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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01885078
Other study ID # 14060
Secondary ID I4V-MC-JADY2012-
Status Completed
Phase Phase 3
First received
Last updated
Start date June 27, 2013
Est. completion date November 12, 2020

Study information

Verified date April 2022
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study provides 7 years of additional treatment with baricitinib.


Recruitment information / eligibility

Status Completed
Enrollment 2877
Est. completion date November 12, 2020
Est. primary completion date November 12, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705) Exclusion Criteria: - Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered - Have a known hypersensitivity to baricitinib or any component of this investigational product - Had investigational product permanently discontinued at any time during a previous baricitinib study - Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study - Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Baricitinib
Administered orally
Placebo
Administered orally

Locations

Country Name City State
Argentina Hospital Italiano Regional del Sur Bahia Blanca Buenos Aires
Argentina CENIT Centro de Neurociencias, Investigación y Tratamiento Caba Ciudad Autonoma Buenos Aires
Argentina Instituto Centenario Caba Ciudad Autonoma De Buenos Aire
Argentina Consultorios Asociados de Endocrinologia Ciudad Autonoma Buenos Aires
Argentina Atencion Integral en Reumatología Ciudad Autonoma de Buenos Aire Buenos Aires
Argentina CCBR Buenos Aires Ciudad Autonoma de Buenos Aire
Argentina CEMIC Saavedra Ciudad Autonoma de Buenos Aire
Argentina Centro de Medicina Familiar Mindout Research Ciudad Autonoma de Buenos Aire
Argentina Centro De Osteopatias - Comlit Ciudad Autonoma de Buenos Aire
Argentina CENUDIAB Ciudad Autonoma de Buenos Aire
Argentina Consultorios Reumatologicos Pampa Ciudad Autonoma de Buenos Aire
Argentina Hospital Ramos Mejia Ciudad Autonoma de Buenos Aire
Argentina Organizacion Medica de Investigacion - OMI Ciudad Autonoma de Buenos Aire
Argentina Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC Cordoba
Argentina Hospital Italiano de Cordoba Cordoba
Argentina Hospital Privado Centro Medico de Cordoba SA Cordoba
Argentina Instituto Medico Strusberg Cordoba
Argentina Centro de Investigaciones Medicas Mar del Plata Mar del Plata Buenos Aires
Argentina Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires
Argentina CER Instituto Medico Quilmes Buenos Aires
Argentina Instituto de Investigaciones Clinicas Quilmes Quilmes Buenos Aires
Argentina Centro de Enfermedades del Higado y Aparato Digestivo Rosario Santa Fe
Argentina Instituto CAICI SRL Rosario Santa Fe
Argentina Instituto Medico de Alta Complejidad San Isidro San Isidro Buenos Aires
Argentina Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan San Juan
Argentina Centro Medico Privado de Reumatologia SAN M. DE Tucuman Tucumán
Argentina CIR Centro de Investigacions Reumatologicas San Miguel de Tucuman Tucuman
Australia Emeritus Research Camberwell Victoria
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia St Vincents Hospital Melbourne Fitzroy Victoria
Australia Canberra Hospital Garran Australian Capital Territory
Australia Combined Rheumatology Practice (CRP) Kogarah New South Wales
Australia Coast Joint Care Maroochydore Queensland
Austria Universitätsklinikum Graz Graz Steiermark
Austria Rheuma Zentrum Favoriten GmbH Wien
Belgium Cliniques Universitaires Saint-Luc Bruxelles Brussel
Belgium Reuma Clinic, Locatie Jaarbeurslaan Genk
Belgium Universitair Ziekenhuis Gent Gent Oost-Vlaanderen
Belgium ZNA Jan Palfijn Merksem Vlaams Gewest
Belgium CHU Ambroise Pare Mons
Brazil Associacao de Assistencia a Crianca Deficiente (AACD) Sao Paulo São Paulo
Brazil CEPIC - Centro Paulista de Investigação Clínica São Paulo SP
Brazil CPCLIN São Paulo SP
Canada Rheumatology Research Associates Group Edmonton Alberta
Canada The Medical Arts Health Research Group Kelowna British Columbia
Canada KW Musculoskeletal Research Inc Kitchener Ontario
Canada The Ottawa Hospital Ottawa Ontario
Canada Center de Recherche St Louis Quebec City Quebec
Canada Saskatoon Osteoporosis Centre Saskatoon Saskatchewan
Canada Niagara Peninsula Arthritis Centre, Inc. St. Catherines Ontario
Canada Mount Sinai Hospital Toronto Ontario
Canada UHN-Toronto Western Hospital Toronto Ontario
Canada Centre de Recherche Musculo-Squelettique Trois-Rivieres Quebec
Canada PerCuro Clinical Research Ltd. Victoria British Columbia
Canada Manitoba Clinic Medical Corporation Winnipeg Manitoba
China China-Japan Friendship Hospital Beijing
China Peking University People's Hospital Beijing Beijing
China Afflilated Hospital of Bengbu Medical College Bengbu Anhui
China The Second Xiangya Hospital of Central South University Changsha Hunan
China Xiangya Hospital, Central South University Changsha Hunan
China West China Hospital Sichuan University Cheng Du Sichuan
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Anhui Provincial Hospital Hefei Anhui
China The First Affiliate Hospital of AnHui Medical University Hefei Anhui
China Qilu Hospital of Shandong University Jinan Shandong
China First Affiliated Hospital of Kunming Medical University Kunming Yunnan
China Ningbo First Hospital Ningbo Zhejiang
China Pingxiang People's Hospital Pingxiang Jiangxi
China Shanghai Guanghua Hospital Shanghai
China Zhongshan Hospital, Fudan University Shanghai Shanghai
China 1st Hospital affiliated to Medical College of Shantou Univer Shantou Guangzhou
China YanCheng First People's Hospital Yancheng Jiangsu
China ZhuZhou Central Hospital ZhuZhou Hunan
Croatia KBC Osijek Osijek
Croatia Klinicka bolnica Sveti Duh Zagreb
Croatia Poliklinika K-centar Zagreb
Czechia Revmaclinic, s.r.o Brno
Czechia Revmatologicka ambulance Bruntal
Czechia ELIMATES BRNO s.r.o. Revmatologicka ambulance Hustopece
Czechia Artroscan, s.r.o. Ostrava
Czechia Vesalion s.r.o. Ostrava
Czechia ARTHROHELP s.r.o. Pardubice
Czechia Revmatologicky ustav Praha 2 Praha, Hlavní Mešto
Czechia Medical Plus Uherske Hradiste
Czechia PV Medical Services s.r.o. Zlin
Denmark Frederiksberg Hospital Frederiksberg Hovedstaden
Denmark Copenhagen University Hospital Glostrup Hovedstaden
Denmark Odense Universitetshospital Odense C Syd
France Centre Hospitalier Jean Rougier Cahors CEDEX 9
France Hôpital Trousseau, CHRU de Tours Chambray-lès-Tours
France CHRU de Limoges Hopital Dupuytren Limoges CEDEX Haute-Vienne
France Hôpital Arnaud de Villeneuve - CHU Montpellier Montpellier Cedex 5
France Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes Cedex 1
France Nouvel Hôpital Orléans La Source Orleans CEDEX 2
France Hopital de la Pitie Salpetriere Paris CEDEX 13
France Hopital Cochin Paris CEDEX 14
France CHU la Miletrie Poitiers
France CHU Rennes/Hopital Sud Rennes CEDEX 2
France Hopital Bel Air Thionville
Germany Internistisch-rheumatologische Praxisgemeinschaft Bayreuth Bayreuth Bayern
Germany Charité Campus Virchow-Klinikum Berlin
Germany Städtisches Klinikum Dresden-Friedrichstadt Dresden Sachsen
Germany Immunologisches Zentrum Vogelsang-Gommern GmbH Gommern Sachsen-Anhalt
Germany Schön Klinik Hamburg Eilbek Hamburg
Germany Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg
Germany Universitätsklinikum Köln Köln Nordrhein-Westfalen
Germany Klinikum der Universität München München Bayern
Germany Universitätsklinikum Würzburg A. ö. R. Würzburg Bayern
Greece Hippokration Hospital of Athens Athens Attiki
Greece University General Hospital of Heraklion Heraklion Crete
Greece General Hospital of Attica KAT Kifissia Attiki
Greece University General Hospital of Larissa Larissa
Hungary Dr. Rethy Pal Korhaz es Rendelointezet Bekescsaba Bekes
Hungary Orszagos Reumatologiai es Fizioterapias Intezet Budapest
Hungary Revita Clinic Budapest Pest
Hungary Kiskunhalasi Semmelweis Korhaz Kiskunhalas Bacs-Kiskun
Hungary Szabolcs-Szatmar-Bereg M-i Korhazak es Egyetemi Oktatokorhaz Nyiregyhaza Szabolcs-Szatmar-Bereg
Hungary Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar Fejer
Hungary Csolnoky Ferenc Korhaz Veszprem
India Shalby Hospital Ahmedabad Gujarat
India Manipal Centre for Clinical Research (MCCR) Attavar, Mangalore Karnataka
India M S Ramaiah Medical College Hospital Bangalore Karnataka
India St. John Medical College & Hospital Bangalore Karnataka
India KLES Prabhakar Kore Hospital and Medical Research Centre Belgaum Karnataka
India Medanta-The Medicity Gurgaon Haryana
India Care Hospital Hyderabad Telangana
India Sumana Hospital Hyderabad Andhra Pradesh
India Shri Nidan Hospital & Hope Fertility Centre Jaipur Rajasthan
India Apollo Gleneagles Hospitals Kolkata Kolkata West Bengal
India IPGMER and SSKM Hospital Kolkata West Bengal
India CSM Medical University Lucknow Uttar Pradesh
India Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst. Mumbai Maharashtra
India Indraprastha Apollo Hospital New Delhi Delhi
India Sir Ganga Ram Hospital New Delhi Delhi
India Krishna Institute of Medical Sciences Ltd. Secunderabad Telengana
Israel Barzilai Medical Center Ashkelon HaDarom
Israel Bnai Zion Medical Center Haifa
Israel Carmel Hospital Haifa ?eifa
Israel Rambam Health Care Campus Haifa
Israel Hadassah Medical Center Jerusalem
Israel Meir Medical Center Kfar Saba
Israel Rabin Medical Center Petah Tiqva
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Israel Assaf Harofeh Medical Center Zerifin
Italy Azienda Ospedaliera Universitaria Careggi Firenze
Italy Ospedale Luigi Sacco Milano
Italy Stabilimento Ospedaliero Santa Chiara Pisa
Italy Polic.Umberto I -Univ. La Sapienza Roma
Italy Ospedale San Giovanni Bosco Torino
Italy Ospedale Policlinico Giambattista Rossi, Borgo Roma Verona
Japan Tokyo Women's Medical University East Medical Center Arakawa-ku Tokyo
Japan Katayama Clinic Asahikawa Hokkaido
Japan National Hospital Organization Asahikawa Medical Center Asahikawa Hokkaido
Japan National Chiba-East-Hospital Chuo-ku Chiba
Japan St. Lukes International Hospital Chuo-Ku Tokyo
Japan Kondo Clinic for Rheumatism and Orthopaedics Fukuoka
Japan Medical Co. LTA Fukuoka Mirai Hospital Fukuoka
Japan National Hospital Organization Kyushu Medical Center Fukuoka
Japan Shono Rheumatism Clinic Fukuoka
Japan Fujimori Clinic Hachioji Tokyo
Japan PS Clinic Hakata-ku Fukuoka
Japan Seirei Hamamatsu General Hospital Hamamatsu Shizuoka
Japan Hiroshima Clinic Hiroshima
Japan Hiroshima Rheumatology Clinic Hiroshima
Japan Oasis Clinic Hitachi Ibaragi
Japan Aso Iizuka Hospital Iizuka Fukuoka
Japan Tokai University Hospital Isehara Kanagawa
Japan Nihon University Itabashi Hospital Itabashi-ku Tokyo
Japan Kagoshima Red Cross Hospital Kagoshima
Japan Matsubara Mayflower Hospital Kato Hyogo
Japan Saitama Medical Center Kawagoe Saitama
Japan Kaneko Clinic Kawaguchi Saitama
Japan St Marianna University School of Medicine Hospital Kawasaki Kanagawa
Japan Yoshitama Clinic Rheumatology & Internal Medicine Kirishima Kagoshima
Japan Kagawa University Hospital Kita-gun Kagawa
Japan University of Occupational and Enviromental Health Kitakyushu Fukuoka
Japan Kumamoto Saishun Medical Center Koshi Kumamoto
Japan Kumamoto Orthopedic Hospital Kumamoto
Japan Kumamoto Rheumatology Clinic Kumamoto
Japan Kumamoto Shinto General hospital Kumamoto
Japan Matsudo City Hospital Matsudo Chiba
Japan National Tokyo Medical Center Meguro-Ku Tokyo
Japan Kyorin University Hospital Mitaka Tokyo
Japan Komagamine Orthopedic and Rheumatology Clinic Morioka Iwate
Japan Yoshida Orthopaedic and Rheumatic Clinic Morioka Iwate
Japan Nagano Red Cross Hospital Nagano
Japan Nagaoka Red Cross Hospital Nagaoka Niigata
Japan Nagasaki Medical Hospital of Rheumatology Nagasaki
Japan The Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki
Japan Chubu-Rosai Hospital Nagoya Aichi
Japan Nagoya Medical Center Nagoya Aichi
Japan Nagoya University Hospital Nagoya Aichi
Japan Chibaken Saiseikai Narashino Hospital Narashino Chiba
Japan Oribe Clinic Rheumatism and Medicine Oita
Japan Japanese Red Cross Okayama Hospital Okayama
Japan Okayama Saiseikai General Hospital Outpatient Center Okayama
Japan Okayama University Hospital Okayama
Japan National Nagasaki Medical Center Omura Nagasaki
Japan Yokota Clinic for Rheumatology Osaka
Japan Hokkaido Medical Center for Rheumatic Diseases Sapporo Hokkaido
Japan Hokkaido University Hospital Sapporo Hokkaido
Japan NTT East Japan Sapporo Hospital Sapporo Hokkaido
Japan Sagawa Akira Rheumatology Clinic Sapporo Hokkaido
Japan Sasebo Chuo Hospital Sasebo Nagasaki
Japan Azuma Rheumatology Clinic Sayama Saitama
Japan Osafune Clinic Setouchi Okayama
Japan Niigata Rheumatic Center Shibata Niigata
Japan Jichi Medical University Hospital Shimotsuke Tochigi
Japan Keio University Hospital Shinjuku-Ku Tokyo
Japan JA-Shizuoka Shizuoka-Kosei General Hospital Shizuoka
Japan Shizuoka Rheumatism orthopedic Rehabilitation Hospital Shizuoka
Japan Miyasato Clinic Shunan Yamaguchi
Japan Takaoka Rheumatic Orthopedic CL Takaoka Toyama
Japan Takarazuka City Hospital Takarazuka Hyogo
Japan Hirose Clinic Tokorozawa Saitama
Japan Tomishiro Central Hospital Tomigusuku Okinawa
Japan Tsukuba University Hospital Tsukuba Ibaraki
Japan NHO Ureshino Medical Center Ureshino Saga
Japan Yokkaichi Hazu Medical Center Yokkaichi Mie
Japan Yokohama City University Hospital Yokohama Kanagawa
Japan Yokohama Minami Kyosai Hospital Yokohama Kanagawa
Japan Yokohama Rosai Hospital Yokohama Kanagawa
Japan Tsuzuki Azuma Clinic: Primary care and Rheumatology Yokohama-City Kanagawa
Japan Shimoshizu National Hospital Yotsukaido Chiba
Korea, Republic of Chungnam National University Hospital Dae Jeon Korea
Korea, Republic of Daegu Catholic University Medical Center Daegu Korea
Korea, Republic of Kyung Pook National University Hospital Daegu Korea
Korea, Republic of Chungnam National University Hospital Daejeon Korea
Korea, Republic of Chonnam National University Hospital Gwangju Korea
Korea, Republic of Gachon University Gil Medical Center Incheon Korea
Korea, Republic of Inha University Hospital Incheon Korea
Korea, Republic of Asan Medical Center Seoul Korea
Korea, Republic of Catholic University of Korea Yeouido St. Mary's Hospital Seoul Korea
Korea, Republic of Hanyang University Medical Center Seoul Korea
Korea, Republic of Konkuk University Medical Center Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Kyung Hee University Hospital Seoul Korea
Korea, Republic of Kyunghee University Hospital at Gangdong Seoul Korea
Korea, Republic of Seoul Municipal Boramae Hospital Seoul Korea
Korea, Republic of Seoul National University Hospital Seoul Korea
Korea, Republic of Seoul St. Mary's Hospital Seoul Korea
Korea, Republic of Ajou University Hospital Suwon Gyeonggi-do
Latvia Rheumatology Practice in Jaunliepaja Primary Health Care Cen Liepaja
Latvia Pauls Stradins Kliniska Universitates Slimnica Riga
Latvia Dr. Sarmite Saleniece Valmiera
Lithuania Dr. Kildos Klinika Kaunas
Lithuania Klaipedos Universitetine Ligonine Klaipeda
Lithuania Respublikine Siauliu Ligonine Siauliai
Mexico Centro de Estudios de Investigacion Basica y Clinica, S.C. Guadalajara Jalisco
Mexico Centro Integral en Reumatologia SA de CV Guadalajara Jalisco
Mexico Clinica de Investigacion en Reumatologia y Obesidad S. C. Guadalajara Jalisco
Mexico Private Service Guadalajara Jalisco
Mexico Unidad de Investigacion en Enfermedades Cronico Degenerative Guadalajara Jalisco
Mexico Centro Medico de las Americas Merida Yucatan
Mexico Medical Care and Research, S.A. de C.V. Merida Yucatan
Mexico Ctro Inv en Artritis y Osteoporosis SC Mexicali Baja California
Mexico Comite Mexicano para la Prevencion de la Osteoporosis A.C. Mexico City Distrito Federal
Mexico Hospital de Jesus I.A.P. Mexico City Distrito Federal
Mexico Mentrials S.A. de C.V Mexico City Distrito Federal
Mexico Mexico Centre for Clinical Research SA de CV Mexico City Distrito Federal
Mexico RM Pharma Specialists S.A. de C.V. Mexico City Distrito Federal
Mexico Hospital Universitario de Monterrey Monterrey Nuevo Leon
Mexico Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C. San Luis Potosi
Mexico Centro de Investigacion del Noroeste Tijuana Baja California
Netherlands Ziekenhuisgroep Twente, Almelo Almelo
Poland Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej Bydgoszcz
Poland Ambulatorium Barbara Bazela Elblag
Poland Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie
Poland Centrum Medyczne Pratia Katowice Katowice
Poland Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna Lodz
Poland NZOZ Lecznica MAK-MED s.c. Nadarzyn
Poland Centrum Medyczne AMED Warszawa
Poland REUMATIKA - Centrum Reumatologii Warszawa
Portugal Hospital Garcia da Orta Almada
Portugal Instituto Portugues de Reumatologia Lisbon
Portugal Hospital do Conde de Bertiandos Ponte de Lima
Portugal Hospital de Sao Joao E.P.E. Porto
Portugal Hospital Geral de Santo Antonio Porto
Puerto Rico Ramon L. Ortega Colon Carolina
Puerto Rico Ponce School of Medicine CAIMED Center Ponce
Puerto Rico Barbara Diaz Hernandez San Juan
Puerto Rico Latin Clinical Trial Center San Juan
Puerto Rico Mindful Medical Research San Juan
Romania SC DUO Medical S.R.L Rheumatology Bucuresti
Romania Spitalul Clinic "Dr. Ioan Cantacuzino" Bucuresti
Romania Spitalul Clinic Sf Maria Bucuresti Bucuresti
Romania Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta Constanta
Romania Spitalul Clinic de Recuperare Iasi Iasi
Romania Spital Clinic Judetean de Urgenta Tg.Mures Tg.Mures Mures
Russian Federation Family Clinic No 4 Korolev
Russian Federation City Clinical Hospital 1 named after N.I. Pirogov Moscow
Russian Federation First Moscow State Medical University Moscow
Russian Federation V.A. Nasonova Research Institute of Rheumatology Moscow
Russian Federation Ryazan Regional Clinincal Cardiology Dispensary Ryazan
Russian Federation Gbuz Lokb Saint-Petersburg Leningradskaya Oblast'
Russian Federation Saratov Regional Clinical Hospital Saratov
Russian Federation Clinical Rheumatology Hospital # 25 St. Petersburg
Russian Federation GUZ UOKB Ul'yanovsk Ul'yanovskaya Oblast
Russian Federation Clinical Emergency Hospital N.V.Solovyov Yaroslavl
Slovakia Nestatna reumatologicka ambulancia Bratislava
Slovakia ROMJAN s.r.o. Bratislava
Slovakia Reumacentrum s.r.o. Partizanske
Slovakia REUMED s.r.o. Spisska Nova Ves
Slovakia LERAM s.r.o. Topolcany
Slovenia Bolnisnica Dr. P. Drzaja UKCLJ Ljubljana
South Africa Arthritis Clinical Trial Centre Cape Town Western Cape
South Africa Precise Clinical Solutions (Pty) Ltd Durban KZ-Natal
South Africa Saint Augustine's Hospital Durban KZ-Natal
South Africa Netcare Greenacres Hospital Port Elizabeth Eastern Cape
South Africa Somerset West Trial Centre Somerset West Western Cape
South Africa Winelands Medical Research Centre Stellenbosch Western Cape
Spain Hospital Clinic I Provincial Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital De Basurto Bilbao Vizcaya
Spain Hospital Universitario Getafe Getafe Madrid
Spain Hospital Marina Baixa La Vila Joiosa Alicante
Spain Corporacion Sanitaria Parc Tauli Sabadell Barcelona
Spain Hospital Universitario Marques De Valdecilla Santander Cantabria
Spain Hospital Quiron Infanta Luisa Sevilla Andalucía
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Universitario La Fe de Valencia Valencia
Sweden Sahlgrenska Universitetssjukhuset Göteborg Gothenburg
Sweden Reumatologiska Kliniken Skånes universitetssjukhus Malmö Malmo
Switzerland HFR Fribourg - Hôpital Cantonal Fribourg
Switzerland CHUV Centre Hospitalier Universitaire Vaudois Lausanne Vaud
Switzerland Universitätsspital Zürich Zürich
Taiwan Chang Gung Memorial Hospital - Kaohsiung Branch Kaohsiung City
Taiwan Tri-Service General Hospital Neihu Taipei
Taiwan China Medical University Hospital Taichung City
Taiwan Chung Shan Medical University Hospital Taichung City
Taiwan Cathay General Hospital Taipei City
Taiwan MacKay Memorial Hospital Taipei City
Taiwan National Taiwan University Hospital Taipei City
Taiwan Taipei Veterans General Hospital Taipei City
Taiwan Chi-Mei Medical Center Yongkang City
Turkey Trakya University Edirne
United Kingdom Basingstoke and North Hampshire Hospital Basingstoke Hampshire
United Kingdom St Lukes Hospital Bradford West Yorkshire
United Kingdom Addenbrookes Hospital Cambridge Cambridgeshire
United Kingdom Guy's Hospital London Surrey
United Kingdom Whipps Cross University Hospital London Surrey
United Kingdom Northumbria Healthcare NHS Foundation Trust Newcastle upon Tyne Tyneside
United Kingdom Southampton General Hospital Southampton Hants
United States The Center for Rheumatology Albany New York
United States Albuquerque Clinical Trials, Inc. Albuquerque New Mexico
United States Asheville Rheumatology & Osteoporosis Research Assoc, PA Asheville North Carolina
United States East Penn Rheumatology Associates Bethlehem Pennsylvania
United States Intermountain Research Center Boise Idaho
United States Western Washington Arthritis Clinic Bothell Washington
United States Boulder Medical Center Boulder Colorado
United States Orthopedic Research Institute Boynton Beach Florida
United States New England Research Associates Bridgeport Connecticut
United States Arthritis and Osteoporosis Consultants of the Carolinas Charlotte North Carolina
United States Center for Arthritis and Rheumatic Diseases, PC Chesapeake Virginia
United States University of Missouri Columbia Missouri
United States Klein and Associates MD, PA Cumberland Maryland
United States Pioneer Research Solutions Cypress Texas
United States Metroplex Clinical Research Center Dallas Texas
United States Clinical Research Center of CT/NY Danbury Connecticut
United States Denver Arthritis Clinic - Lowry Denver Colorado
United States Altoona Center For Clinical Research Duncansville Pennsylvania
United States Arthritis and Osteporosis Treatment and Research Center Flowood Mississippi
United States Rheumatology and Immunotherapy Center Franklin Wisconsin
United States (AOA) Arthritis & Osteoporosis Associates Freehold New Jersey
United States Valley Endocrine, Fresno Fresno California
United States Arizona Arthritis & Rheumatology Research, PLLC Glendale Arizona
United States West Michigan Rheumatology Grand Rapids Michigan
United States Drug Trials of America Hartsdale New York
United States Diagnostic Rheumatology and Research Indianapolis Indiana
United States Goldpoint Clinical Research LLC Indianapolis Indiana
United States Indiana University Health Indianapolis Indiana
United States Borgess Rheumatology Kalamazoo Michigan
United States Kadlec Clinic Rheumatology Kennewick Washington
United States Allergy and Rheumatology Medical Clinic Inc La Jolla California
United States Advanced Rheumatology, PC Lansing Michigan
United States Office: Dr. Fiechtner, Justus Lansing Michigan
United States Dr. George Timothy Kelly Las Vegas Nevada
United States Accurate Clinical Research League City Texas
United States Delaware Arthritis Lewes Delaware
United States Arthritis & Osteoporosis Associates LLP Lubbock Texas
United States Arizona Arthritis & Rheumatology Associates, P. C. Mesa Arizona
United States Paramount Medical Research Middleburg Heights Ohio
United States Carolina Rheumatology and Neurology Associates Myrtle Beach South Carolina
United States Medallion Clinical Research Institute Naples Florida
United States Sun Coast Clinical Research, Inc New Port Richey Florida
United States Health Research of Oklahoma Oklahoma City Oklahoma
United States Omega Research Consultants Orlando Florida
United States Rheumatology Associates of Central Florida Orlando Florida
United States Desert Medical Advances Palm Desert California
United States Arthritis Research of Florida Palm Harbor Florida
United States Stanford University Hospital Palo Alto California
United States Sun Valley Arthritis Center, LTD Peoria Arizona
United States Arthritis Group Philadelphia Pennsylvania
United States Arizona Research Center Phoenix Arizona
United States Oregon Health and Science University Portland Oregon
United States Allergy Asthma Immunology of Rochester, AAIR Research Ctr Rochester New York
United States Arthritis Consultants, Inc. Saint Louis Missouri
United States Clayton Medical Research Saint Louis Missouri
United States Pacific Arthritis Center Santa Maria California
United States West Broward Rheumatology Associates, Inc Tamarac Florida
United States AdventHealth Medical Group Tampa Florida
United States Tampa Medical Group, P.A. Tampa Florida
United States Ocean Rheumatology, PA Toms River New Jersey
United States University of Arizona Tucson Arizona
United States Healthcare Research Consultant Tulsa Oklahoma
United States Inland Rheumatology & Osteoporosis Medical Group Upland California
United States The Vancouver Clinic Vancouver Washington
United States Deerbrook Medical Associates Vernon Hills Illinois
United States Accurate Clinical Research Webster Texas
United States Clinical Research Center of Reading,LLC Wyomissing Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Experienced Adverse Events (AEs) or Serious AE An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%.
An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason
A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Baseline through 84 Months
Secondary Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20 ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had =20% improvement from baseline in both 68 tender and 66 swollen joint counts and =20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100 Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20 ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had =20% improvement from baseline in both 68 tender and 66 swollen joint counts and =20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100 Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20 ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had =20% improvement from baseline in both 68 tender and 66 swollen joint counts and =20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100 Year 5 after entry into JADY
Secondary Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50 ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had =50% improvement from baseline in both 68 tender and 66 swollen joint counts and =50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100 Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50 ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had =50% improvement from baseline in both 68 tender and 66 swollen joint counts and =50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100 Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50 ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had =50% improvement from baseline in both 68 tender and 66 swollen joint counts and =50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100 Year 5 after entry into JADY
Secondary Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70 ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had =70% improvement from baseline in both 68 tender and 66 swollen joint counts and =70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100 Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70 ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had =70% improvement from baseline in both 68 tender and 66 swollen joint counts and =70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100 Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70 ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had =70% improvement from baseline in both 68 tender and 66 swollen joint counts and =70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100 Year 5 after entry into JADY
Secondary Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) =3.2 Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) =3.2 Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) =3.2 Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. Year 5 after entry into JADY
Secondary Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6 Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6 Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6 Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP =3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. Year 5 after entry into JADY
Secondary Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of =3.2 DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of =3.2 DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of =3.2 DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. Year 5 after entry into JADY
Secondary Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6 DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6 DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6 DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity. Year 5 after entry into JADY
Secondary Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm. Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm. Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm. Year 5 after entry into JADY
Secondary Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS) X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects. Baseline, Year 1
Secondary Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS) X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects. Baseline, Year 3
Secondary Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS) X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects. Baseline, Year 5
Secondary Percentage of Participants With mTSS Change =0 X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage. Year 1 after entry into JADY
Secondary Percentage of Participants With mTSS Change =0 X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage. Year 3 after entry into JADY
Secondary Percentage of Participants With mTSS Change =0 X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage. Year 5 after entry into JADY
Secondary Change From Baseline of Originating Study in Joint Space Narrowing at Year 1 X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. Baseline, Year 1
Secondary Change From Baseline of Originating Study in Joint Space Narrowing at Year 3 X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. Baseline, Year 3
Secondary Change From Baseline of Originating Study in Joint Space Narrowing at Year 5 X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing Baseline, Year 5
Secondary Change From Baseline of Originating Study in Duration of Morning Stiffness Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition. Baseline, Year 1
Secondary Change From Baseline of Originating Study in Duration of Morning Stiffness Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition. Baseline, Year 3
Secondary Change From Baseline of Originating Study in Duration of Morning Stiffness Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition. Baseline, Year 5
Secondary Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. Baseline, Year 1
Secondary Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. Baseline, Year 3
Secondary Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. Baseline, Year 5
Secondary Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. Baseline, Year 1
Secondary Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. Baseline, Year 3
Secondary Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. Baseline, Year 5
Secondary Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =10 The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =10 The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =10 The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. Years 5 after entry into JADY
Secondary Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) = 2.8 The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =2.8 The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =2.8 The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. Year 5 after entry into JADY
Secondary Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.22 The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants. Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.22 The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants. Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.22 The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants. Year 5 after entry into JADY
Secondary Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.3 The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.3 The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.3 The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Year 5 after entry into JADY
Secondary Change From Baseline of Originating Study in Bone Erosion Score The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet).
Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Baseline, Year 1
Secondary Change From Baseline of Originating Study in Bone Erosion Score The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Baseline, Year 3
Secondary Change From Baseline of Originating Study in Bone Erosion Score The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Baseline, Year 5
Secondary Healthcare Resource Utilization Number of visits to medical care providers related to treatment of Rheumatoid Arthritis (RA) outside of the clinical study. Reported here are healthcare consultations and emergency room consultations from end of originating study to end of participation in study JADY. Baseline up to 84 Months
Secondary Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =11 SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score =11.
Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =11 SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score =11.
Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =11 SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score =11.
Year 5 after entry into JADY
Secondary Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =3.3 SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of =3.3.
Year 1 after entry into JADY
Secondary Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =3.3 SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of =3.3.
Year 3 after entry into JADY
Secondary Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =3.3 SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of =3.3.
Year 5 after entry into JADY
Secondary Percentage of Participants With Relapse Event During the 96-Week Step-Down Period Relapse is defined as a Clinical Disease Activity Index score > 10. The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity.
Total number of participants at risk multiplied by estimate of cumulative event probability would need to be rounded up or down to get a whole number.
Week 0 through Week 96 of Step-down
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