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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)

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Leflunomide
Methotrexate
Ocrelizumab
Ocrelizumab
Placebo
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA, SCRIPT, anti-CD20, CD20

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pinnacle Research Group; Llc, Central
  • Rheumatology Associates
  • Rheumatology Associates of North Alabama
  • Arizona Arthritis & Rheumatology Research, Pllc
  • Arthrocare, Arthritis Care and Research, P.C.
  • Catalina Pointe Clinical Research, Inc.
  • Uni of Arizona Health Science Center; Dept of Rheumatology/Immunology
  • CHI St. Vincent Medical Group Hot Springs
  • Little Rock Diagnostic Clinic
  • Allergy & Rheumatology Centre
  • Private Practice
  • Valerius Medical Group & Research Ctr of Greater Long Beach
  • Uni of Southern California School of Medicine
  • Pacific Arthritis Care Center
  • Stanford Uni Medical Center; Divison of Rheumatology
  • Ucsd, Dept of Medicine; Rheumatology
  • San Diego Arthritis Med Clnc
  • East Bay Rheumatology
  • Arthritis Treatment Center of South Bay
  • University of Colorado Cancer Center
  • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
  • Arthritis & Osteoporosis Center P.C.
  • New England Research Associates
  • Rheumatolgy Consultants of Deleware
  • Javed Rheumatology Associates, Inc.
  • Arthritis & Rheumatism; Disease Specialities
  • Jacksonville Center For Clinical Research
  • Arthritis Center Palm Harbor
  • Arthritis Rsrch of Florida, Inc.
  • Sarasota Arthritis Center; Research Dept
  • Center For Arthritis; Research Dept
  • SW Florida Clinical Research
  • Tampa General Hospital; Rheumatology Research Dept
  • Burnette & Silverfield, MDS
  • Florida Medical Center
  • Atlanta Center For Clinical Research.
  • Csi Research, Inc.
  • Marietta Rheumatology Associates, Pc
  • Intermountain Orthopaedics
  • Coeur D'Alene Arthritis Clinic
  • Idaho Arthritis Center
  • Uni of Chicago
  • Evanston Northwestern Healthcare; Rheumatology
  • Quad City Rheumatology, Sc
  • Illinois Bone & Joint Inst.
  • Springfield Clinic
  • Iu Outpatient Clinical Research Facility
  • Diagnostic Rheumatology & Research
  • Medical Specialists Clinical Research Center
  • Physician'S Clinic of Iowa
  • Uni of Kansas Medical Center
  • Center For Arthritis & Osteoporosis
  • Bluegrass Comm Research, Inc.
  • Kentuckiana Center For Better Bone & Joint Healthx
  • Baton Rouge Clinic, Amc
  • Johns Hopkins University; Department of Rheumatology
  • Center For Rheumatology & Bone Research
  • Clinical Pharmacology Study Group
  • Clinsite;Research Division of Integrated Health Associates
  • Rheumatology, P.C.; Medical Arts Building
  • Borgess Research Institute
  • Fiechtner Research Inc
  • Office of Andrew Sulich, Md
  • St Luke's Whiteside Research
  • St. Mary'S Duluth Clinic Health System; Rheumatology Dept
  • St. Paul Rheumatology
  • Park Nicollet Inst. ; Rtrc
  • Jackson Arthritis Clinic
  • North Mississippi Medical Ctr; Internal Medicine Associates
  • David S Rosenberg
  • Clayton Medical Research
  • Physicians Group, LC DBA Rheumatology & Internal Medicine Associates
  • Arthritis Consultants
  • St. John'S Health System Inc.; St. John'S Medical Research
  • Westroads Medical Group
  • Seacoast Arthritis and Osteoporosis Center
  • Nashua Rheumatology - Foundation Medical Partners
  • Mark Fisher Md, Facr, Llc
  • Arthritis Rheumatic & Back Disease Associates
  • The Center of Rheumatology
  • Arthritis & Osteoporosis Center
  • Southern Tier Arthritis & Rheumatism
  • Aair Research Center
  • Andrew Porges Pc
  • Rheumatology Associates of Long Island
  • Asheville Arthritis & Osteoporosis Center, PA
  • Arthritis Associates
  • Metrolina Medical Research
  • Carolina Bone & Joint P.A.
  • Physicians East Pa
  • St. Alexius Medical Center; Arthritis Clinic
  • Deaconess Arthritis Center; Rheumatic Disease Study Group
  • University Hospitals Case Medical Center
  • Stat Research, Inc
  • David Mandel Inc
  • Paramount Medical Research
  • Health Research of Oklahoma, Llc
  • Oklahoma Medical Research Foundation
  • Oklahoma Center For Arthritis Therapy & Research
  • Healthcare Research Consultants
  • Bend Memorial Clinic
  • Pro Research
  • Portland Rheumatology Clinic Llc
  • Providence Arthritis Center
  • East Penn Rheumatology Associates, Pc
  • Arthritis Associates
  • Rheumatology Associates of NW Pa
  • Arthritis Group
  • Advanced Rheumatology & Arthritis Research Center
  • Clinical Research Center of Reading
  • Low Country Research Center
  • Palmetto Clinical Trial Services, LLC
  • Unifour Medical Research Associates
  • Medical Uni of South Carolina
  • Spartanburg Medical Research
  • West Tennessee Research Institute
  • Rheumatology Consultants
  • Arthritis Group
  • Ramesh Gupta - PP
  • Aamr Research Clinic
  • Amarillo Center For Clinical Research
  • Austin Rheumatology Research
  • Walter F. Chase, Md, Pa
  • Arthritis Care & Diagnostic Center
  • Arthritis Care and Research Centre
  • Metroplex Clinical Research
  • Arthritis Centers of Texas
  • Uni of Texas Southwestern Medical Center; Internal Medicine
  • Arthritis & Osteoporosis Associates, LLP
  • Southwest Rheumatology
  • Radiant Research
  • Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases
  • Texas Research Center
  • Uni of Utah Medical Center
  • Arthritis Clinic of Northern Virginia
  • Sentara Medical Group
  • Seattle Rheumatology Associates
  • Arthritis Northwest, Spokane
  • Office of George Krick, Md
  • Tacoma Center For Arthritis Research
  • Vancouver Clinic; Research Dept
  • Clinical Trials Northwest
  • Rheumatic Disease Center
  • Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med
  • Organizacion Medica de Investigacion
  • Inst. de Rehabilitacion Psicofisica; Reumathology
  • CER Instituto Médico; REUMATOLOGÍA
  • Sunshine Coast Rheumatology Research Unit
  • Princess Alexandra Hospital; Rheumatology
  • Royal Perth Hospital; Rheumatology
  • AZ Sint Jan
  • CHU Brugmann (Victor Horta)
  • CHU de Charleroi
  • UZ Gent
  • GHdC Site Saint-Joseph
  • UZ Leuven Gasthuisberg
  • ZNA Jan Palfijn
  • Centro Internacional de Pesquisa; Reumatologia
  • Centro de Estudos em Terapias Inovadoras - CETI
  • Hospital Universitario Clementino Fraga Filho - UFRJ; Reumatologia
  • Hospital das Clinicas - UNICAMP
  • Hospital Abreu Sodre - AACD;Pesquisa Clinica
  • The Governors of the Uni of Alberta; Heritage Medical Research Centre
  • Arthritis Research Centre
  • Manitoba Clinic
  • Wharton Medical Clinic; Burlington
  • Mac Research Inc.
  • K-W Musculoskeletal Research
  • St. Joseph'S Health Care Centre; Rheumatology
  • Credit Valley, Rheumatology
  • The Ottawa Hospital - Riverside Campus; the Arthritis Centre
  • University Health Network; Toronto Western Hospital
  • Hopital Maisonneuve- Rosemont; Rheumatology
  • Institut de Rhumatologie de Montreal
  • Montreal Rheumatic Disease Centre
  • Groupe de Recherche En Rhumatologie Et Maladies Osseuses
  • Clin. de Rhumatologie
  • Royal Uni Hospital; Medicine Dept
  • Revmatologicky Ustav
  • Hopital De Bois Guillaume; Rhumatologie
  • CH Jean Rougier; Rhumato Reed Fonctionnelle
  • Hopital Louis Pasteur; Service De Medecine Interne et de Rhumatologie
  • CH Du Mans; Rhumatologie
  • Hopital B Roger Salengro; Rhumatologie
  • Fondation Hopital Saint Joseph; Rhumatologie
  • Hopital Lapeyronie; Immunologie Rhumatologie
  • Hopital de L'Archet; Rhumatologie
  • Hopital Cochin; Rhumatologie A
  • Hopital Cochin; Rhumatologie B
  • Praxis Dr. med. Reiner Kurthen
  • Schlosspark Klinik; Abt. Rheumatologie
  • Klinik Duisburg; Klinik Für Rheumatologie
  • Endokrinologikum Frankfurt; Rheumatologie & Gynäkologie
  • Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie
  • Internistisches Praxiszentrum Am Krankenhaus Balserische Stiftung; Innere Medizin / Rheumatologie
  • Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik
  • Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie
  • Rheumapraxis PD Dr.med. Bernhard Heilig
  • UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V
  • Fachärzte für Innere Medizin - Rheumatologie - Dr. med. Ino Gao und Dr. med. Maria Anna Meier
  • Klinik der Uni zu Köln; Klinik für Innere Medizin
  • Uniklinik Mainz; I. Medizinische Klinik
  • Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV
  • Rheumapraxis an der Hase
  • Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
  • Orszagos Reumatologiai Es Fizioterapias Intezet
  • Budai Irgalmasrendi Kórház KHT. II. Reumatológia
  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
  • Vas Megye Es Szombathely M.J.V. Markusovszky Korhaza
  • Soroka Medical Center; Reumatology
  • Assaf Harofe; Dept of Medicine B
  • Meir Medical Center; Heamatology Dept
  • Beilinson Medical Center; Rheumatology
  • Sourasky / Ichilov Hospital; Rheumatology
  • Arcispedale Santa Maria Nuova; Reumatologia
  • Università Degli Studi Di Genova - Dimi; Reumatologia
  • Irccs Policlinico San Matteo; Reumatologia Adulti
  • Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia
  • Seihoku Chuoh Hospital; Department Of Rheumatology
  • Univ. of Occupational and Environmental Health; Rheumatology, Clinical Immunology and Medicine
  • National Hospital Organization Kyushu Medical Center; Rheumatology and Internal Medicine
  • Higashihiroshima Memorial Hospital; Rheumatology, Internal Medicine
  • Hokkaido Uni Hospital; Second Department of Internal Medicine
  • Matsubara Mayflower Hospital; Rheumatology
  • Sasebo Chuo Hospital ; Internal Medicine
  • Osaka Minami Medical Center; Rheumatoid Arthritis
  • Saitama Medical University Hospital ; Rheumatology and Applied Immunology
  • Saitama Medical Center/School; Rheumatology, Clinical immunology
  • Seirei Hamamatsu General Hospital; Rheumatology
  • Jichi Medical School Hospital; Rheumatology and Clinical Immunology
  • Tokyo Medical & Dental University; Medicine & Rheumatology
  • Tokyo Women's Medical University
  • Consultorio Privado Dr. Javier Orozco
  • Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
  • Unidad De Enfermedades; Cronico Degenerativas, SC.
  • Clinica San Jose Obregon; Rheumatology
  • Academisch Medisch Centrum; Division of Clinical Immunology & Rheumatology
  • Maxima Medisch Centrum; Rheumatology
  • Timaru Hospital
  • Centro de Infusion Marbella; Consultorios Royal Center Num 214
  • Hospital Alberto Sabogal Sologuren; Remautology
  • Clinica San Felipe; Consultorio de Reumatología
  • Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología
  • Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
  • Wojewodzki Szpital Zespolony; Oddzial Reumatologii
  • Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Narodny Ustav Reumatickych Chorob - 34479; Rheumatology
  • Bolnica dr. Petra Drzaja, Klinicni center Ljubljana; Klinicni oddelek za revmatologijo
  • Hospital Univ. Central de Asturias; Servicio de Reumatologia
  • Corporacio Sanitaria Parc Tauli; Servicio de Reumatologia
  • Hospital de Jerez de la Frontera; Servicio de Reumatologia
  • Hospital Sierrallana; Servicio de Reumatologia
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Reumatologia
  • Hospital de Basurto; Servicio de Reumatologia
  • Hospital Universitario Infanta Cristina; Servicio de Reumatologia
  • Hospital Clinic i Provincial; Servicio de Reumatologia
  • Hospital Universitari de Bellvitge; Servicio de Reumatologia
  • Complejo Asistencial Universitario de Burgos; Servicio de Reumatología
  • Hospital General Universitario de Guadalajara; Servicio de Reumatologia
  • Hospital Universitario 12 de Octubre; Servicio de Reumatologia
  • Hospital Clinico Universitario de Salamanca; Servicio de Reumatologia
  • Uni Hospital Linkoeping; Dept. of Rheumatology
  • Akademiska sjukhuset, Reumatologkliniken
  • CHUV; Hôpital orthopédique, Rhumatologie
  • Universitätsspital Zürich; Klinik für Rheumatologie
  • Chang Gung Medical Foundation - Kaohsiung; Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ocrelizumab 200 mg x 2 IV + Non-Biologic DMARD Therapy

Ocrelizumab 500 mg x 2 IV + Non-Biologic DMARD Therapy

Placebo x 2 IV + Non-Biologic DMARD Therapy

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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.
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.

Full Information

First Posted
May 18, 2007
Last Updated
August 8, 2019
Sponsor
Genentech, Inc.
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00476996
Brief Title
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)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was fully completed for this study; however, the study was terminated during conduct after the primary endpoint analysis was completed.
Study Start Date
May 15, 2007 (Actual)
Primary Completion Date
January 21, 2010 (Actual)
Study Completion Date
May 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
RA, SCRIPT, anti-CD20, CD20

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
836 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab 200 mg x 2 IV + Non-Biologic DMARD Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Ocrelizumab 500 mg x 2 IV + Non-Biologic DMARD Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo x 2 IV + Non-Biologic DMARD Therapy
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Intervention Description
Oral repeating dose
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Oral or parenteral repeating dose
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Intervention Description
Intravenous repeating dose (200mg)
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Intervention Description
Intravenous repeating dose (500mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses
Description
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.
Time Frame
Weeks 24 and 48
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Major Clinical Response
Description
Major clinical response was defined as achieving an ACR70 response and maintaining this response for a consecutive period of at least 6 months.
Time Frame
Week 48
Title
Percentage of Participants Achieving Disease Activity Score (DAS28) Remission
Description
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.
Time Frame
Weeks 24 and 48
Title
Change in DAS28 From Baseline
Description
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.
Time Frame
Weeks 24 and 48
Title
Percentage of Participants With EULAR Response Rates of Good/ Moderate
Description
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.
Time Frame
Weeks 24 and 48
Title
Percentage of Participants Achieving an ACR50 Response
Description
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).
Time Frame
Weeks 24 and 48
Title
Percentage of Participants Achieving an ACR70 Response
Description
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.
Time Frame
Weeks 24 and 48
Title
Percentage of Participants With a Reduction in the HAQ-DI Score
Description
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.
Time Frame
Weeks 24 and 48

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
24498318
Citation
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.
Results Reference
derived
PubMed Identifier
22389919
Citation
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.
Results Reference
derived

Learn more about this trial

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)

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