	Vancouver Clinic; Research Dept	Vancouver	Washington
United States	Arthritis Rheumatic & Back Disease Associates	Voorhees	New Jersey
United States	Advanced Rheumatology & Arthritis Research Center	Wexford	Pennsylvania
United States	Center For Rheumatology & Bone Research	Wheaton	Maryland
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts
United States	Clinical Research Center of Reading	Wyomissing	Pennsylvania
United States	Clinical Trials Northwest	Yakima	Washington
United States	Florida Medical Center	Zephyrhills	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	Roche Pharma AG

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 48
Secondary	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.	Weeks 24 and 48
Secondary	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.	Weeks 24 and 48
Secondary	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.	Weeks 24 and 48
Secondary	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).	Weeks 24 and 48
Secondary	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.	Weeks 24 and 48
Secondary	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.	Weeks 24 and 48