Rheumatoid Arthritis Clinical Trial
— RA-BEYONDOfficial title:
A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis
| Verified date | April 2022 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
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,
| 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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