An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis (RA-BEYOND)

April 22, 2022 updated by: Eli Lilly and Company

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2877

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
        • Consultorios Asociados de Endocrinologia
      • Ciudad Autonoma de Buenos Aire, Argentina, C1428DZF
        • Consultorios Reumatológicos Pampa
      • Ciudad Autonoma de Buenos Aire, Argentina, C1440AAD
        • CENUDIAB
      • Ciudad Autonoma de Buenos Aire, Argentina, C1015ABO
        • Organizacion Medica de Investigacion - OMI
      • Ciudad Autonoma de Buenos Aire, Argentina, C1221ADC
        • Hospital Ramos Mejía
      • Ciudad Autonoma de Buenos Aire, Argentina, C1417EYG
        • Centro de Medicina Familiar Mindout Research
      • Ciudad Autonoma de Buenos Aire, Argentina, C1128AAF
        • Centro De Osteopatias - Comlit
      • Ciudad Autonoma de Buenos Aire, Argentina, C1430CKE
        • CCBR Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Argentina, C1431FWO
        • CEMIC Saavedra
      • Cordoba, Argentina, X5008HHW
        • Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico de Cordoba SA
      • Cordoba, Argentina, X5000EDC
        • Instituto Medico Strusberg
      • Cordoba, Argentina, X5004BAK
        • Hospital Italiano de Cordoba
      • San Juan, Argentina, J5402DIL
        • Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
    • Buenos Aires
      • Bahia Blanca, Buenos Aires, Argentina, B8000HXM
        • Hospital Italiano Regional del Sur
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1426AAL
        • Atencion Integral en Reumatologia
      • Mar del Plata, Buenos Aires, Argentina, B7600FYK
        • Centro de Investigaciones Médicas Mar del Plata
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Instituto de Investigaciones Clinicas Mar del Plata
      • Quilmes, Buenos Aires, Argentina, B1878DVC
        • Cer Instituto Medico
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Instituto de Investigaciones Clinicas Quilmes
      • San Isidro, Buenos Aires, Argentina, B1642
        • Instituto Medico de Alta Complejidad San Isidro
    • Ciudad Autonoma Buenos Aires
      • Caba, Ciudad Autonoma Buenos Aires, Argentina, C1125ABD
        • CENIT Centro de Neurociencias, Investigacion y Tratamiento
    • Ciudad Autonoma De Buenos Aire
      • Caba, Ciudad Autonoma De Buenos Aire, Argentina, 1204
        • Instituto Centenario
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CFJ
        • Centro de Enfermedades del Higado y Aparato Digestivo
      • Rosario, Santa Fe, Argentina, S2000
        • Instituto CAICI SRL
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000BRD
        • CIR Centro de Investigacions Reumatologicas
    • Tucumán
      • SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL
        • Centro Medico Privado de Reumatologia
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Kogarah, New South Wales, Australia, 2217
        • Combined Rheumatology Practice (CRP)
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Coast Joint Care
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
      • Fitzroy, Victoria, Australia, 3065
        • St Vincents Hospital Melbourne
  • Austria
      • Wien, Austria, 1100
        • Rheuma Zentrum Favoriten GmbH
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Universitätsklinikum Graz
  • Belgium
      • Genk, Belgium, 3600
        • Reuma Clinic, Locatie Jaarbeurslaan
      • Mons, Belgium, 7000
        • CHU Ambroise Paré
    • Brussel
      • Bruxelles, Brussel, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Universitair Ziekenhuis Gent
    • Vlaams Gewest
      • Merksem, Vlaams Gewest, Belgium, 2170
        • ZNA Jan Palfijn
  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01228-200
        • CPCLIN
      • São Paulo, SP, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigação Clínica
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 04032-060
        • Associacao de Assistencia a Crianca Deficiente (AACD)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5M 0H4
        • Rheumatology Research Associates Group
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 4N7
        • The Medical Arts Health Research Group
      • Victoria, British Columbia, Canada, V8V 3M9
        • PerCuro Clinical Research Ltd.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Manitoba Clinic Medical Corporation
    • Ontario
      • Kitchener, Ontario, Canada, N2M 5N6
        • Kw Musculoskeletal Research Inc
      • Ottawa, Ontario, Canada, K1H 1A2
        • The Ottawa Hospital
      • St. Catherines, Ontario, Canada, L2N 7E4
        • Niagara Peninsula Arthritis Centre, Inc.
      • Toronto, Ontario, Canada, M5T 3L9
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5T 2S8
        • UHN-Toronto Western Hospital
    • Quebec
      • Quebec City, Quebec, Canada, G1W 4R4
        • Center de Recherche St Louis
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Centre De Recherche Musculo-Squelettique
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Saskatoon Osteoporosis Centre
  • China
      • Beijing, China, 100029
        • China-Japan Friendship Hospital
      • Shanghai, China, 200052
        • Shanghai Guanghua Hospital
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Afflilated Hospital of Bengbu Medical College
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
      • Hefei, Anhui, China, 230022
        • The First Affiliate Hospital of AnHui Medical University
    • Beijing
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital
    • Guangzhou
      • Shantou, Guangzhou, China, 515041
        • 1st Hospital affiliated to Medical College of Shantou Univer
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital, Central South University
      • ZhuZhou, Hunan, China, 412007
        • ZhuZhou Central Hospital
    • Jiangsu
      • Yancheng, Jiangsu, China, 224005
        • Yancheng First People's Hospital
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337055
        • Pingxiang People's Hospital
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital, Fudan University
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • West China Hospital Sichuan University
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital
  • Croatia
      • Osijek, Croatia, 31000
        • KBC Osijek
      • Zagreb, Croatia, 10000
        • Klinicka bolnica Sveti Duh
      • Zagreb, Croatia, 10000
        • Poliklinika K-Centar
  • Czechia
      • Brno, Czechia, 611 41
        • Revmaclinic, s.r.o
      • Bruntal, Czechia, 792 01
        • Revmatologicka ambulance
      • Hustopece, Czechia, 693 01
        • ELIMATES BRNO s.r.o. Revmatologicka ambulance
      • Ostrava, Czechia, 702 00
        • Vesalion s.r.o.
      • Ostrava, Czechia, 722 00
        • Artroscan, s.r.o.
      • Pardubice, Czechia, 530 02
        • Arthrohelp S.R.O.
      • Uherske Hradiste, Czechia, 686 01
        • Medical Plus
      • Zlin, Czechia, 760 01
        • PV Medical Services s.r.o.
    • Praha, Hlavní Mešto
      • Praha 2, Praha, Hlavní Mešto, Czechia, 12850
        • Revmatologicky ustav
  • Denmark
    • Hovedstaden
      • Frederiksberg, Hovedstaden, Denmark, 2000
        • Frederiksberg hospital
      • Glostrup, Hovedstaden, Denmark, 2600
        • Copenhagen University Hospital
    • Syd
      • Odense C, Syd, Denmark, 5000
        • Odense Universitetshospital
  • France
      • Cahors CEDEX 9, France, 46005
        • Centre Hospitalier Jean Rougier
      • Chambray-lès-Tours, France, 37170
        • Hôpital Trousseau, CHRU de Tours
      • Montpellier Cedex 5, France, 34295
        • Hôpital Arnaud de Villeneuve - CHU Montpellier
      • Nantes Cedex 1, France, 44093
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
      • Orleans CEDEX 2, France, 45067
        • Nouvel Hôpital Orléans La Source
      • Paris CEDEX 13, France, 75651
        • Hopital de la Pitie Salpetriere
      • Paris CEDEX 14, France, 75679
        • Hôpital Cochin
      • Poitiers, France, 86021
        • CHU La Miletrie
      • Rennes CEDEX 2, France, 35056
        • CHU Rennes/Hopital Sud
      • Thionville, France, 57100
        • Hôpital Bel Air
    • Haute-Vienne
      • Limoges CEDEX, Haute-Vienne, France, 87042
        • CHRU de Limoges Hopital Dupuytren
  • Germany
      • Berlin, Germany, 10117
        • Charite Campus Virchow-Klinikum
      • Hamburg, Germany, 22081
        • Schön Klinik Hamburg Eilbek
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Universitätsklinikum Heidelberg
    • Bayern
      • Bayreuth, Bayern, Germany, 95444
        • Internistisch-rheumatologische Praxisgemeinschaft Bayreuth
      • München, Bayern, Germany, 80336
        • Klinikum der Universität München
      • Würzburg, Bayern, Germany, 97080
        • Universitätsklinikum Würzburg A. ö. R.
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Universitätsklinikum Köln
    • Sachsen
      • Dresden, Sachsen, Germany, 01067
        • Städtisches Klinikum Dresden-Friedrichstadt
    • Sachsen-Anhalt
      • Gommern, Sachsen-Anhalt, Germany, 39245
        • Immunologisches Zentrum Vogelsang-Gommern GmbH
  • Greece
      • Larissa, Greece, 41110
        • University General Hospital of Larissa
    • Attiki
      • Athens, Attiki, Greece, 11527
        • Hippokration Hospital of Athens
      • Kifissia, Attiki, Greece, 14561
        • General Hospital of Attica KAT
    • Crete
      • Heraklion, Crete, Greece, 71110
        • University General Hospital of Heraklion
  • Hungary
      • Budapest, Hungary, 1023
        • Orszagos Reumatologiai es Fizioterapias Intezet
      • Veszprem, Hungary, 8200
        • Csolnoky Ferenc Korhaz
    • Bacs-Kiskun
      • Kiskunhalas, Bacs-Kiskun, Hungary, 6400
        • Kiskunhalasi Semmelweis Korhaz
    • Bekes
      • Bekescsaba, Bekes, Hungary, 5600
        • Dr. Rethy Pal Korhaz es Rendelointezet
    • Fejer
      • Szekesfehervar, Fejer, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
    • Pest
      • Budapest, Pest, Hungary, 1027
        • Revita Clinic
    • Szabolcs-Szatmar-Bereg
      • Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
        • Szabolcs-Szatmar-Bereg M-i Korhazak es Egyetemi Oktatokorhaz
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500072
        • Sumana Hospital
    • Delhi
      • New Delhi, Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, Delhi, India, 110076
        • Indraprastha Apollo Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Shalby Hospital
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Medanta-The Medicity
    • Karnataka
      • Attavar, Mangalore, Karnataka, India, 575001
        • Manipal Centre for Clinical Research (MCCR)
      • Bangalore, Karnataka, India, 560054
        • M S Ramaiah Medical College Hospital
      • Bangalore, Karnataka, India, 560034
        • St. John Medical College & Hospital
      • Belgaum, Karnataka, India, 590010
        • KLES Prabhakar Kore Hospital and Medical Research Centre
    • Maharashtra
      • Mumbai, Maharashtra, India, 400053
        • Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
    • Rajasthan
      • Jaipur, Rajasthan, India, 302006
        • Shri Nidan Hospital & Hope Fertility Centre
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Care Hospital
    • Telengana
      • Secunderabad, Telengana, India, 500003
        • Krishna Institute of Medical Sciences Ltd.
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226018
        • CSM Medical University
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Apollo Gleneagles Hospitals Kolkata
      • Kolkata, West Bengal, India, 700020
        • IPGMER and SSKM Hospital
  • Israel
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center
      • Haifa, Israel, 3525406
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Petah Tiqva, Israel, 4941492
        • Rabin Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center
    • HaDarom
      • Ashkelon, HaDarom, Israel, 7830604
        • Barzilai Medical Center
    • Ḥeifā
      • Haifa, Ḥeifā, Israel, 3436212
        • Carmel Hospital
  • Italy
      • Firenze, Italy, 50139
        • Azienda Ospedaliera Universitaria Careggi
      • Milano, Italy, 20157
        • Ospedale Luigi Sacco
      • Pisa, Italy, 56100
        • Stabilimento Ospedaliero Santa Chiara
      • Roma, Italy, 00161
        • Polic.Umberto I -Univ. La Sapienza
      • Torino, Italy, 10154
        • Ospedale San Giovanni Bosco
      • Verona, Italy, 37134
        • Ospedale Policlinico Giambattista Rossi, Borgo Roma
  • Japan
      • Fukuoka, Japan, 814-0002
        • SHONO Rheumatism Clinic
      • Fukuoka, Japan, 810-0001
        • Kondo clinic for rheumatism and orthopaedics
      • Fukuoka, Japan, 810 8563
        • National Hospital Organization Kyushu Medical Center
      • Fukuoka, Japan, 813-0017
        • Medical Co. LTA Fukuoka Mirai Hospital
      • Hiroshima, Japan, 733-0032
        • Hiroshima Clinic
      • Hiroshima, Japan, 730-0017
        • Hiroshima Rheumatology Clinic
      • Kagoshima, Japan, 891-0133
        • Kagoshima red cross hospital
      • Kumamoto, Japan, 862-8655
        • Kumamoto Shinto General Hospital
      • Kumamoto, Japan, 861-5515
        • Kumamoto Rheumatology Clinic
      • Kumamoto, Japan, 862-0976
        • Kumamoto Orthopedic Hospital
      • Nagano, Japan, 380-8582
        • Nagano Red Cross Hospital
      • Nagasaki, Japan, 852-8511
        • The Japanese Red Cross Nagasaki Genbaku Hospital
      • Nagasaki, Japan, 850-0832
        • Nagasaki Medical Hospital of Rheumatology
      • Oita, Japan, 870-0823
        • Oribe Clinic Rheumatism and Medicine
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Okayama, Japan, 700-0013
        • Okayama Saiseikai General Hospital Outpatient Center
      • Okayama, Japan, 700-8607
        • Japanese Red Cross Okayama Hospital
      • Osaka, Japan, 545-0011
        • Yokota Clinic for Rheumatology
      • Shizuoka, Japan, 420-0821
        • Shizuoka Rheumatism orthopedic Rehabilitation Hospital
      • Shizuoka, Japan, 420-8623
        • JA-Shizuoka Shizuoka-Kosei General Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Nagoya University Hospital
      • Nagoya, Aichi, Japan, 455-8530
        • Chubu-Rosai Hospital
      • Nagoya, Aichi, Japan, 460-0001
        • Nagoya Medical Center
    • Chiba
      • Chuo-ku, Chiba, Japan, 260-8712
        • National Chiba-East-Hospital
      • Matsudo, Chiba, Japan, 271-8511
        • Matsudo City Hospital
      • Narashino, Chiba, Japan, 275-8580
        • Chibaken Saiseikai Narashino Hospital
      • Yotsukaido, Chiba, Japan, 284-0003
        • Shimoshizu National Hospital
    • Fukuoka
      • Hakata-ku, Fukuoka, Japan, 812-0025
        • PS Clinic
      • Iizuka, Fukuoka, Japan, 820-8505
        • Aso Iizuka Hospital
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • University of Occupational and Enviromental Health
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8644
        • National Hospital Organization Asahikawa Medical Center
      • Asahikawa, Hokkaido, Japan, 078-8243
        • Katayama Clinic
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
      • Sapporo, Hokkaido, Japan, 060-0001
        • Sagawa Akira Rheumatology Clinic
      • Sapporo, Hokkaido, Japan, 060-0061
        • NTT East Japan Sapporo Hospital
      • Sapporo, Hokkaido, Japan, 063-0811
        • Hokkaido Medical Center for Rheumatic Diseases
    • Hyogo
      • Kato, Hyogo, Japan, 673-1462
        • Matsubara Mayflower Hospital
      • Takarazuka, Hyogo, Japan, 665-0827
        • Takarazuka City Hospital
    • Ibaragi
      • Hitachi, Ibaragi, Japan, 316-0015
        • OASIS Clinic
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • Tsukuba University Hospital
    • Iwate
      • Morioka, Iwate, Japan, 020-0015
        • Yoshida Orthopaedic and Rheumatic Clinic
      • Morioka, Iwate, Japan, 020-0034
        • Komagamine Orthopedic and Rheumatology Clinic
    • Kagawa
      • Kita-gun, Kagawa, Japan, 761-0793
        • Kagawa University Hospital
    • Kagoshima
      • Kirishima, Kagoshima, Japan, 899-5117
        • Yoshitama Clinic Rheumatology & Internal Medicine
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St Marianna University School of Medicine Hospital
      • Yokohama, Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital
      • Yokohama, Kanagawa, Japan, 236-0037
        • Yokohama Minami Kyosai Hospital
      • Yokohama, Kanagawa, Japan, 222-0036
        • Yokohama Rosai Hospital
      • Yokohama-City, Kanagawa, Japan, 224-0041
        • Tsuzuki Azuma Clinic: Primary care and Rheumatology
    • Kumamoto
      • Koshi, Kumamoto, Japan, 861-1196
        • Kumamoto Saishun Medical Center
    • Mie
      • Yokkaichi, Mie, Japan, 510-0016
        • Yokkaichi Hazu Medical Center
    • Nagasaki
      • Omura, Nagasaki, Japan, 856-8562
        • National Nagasaki Medical Center
      • Sasebo, Nagasaki, Japan, 857-1195
        • Sasebo Chuo Hospital
    • Niigata
      • Nagaoka, Niigata, Japan, 940-2085
        • Nagaoka Red Cross Hospital
      • Shibata, Niigata, Japan, 957-0054
        • Niigata Rheumatic Center
    • Okayama
      • Setouchi, Okayama, Japan, 701-4264
        • Osafune Clinic
    • Okinawa
      • Tomigusuku, Okinawa, Japan, 901-0243
        • Tomishiro Central Hospital
    • Saga
      • Ureshino, Saga, Japan, 843 0301
        • NHO Ureshino Medical Center
    • Saitama
      • Kawagoe, Saitama, Japan, 350-8550
        • Saitama Medical Center
      • Kawaguchi, Saitama, Japan, 333-0833
        • Kaneko Clinic
      • Sayama, Saitama, Japan, 350-1305
        • Azuma Rheumatology Clinic
      • Tokorozawa, Saitama, Japan, 359-1111
        • Hirose Clinic
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 430-8558
        • Seirei Hamamatsu General Hospital
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Arakawa-ku, Tokyo, Japan, 116-8567
        • Tokyo Women's Medical University East Medical Center
      • Chuo-Ku, Tokyo, Japan, 104 8560
        • St. Lukes International Hospital
      • Hachioji, Tokyo, Japan, 193-0931
        • Fujimori Clinic
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital
      • Meguro-Ku, Tokyo, Japan, 152-8902
        • National Tokyo Medical Center
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University Hospital
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
    • Toyama
      • Takaoka, Toyama, Japan, 933-0874
        • Takaoka Rheumatic Orthopedic CL
    • Yamaguchi
      • Shunan, Yamaguchi, Japan, 745-0824
        • Miyasato Clinic
  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital
    • Korea
      • Dae Jeon, Korea, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Daegu, Korea, Korea, Republic of, 41944
        • Kyung Pook National University Hospital
      • Daegu, Korea, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center
      • Daejeon, Korea, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Gwangju, Korea, Korea, Republic of, 61469
        • Chonnam National University Hospital
      • Incheon, Korea, Korea, Republic of, 22332
        • Inha University Hospital
      • Incheon, Korea, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Seoul, Korea, Korea, Republic of, 06591
        • Seoul St. Mary's hospital
      • Seoul, Korea, Korea, Republic of, 04763
        • Hanyang University Medical Center
      • Seoul, Korea, Korea, Republic of, 02447
        • Kyung Hee University Hospital
      • Seoul, Korea, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Korea, Republic of, 05278
        • Kyunghee University Hospital at Gangdong
      • Seoul, Korea, Korea, Republic of, 07061
        • Seoul Municipal Boramae Hospital
      • Seoul, Korea, Korea, Republic of, 07345
        • Catholic University of Korea Yeouido St. Mary's Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05030
        • Konkuk University Medical Center
  • Latvia
      • Liepaja, Latvia, LV-3401
        • Rheumatology Practice in Jaunliepaja Primary Health Care Cen
      • Riga, Latvia, LV-1002
        • Pauls Stradins Kliniska Universitates Slimnica
      • Valmiera, Latvia, LV-4201
        • Dr. Sarmite Saleniece
  • Lithuania
      • Kaunas, Lithuania, LT-50128
        • Dr. Kildos Klinika
      • Klaipeda, Lithuania, LT-92288
        • Klaipedos Universitetine Ligonine
      • Siauliai, Lithuania, LT-76231
        • Respublikine Siauliu Ligonine
  • Mexico
      • San Luis Potosi, Mexico, 78213
        • Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
    • Baja California
      • Mexicali, Baja California, Mexico, 21200
        • Ctro Inv en Artritis y Osteoporosis SC
      • Tijuana, Baja California, Mexico, 22010
        • Centro de Investigación del Noroeste
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 03100
        • RM Pharma Specialists S.A. de C.V.
      • Mexico City, Distrito Federal, Mexico, 06090
        • Hospital de Jesus I.A.P.
      • Mexico City, Distrito Federal, Mexico, 03100
        • Mexico Centre for Clinical Research SA de CV
      • Mexico City, Distrito Federal, Mexico, 06100
        • Comite Mexicano para la Prevencion de la Osteoporosis A.C.
      • Mexico City, Distrito Federal, Mexico, 06700
        • Mentrials S.A. de C.V
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Centro Integral en Reumatologia SA de CV
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S. C.
      • Guadalajara, Jalisco, Mexico, 44690
        • Centro de Estudios de Investigacion Basica y Clinica, S.C.
      • Guadalajara, Jalisco, Mexico, 44620
        • Unidad de Investigacion en Enfermedades Cronico Degenerative
      • Guadalajara, Jalisco, Mexico, 44650
        • Private Service
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64020
        • Hospital Universitario de Monterrey
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Centro Medico de las Américas
      • Merida, Yucatan, Mexico, 97070
        • Medical Care and Research, S.A. de C.V.
  • Netherlands
      • Almelo, Netherlands, 7600 SZ
        • Ziekenhuisgroep Twente, Almelo
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
      • Elblag, Poland, 82-300
        • Ambulatorium Barbara Bazela
      • Katowice, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
      • Lodz, Poland, 90242
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
      • Nadarzyn, Poland, 05-830
        • NZOZ Lecznica MAK-MED s.c.
      • Warszawa, Poland, 03-291
        • Centrum Medyczne AMED
      • Warszawa, Poland, 02-691
        • Reumatika - Centrum Reumatologii
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badań Klinicznych PI-House Sp. z o.o.
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia da Orta
      • Lisbon, Portugal, 1050-034
        • Instituto Portugues de Reumatologia
      • Ponte de Lima, Portugal, 4990-041
        • Hospital do Conde de Bertiandos
      • Porto, Portugal, 4099-001
        • Hospital Geral de Santo Antonio
      • Porto, Portugal, 4200-319
        • Hospital de Sao Joao E.P.E.
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Ramon L. Ortega Colon
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine CAIMED Center
      • San Juan, Puerto Rico, 00918
        • Mindful Medical Research
      • San Juan, Puerto Rico, 00909
        • Latin Clinical Trial Center
      • San Juan, Puerto Rico, 00927
        • Barbara Diaz Hernandez
  • Romania
      • Bucuresti, Romania, 011172
        • Spitalul Clinic Sf Maria Bucuresti
      • Bucuresti, Romania, 020475
        • Spitalul Clinic "Dr. Ioan Cantacuzino"
      • Bucuresti, Romania, 010584
        • SC DUO Medical S.R.L Rheumatology
      • Constanta, Romania, 900591
        • Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
      • Iasi, Romania, 700661
        • Spitalul Clinic de Recuperare Iasi
    • Mures
      • Tg.Mures, Mures, Romania, 540136
        • Spital Clinic Judetean de Urgenta Tg.Mures
  • Russian Federation
      • Korolev, Russian Federation, 141060
        • Family Clinic No 4
      • Moscow, Russian Federation, 115522
        • V.A. Nasonova Research Institute of Rheumatology
      • Moscow, Russian Federation, 119049
        • City Clinical Hospital 1 named after N.I. Pirogov
      • Moscow, Russian Federation, 119992
        • First Moscow State Medical University
      • Ryazan, Russian Federation, 390026
        • Ryazan Regional Clinincal Cardiology Dispensary
      • Saratov, Russian Federation, 410053
        • Saratov regional clinical hospital
      • St. Petersburg, Russian Federation, 190068
        • Clinical Rheumatology Hospital # 25
      • Yaroslavl, Russian Federation, 150003
        • Clinical Emergency Hospital N.V.Solovyov
    • Leningradskaya Oblast'
      • Saint-Petersburg, Leningradskaya Oblast', Russian Federation, 194291
        • Gbuz Lokb
    • Ul'yanovskaya Oblast
      • Ul'yanovsk, Ul'yanovskaya Oblast, Russian Federation, 432063
        • GUZ UOKB
  • Slovakia
      • Bratislava, Slovakia, 85101
        • ROMJAN s.r.o.
      • Bratislava, Slovakia, 84231
        • Neštátna Reumatologická Ambulancia
      • Partizanske, Slovakia, 958 01
        • Reumacentrum s.r.o.
      • Spisska Nova Ves, Slovakia, 05201
        • REUMED s.r.o.
      • Topolcany, Slovakia, 955 01
        • LERAM s.r.o.
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Bolnisnica Dr. P. Drzaja UKCLJ
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Netcare Greenacres Hospital
    • KZ-Natal
      • Durban, KZ-Natal, South Africa, 4092
        • Precise Clinical Solutions (Pty) Ltd
      • Durban, KZ-Natal, South Africa, 4001
        • Saint Augustine's Hospital
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Arthritis Clinical Trial Centre
      • Somerset West, Western Cape, South Africa, 7130
        • Somerset West Trial Centre
      • Stellenbosch, Western Cape, South Africa, 7600
        • Winelands Medical Research Centre
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Sevilla, Spain, 41071
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe de Valencia
    • Alicante
      • La Vila Joiosa, Alicante, Spain, 03570
        • Hospital Marina Baixa
    • Andalucía
      • Sevilla, Andalucía, Spain, 41010
        • Hospital Quiron Infanta Luisa
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacion Sanitaria Parc Tauli
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Hospital Universitario Getafe
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital De Basurto
  • Sweden
      • Malmo, Sweden, 20502
        • Reumatologiska Kliniken Skånes universitetssjukhus Malmö
    • Gothenburg
      • Göteborg, Gothenburg, Sweden, 41345
        • Sahlgrenska Universitetssjukhuset
  • Switzerland
      • Fribourg, Switzerland, 1708
        • HFR Fribourg - Hôpital Cantonal
      • Zürich, Switzerland, 8091
        • Universitatsspital Zurich
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • CHUV Centre Hospitalier Universitaire Vaudois
  • Taiwan
      • Kaohsiung City, Taiwan, 833401
        • Chang Gung Memorial Hospital - Kaohsiung Branch
      • Neihu Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taichung City, Taiwan, 40447
        • China Medical University Hospital
      • Taichung City, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Taipei City, Taiwan, 10048
        • National Taiwan University Hospital
      • Taipei City, Taiwan, 104217
        • Mackay Memorial Hospital
      • Taipei City, Taiwan, 106438
        • Cathay General Hospital
      • Taipei City, Taiwan, 112201
        • Taipei Veterans General Hospital
      • Yongkang City, Taiwan, 71004
        • Chi-Mei Medical Center
  • Turkey
      • Edirne, Turkey, 22030
        • Trakya University
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire Hospital
    • Hants
      • Southampton, Hants, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • Surrey
      • London, Surrey, United Kingdom, E11 1NR
        • Whipps Cross University Hospital
      • London, Surrey, United Kingdom, SE1 9RT
        • Guy's Hospital
    • Tyneside
      • Newcastle upon Tyne, Tyneside, United Kingdom, NE29 8NH
        • Northumbria Healthcare NHS Foundation Trust
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD5 0NA
        • St Lukes Hospital
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Mesa, Arizona, United States, 85202
        • Arizona Arthritis & Rheumatology Associates, P. C.
      • Peoria, Arizona, United States, 85381
        • Sun Valley Arthritis Center, LTD
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Fresno, California, United States, 93720
        • Valley Endocrine, Fresno
      • La Jolla, California, United States, 92037
        • Allergy and Rheumatology Medical Clinic Inc
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
      • Palo Alto, California, United States, 94304
        • Stanford University Hospital
      • Santa Maria, California, United States, 93454
        • Pacific Arthritis Center
      • Upland, California, United States, 91786
        • Inland Rheumatology & Osteoporosis Medical Group
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Boulder Medical Center
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic - Lowry
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • New England Research Associates
      • Danbury, Connecticut, United States, 06810
        • Clinical Research Center of CT/NY
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Delaware Arthritis
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Orthopedic Research Institute
      • Naples, Florida, United States, 34102
        • Medallion Clinical Research Institute
      • New Port Richey, Florida, United States, 34652
        • Sun Coast Clinical Research, Inc
      • Orlando, Florida, United States, 32806
        • Rheumatology Associates of Central Florida
      • Orlando, Florida, United States, 32804
        • Omega Research Consultants
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Research of Florida
      • Tamarac, Florida, United States, 33321
        • West Broward Rheumatology Associates, Inc
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group, P.A.
      • Tampa, Florida, United States, 33613
        • AdventHealth Medical Group
    • Idaho
      • Boise, Idaho, United States, 83702
        • Intermountain Research Center
    • Illinois
      • Vernon Hills, Illinois, United States, 60061
        • Deerbrook Medical Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
      • Indianapolis, Indiana, United States, 46227
        • Diagnostic Rheumatology and Research
      • Indianapolis, Indiana, United States, 46260
        • Goldpoint Clinical Research LLC
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Klein and Associates MD, PA
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • West Michigan Rheumatology
      • Kalamazoo, Michigan, United States, 49009
        • Borgess Rheumatology
      • Lansing, Michigan, United States, 48910
        • Advanced Rheumatology, PC
      • Lansing, Michigan, United States, 48910
        • Office: Dr. Fiechtner, Justus
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Arthritis and Osteporosis Treatment and Research Center
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
      • Saint Louis, Missouri, United States, 63141
        • Arthritis Consultants, Inc.
      • Saint Louis, Missouri, United States, 63117
        • Clayton Medical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Dr. George Timothy Kelly
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • (AOA) Arthritis & Osteoporosis Associates
      • Toms River, New Jersey, United States, 08755
        • Ocean Rheumatology, PA
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc.
    • New York
      • Albany, New York, United States, 12203
        • The Center for Rheumatology
      • Hartsdale, New York, United States, 10530
        • Drug Trials of America
      • Rochester, New York, United States, 14618
        • Allergy Asthma Immunology of Rochester, AAIR Research Ctr
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Rheumatology & Osteoporosis Research Assoc, PA
      • Charlotte, North Carolina, United States, 28207
        • Arthritis and Osteoporosis Consultants of the Carolinas
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultant
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • East Penn Rheumatology Associates
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Philadelphia, Pennsylvania, United States, 19152
        • Arthritis Group
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Center of Reading,LLC
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Rheumatology and Neurology Associates
    • Texas
      • Cypress, Texas, United States, 77429
        • Pioneer Research Solutions
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research Center
      • League City, Texas, United States, 77573
        • Accurate Clinical Research
      • Lubbock, Texas, United States, 79424
        • Arthritis & Osteoporosis Associates LLP
      • Webster, Texas, United States, 77598
        • Accurate Clinical Research
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Center for Arthritis and Rheumatic Diseases, PC
    • Washington
      • Bothell, Washington, United States, 98021
        • Western Washington Arthritis Clinic
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Rheumatology
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Rheumatology and Immunotherapy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 4 milligram (mg) Baricitinib

4 mg Baricitinib administered orally once daily.

Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Drug: Placebo
Administered orally
Drug: Baricitinib
Administered orally
Other Names:
  • INCB 028050
  • LY 3009104
EXPERIMENTAL: 2 mg Baricitinib

2 mg Baricitinib administered orally once daily.

Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Drug: Placebo
Administered orally
Drug: Baricitinib
Administered orally
Other Names:
  • INCB 028050
  • LY 3009104
EXPERIMENTAL: 2 mg Baricitinib Step-down

2 mg Baricitinib administered orally once daily in the 96-week Step-down period.

Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Drug: Baricitinib
Administered orally
Other Names:
  • INCB 028050
  • LY 3009104
EXPERIMENTAL: 4 mg Baricitinib Step-down

4 mg Baricitinib administered orally once daily in the 96-week Step-down period.

Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Drug: Baricitinib
Administered orally
Other Names:
  • INCB 028050
  • LY 3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
Time Frame: Baseline through 84 Months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Time Frame: Year 5 after entry into JADY
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
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Time Frame: Year 5 after entry into JADY
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
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Time Frame: Year 5 after entry into JADY
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
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Time Frame: Year 5 after entry into JADY
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
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Time Frame: Year 5 after entry into JADY
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
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Time Frame: Year 5 after entry into JADY
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
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Time Frame: Year 5 after entry into JADY
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
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Time Frame: Year 5 after entry into JADY
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
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Time Frame: Baseline, Year 1
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
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Time Frame: Baseline, Year 3
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
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Time Frame: Baseline, Year 5
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
Percentage of Participants With mTSS Change ≤0
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants With mTSS Change ≤0
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants With mTSS Change ≤0
Time Frame: Year 5 after entry into JADY
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
Change From Baseline of Originating Study in Joint Space Narrowing at Year 1
Time Frame: Baseline, 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
Change From Baseline of Originating Study in Joint Space Narrowing at Year 3
Time Frame: Baseline, 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
Change From Baseline of Originating Study in Joint Space Narrowing at Year 5
Time Frame: Baseline, 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
Change From Baseline of Originating Study in Duration of Morning Stiffness
Time Frame: Baseline, Year 1
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
Change From Baseline of Originating Study in Duration of Morning Stiffness
Time Frame: Baseline, Year 3
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
Change From Baseline of Originating Study in Duration of Morning Stiffness
Time Frame: Baseline, Year 5
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
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Time Frame: Baseline, Year 1
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
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Time Frame: Baseline, Year 3
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
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Time Frame: Baseline, Year 5
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
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Time Frame: Baseline, Year 1
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
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Time Frame: Baseline, Year 3
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
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Time Frame: Baseline, Year 5
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
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Time Frame: Years 5 after entry into JADY
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
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤ 2.8
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
Time Frame: Year 5 after entry into JADY
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
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Time Frame: Year 1 after entry into JADY
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
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Time Frame: Year 3 after entry into JADY
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
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Time Frame: Year 5 after entry into JADY
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
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Time Frame: Year 1 after entry into JADY

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
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Time Frame: Year 3 after entry into JADY

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
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Time Frame: Year 5 after entry into JADY

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
Change From Baseline of Originating Study in Bone Erosion Score
Time Frame: Baseline, Year 1

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
Change From Baseline of Originating Study in Bone Erosion Score
Time Frame: Baseline, Year 3

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
Change From Baseline of Originating Study in Bone Erosion Score
Time Frame: Baseline, Year 5

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
Healthcare Resource Utilization
Time Frame: Baseline up to 84 Months
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
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Time Frame: Year 1 after entry into JADY

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
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Time Frame: Year 3 after entry into JADY

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
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Time Frame: Year 5 after entry into JADY

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
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
Time Frame: Year 1 after entry into JADY

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
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
Time Frame: Year 3 after entry into JADY

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
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
Time Frame: Year 5 after entry into JADY

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
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period
Time Frame: Week 0 through Week 96 of Step-down

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 27, 2013

Primary Completion (ACTUAL)

November 12, 2020

Study Completion (ACTUAL)

November 12, 2020

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (ESTIMATE)

June 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14060
  • I4V-MC-JADY (OTHER: Eli Lilly and Company)
  • 2012-003686-17 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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