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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00476996
Other study ID # ACT3986g
Secondary ID WA204952006-0053
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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