An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
NCT ID: NCT01885078
Last Updated: 2022-04-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
2877 participants
INTERVENTIONAL
2013-06-27
2020-11-12
Brief Summary
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The study provides 7 years of additional treatment with baricitinib.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Baricitinib
Administered orally
Placebo
Administered orally
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.
Baricitinib
Administered orally
Placebo
Administered orally
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.
Baricitinib
Administered orally
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.
Baricitinib
Administered orally
Interventions
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Baricitinib
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, United States
Sun Valley Arthritis Center, LTD
Peoria, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Valley Endocrine, Fresno
Fresno, California, United States
Allergy and Rheumatology Medical Clinic Inc
La Jolla, California, United States
Desert Medical Advances
Palm Desert, California, United States
Stanford University Hospital
Palo Alto, California, United States
Pacific Arthritis Center
Santa Maria, California, United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, United States
Boulder Medical Center
Boulder, Colorado, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States
New England Research Associates
Bridgeport, Connecticut, United States
Clinical Research Center of CT/NY
Danbury, Connecticut, United States
Delaware Arthritis
Lewes, Delaware, United States
Orthopedic Research Institute
Boynton Beach, Florida, United States
Medallion Clinical Research Institute
Naples, Florida, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States
Omega Research Consultants
Orlando, Florida, United States
Rheumatology Associates of Central Florida
Orlando, Florida, United States
Arthritis Research of Florida
Palm Harbor, Florida, United States
West Broward Rheumatology Associates, Inc
Tamarac, Florida, United States
AdventHealth Medical Group
Tampa, Florida, United States
Tampa Medical Group, P.A.
Tampa, Florida, United States
Intermountain Research Center
Boise, Idaho, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
Diagnostic Rheumatology and Research
Indianapolis, Indiana, United States
Goldpoint Clinical Research LLC
Indianapolis, Indiana, United States
Klein and Associates MD, PA
Cumberland, Maryland, United States
West Michigan Rheumatology
Grand Rapids, Michigan, United States
Borgess Rheumatology
Kalamazoo, Michigan, United States
Advanced Rheumatology, PC
Lansing, Michigan, United States
Office: Dr. Fiechtner, Justus
Lansing, Michigan, United States
Arthritis and Osteporosis Treatment and Research Center
Flowood, Mississippi, United States
University of Missouri
Columbia, Missouri, United States
Clayton Medical Research
St Louis, Missouri, United States
Arthritis Consultants, Inc.
St Louis, Missouri, United States
Dr. George Timothy Kelly
Las Vegas, Nevada, United States
(AOA) Arthritis & Osteoporosis Associates
Freehold, New Jersey, United States
Ocean Rheumatology, PA
Toms River, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
The Center for Rheumatology
Albany, New York, United States
Drug Trials of America
Hartsdale, New York, United States
Allergy Asthma Immunology of Rochester, AAIR Research Ctr
Rochester, New York, United States
Asheville Rheumatology & Osteoporosis Research Assoc, PA
Asheville, North Carolina, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States
Paramount Medical Research
Middleburg Heights, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Healthcare Research Consultant
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Arthritis Group
Philadelphia, Pennsylvania, United States
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, United States
Carolina Rheumatology and Neurology Associates
Myrtle Beach, South Carolina, United States
Pioneer Research Solutions
Cypress, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Accurate Clinical Research
League City, Texas, United States
Arthritis & Osteoporosis Associates LLP
Lubbock, Texas, United States
Accurate Clinical Research
Webster, Texas, United States
Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, United States
Western Washington Arthritis Clinic
Bothell, Washington, United States
Kadlec Clinic Rheumatology
Kennewick, Washington, United States
The Vancouver Clinic
Vancouver, Washington, United States
Rheumatology and Immunotherapy Center
Franklin, Wisconsin, United States
Hospital Italiano Regional del Sur
Bahía Blanca, Buenos Aires, Argentina
Atencion Integral en Reumatología
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
CER Instituto Medico
Quilmes, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, Argentina
Instituto Medico de Alta Complejidad San Isidro
San Isidro, Buenos Aires, Argentina
CENIT Centro de Neurociencias, Investigación y Tratamiento
CABA, Ciudad Autonoma Buenos Aires, Argentina
Instituto Centenario
CABA, Ciudad Autonoma de Buenos Aire, Argentina
Centro de Enfermedades del Higado y Aparato Digestivo
Rosario, Santa Fe Province, Argentina
Instituto CAICI SRL
Rosario, Santa Fe Province, Argentina
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, Tucumán Province, Argentina
CIR Centro de Investigacions Reumatologicas
San Miguel de Tucumán, Tucumán Province, Argentina
Consultorios Asociados de Endocrinologia
Ciudad Autonoma Buenos Aires, , Argentina
Organizacion Medica de Investigacion - OMI
Ciudad Autonoma de Buenos Aire, , Argentina
Centro De Osteopatias - Comlit
Ciudad Autonoma de Buenos Aire, , Argentina
Hospital Ramos Mejia
Ciudad Autonoma de Buenos Aire, , Argentina
Centro de Medicina Familiar Mindout Research
Ciudad Autonoma de Buenos Aire, , Argentina
Consultorios Reumatologicos Pampa
Ciudad Autonoma de Buenos Aire, , Argentina
CCBR Buenos Aires
Ciudad Autonoma de Buenos Aire, , Argentina
CEMIC Saavedra
Ciudad Autonoma de Buenos Aire, , Argentina
CENUDIAB
Ciudad Autonoma de Buenos Aire, , Argentina
Instituto Medico Strusberg
Córdoba, , Argentina
Hospital Italiano de Cordoba
Córdoba, , Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, , Argentina
Hospital Privado Centro Medico de Cordoba SA
Córdoba, , Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
San Juan, , Argentina
Canberra Hospital
Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Combined Rheumatology Practice (CRP)
Kogarah, New South Wales, Australia
Coast Joint Care
Maroochydore, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Universitätsklinikum Graz
Graz, Styria, Austria
Rheuma Zentrum Favoriten GmbH
Vienna, , Austria
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
ZNA Jan Palfijn
Merksem, Flanders, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium
Reuma Clinic, Locatie Jaarbeurslaan
Genk, , Belgium
CHU Ambroise Pare
Mons, , Belgium
CPCLIN
São Paulo, São Paulo, Brazil
Associacao de Assistencia a Crianca Deficiente (AACD)
São Paulo, São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, São Paulo, Brazil
Rheumatology Research Associates Group
Edmonton, Alberta, Canada
The Medical Arts Health Research Group
Kelowna, British Columbia, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, Canada
Manitoba Clinic Medical Corporation
Winnipeg, Manitoba, Canada
KW Musculoskeletal Research Inc
Kitchener, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Niagara Peninsula Arthritis Centre, Inc.
Saint Catherines, Ontario, Canada
UHN-Toronto Western Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Center de Recherche St Louis
Québec, Quebec, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, Canada
Saskatoon Osteoporosis Centre
Saskatoon, Saskatchewan, Canada
Afflilated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliate Hospital of AnHui Medical University
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
1st Hospital affiliated to Medical College of Shantou Univer
Shantou, Guangzhou, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
ZhuZhou Central Hospital
Zhuzhou, Hunan, China
YanCheng First People's Hospital
Yancheng, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Ningbo First Hospital
Ningbo, Zhejiang, China
China-Japan Friendship Hospital
Beijing, , China
Shanghai Guanghua Hospital
Shanghai, , China
KBC Osijek
Osijek, , Croatia
Klinicka bolnica Sveti Duh
Zagreb, , Croatia
Poliklinika K-centar
Zagreb, , Croatia
Revmatologicky ustav
Prague, Praha, Hlavní Mešto, Czechia
Revmaclinic, s.r.o
Brno, , Czechia
Revmatologicka ambulance
Bruntál, , Czechia
ELIMATES BRNO s.r.o. Revmatologicka ambulance
Hustopeče, , Czechia
Vesalion s.r.o.
Ostrava, , Czechia
Artroscan, s.r.o.
Ostrava, , Czechia
ARTHROHELP s.r.o.
Pardubice, , Czechia
Medical Plus
Uherské Hradiště, , Czechia
PV Medical Services s.r.o.
Zlín, , Czechia
Frederiksberg Hospital
Frederiksberg, Capital Region, Denmark
Copenhagen University Hospital
Glostrup Municipality, Capital Region, Denmark
Odense Universitetshospital
Odense C, Syd, Denmark
CHRU de Limoges Hopital Dupuytren
Limoges, Haute-Vienne, France
Centre Hospitalier Jean Rougier
Cahors, , France
Hôpital Trousseau, CHRU de Tours
Chambray-lès-Tours, , France
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, , France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, , France
Nouvel Hôpital Orléans La Source
Orléans, , France
Hopital de la Pitie Salpetriere
Paris, , France
Hopital Cochin
Paris, , France
CHU la Miletrie
Poitiers, , France
CHU Rennes/Hopital Sud
Rennes, , France
Hopital Bel Air
Thionville, , France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Internistisch-rheumatologische Praxisgemeinschaft Bayreuth
Bayreuth, Bavaria, Germany
Klinikum der Universität München
München, Bavaria, Germany
Universitätsklinikum Würzburg A. ö. R.
Würzburg, Bavaria, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Saxony, Germany
Immunologisches Zentrum Vogelsang-Gommern GmbH
Gommern, Saxony-Anhalt, Germany
Charité Campus Virchow-Klinikum
Berlin, , Germany
Schön Klinik Hamburg Eilbek
Hamburg, , Germany
Hippokration Hospital of Athens
Athens, Attica, Greece
General Hospital of Attica KAT
Kifissia, Attica, Greece
University General Hospital of Heraklion
Heraklion, Crete, Greece
University General Hospital of Larissa
Larissa, , Greece
Dr. Rethy Pal Korhaz es Rendelointezet
Békéscsaba, Bekes County, Hungary
Kiskunhalasi Semmelweis Korhaz
Kiskunhalas, Bács-Kiskun county, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Fejér, Hungary
Revita Clinic
Budapest, Pest County, Hungary
Szabolcs-Szatmar-Bereg M-i Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Orszagos Reumatologiai es Fizioterapias Intezet
Budapest, , Hungary
Csolnoky Ferenc Korhaz
Veszprém, , Hungary
Sumana Hospital
Hyderabad, Andhra Pradesh, India
Shalby Hospital
Ahmedabad, Gujarat, India
Medanta-The Medicity
Gurgaon, Haryana, India
Manipal Centre for Clinical Research (MCCR)
Attavar, Mangalore, Karnataka, India
St. John Medical College & Hospital
Bangalore, Karnataka, India
M S Ramaiah Medical College Hospital
Bangalore, Karnataka, India
KLES Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, India
Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
Mumbai, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Indraprastha Apollo Hospital
New Delhi, National Capital Territory of Delhi, India
Shri Nidan Hospital & Hope Fertility Centre
Jaipur, Rajasthan, India
Care Hospital
Hyderabad, Telangana, India
Krishna Institute of Medical Sciences Ltd.
Secunderabad, Telangana, India
CSM Medical University
Lucknow, Uttar Pradesh, India
IPGMER and SSKM Hospital
Kolkata, West Bengal, India
Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, India
Barzilai Medical Center
Ashkelon, Southern District, Israel
Bnai Zion Medical Center
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Carmel Hospital
Haifa, Ḥeifā, Israel
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Ospedale Luigi Sacco
Milan, , Italy
Stabilimento Ospedaliero Santa Chiara
Pisa, , Italy
Polic.Umberto I -Univ. La Sapienza
Roma, , Italy
Ospedale San Giovanni Bosco
Torino, , Italy
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Verona, , Italy
Chubu-Rosai Hospital
Nagoya, Aichi-ken, Japan
Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
National Chiba-East-Hospital
Chuo-ku, Chiba, Japan
Matsudo City Hospital
Matsudo, Chiba, Japan
Chibaken Saiseikai Narashino Hospital
Narashino, Chiba, Japan
Shimoshizu National Hospital
Yotsukaidō, Chiba, Japan
PS Clinic
Hakata-ku, Fukuoka, Japan
Aso Iizuka Hospital
Iizuka, Fukuoka, Japan
University of Occupational and Enviromental Health
Kitakyushu, Fukuoka, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, Japan
Katayama Clinic
Asahikawa, Hokkaido, Japan
Sagawa Akira Rheumatology Clinic
Sapporo, Hokkaido, Japan
NTT East Japan Sapporo Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Hokkaido Medical Center for Rheumatic Diseases
Sapporo, Hokkaido, Japan
Matsubara Mayflower Hospital
Katō, Hyōgo, Japan
Takarazuka City Hospital
Takarazuka, Hyōgo, Japan
Oasis Clinic
Hitachi, Ibaragi, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan
Yoshida Orthopaedic and Rheumatic Clinic
Morioka, Iwate, Japan
Komagamine Orthopedic and Rheumatology Clinic
Morioka, Iwate, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Yoshitama Clinic Rheumatology & Internal Medicine
Kirishima, Kagoshima-ken, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
St Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Yokohama Rosai Hospital
Yokohama, Kanagawa, Japan
Tsuzuki Azuma Clinic: Primary care and Rheumatology
Yokohama, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Yokohama Minami Kyosai Hospital
Yokohama, Kanagawa, Japan
Kumamoto Saishun Medical Center
Kōshi, Kumamoto, Japan
Yokkaichi Hazu Medical Center
Yokkaichi, Mie-ken, Japan
National Nagasaki Medical Center
Ōmura, Nagasaki, Japan
Sasebo Chuo Hospital
Sasebo, Nagasaki, Japan
Nagaoka Red Cross Hospital
Nagaoka, Niigata, Japan
Niigata Rheumatic Center
Shibata, Niigata, Japan
Osafune Clinic
Setouchi, Okayama-ken, Japan
Tomishiro Central Hospital
Tomigusuku, Okinawa, Japan
NHO Ureshino Medical Center
Ureshino, Saga-ken, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Kaneko Clinic
Kawaguchi, Saitama, Japan
Azuma Rheumatology Clinic
Sayama, Saitama, Japan
Hirose Clinic
Tokorozawa, Saitama, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Tokyo Women's Medical University East Medical Center
Arakawa-ku, Tokyo, Japan
St. Lukes International Hospital
Chuo-Ku, Tokyo, Japan
Fujimori Clinic
Hachiōji, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
National Tokyo Medical Center
Meguro-Ku, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Takaoka Rheumatic Orthopedic CL
Takaoka, Toyama, Japan
Miyasato Clinic
Shūnan, Yamaguchi, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Kondo Clinic for Rheumatism and Orthopaedics
Fukuoka, , Japan
Medical Co. LTA Fukuoka Mirai Hospital
Fukuoka, , Japan
Shono Rheumatism Clinic
Fukuoka, , Japan
Hiroshima Rheumatology Clinic
Hiroshima, , Japan
Hiroshima Clinic
Hiroshima, , Japan
Kagoshima Red Cross Hospital
Kagoshima, , Japan
Kumamoto Rheumatology Clinic
Kumamoto, , Japan
Kumamoto Orthopedic Hospital
Kumamoto, , Japan
Kumamoto Shinto General hospital
Kumamoto, , Japan
Nagano Red Cross Hospital
Nagano, , Japan
Nagasaki Medical Hospital of Rheumatology
Nagasaki, , Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, , Japan
Okayama Saiseikai General Hospital Outpatient Center
Okayama, , Japan
Okayama University Hospital
Okayama, , Japan
Japanese Red Cross Okayama Hospital
Okayama, , Japan
Yokota Clinic for Rheumatology
Osaka, , Japan
Oribe Clinic Rheumatism and Medicine
Ōita, , Japan
Shizuoka Rheumatism orthopedic Rehabilitation Hospital
Shizuoka, , Japan
JA-Shizuoka Shizuoka-Kosei General Hospital
Shizuoka, , Japan
Rheumatology Practice in Jaunliepaja Primary Health Care Cen
Liepāja, , Latvia
Pauls Stradins Kliniska Universitates Slimnica
Riga, , Latvia
Dr. Sarmite Saleniece
Valmiera, , Latvia
Dr. Kildos Klinika
Kaunas, , Lithuania
Klaipedos Universitetine Ligonine
Klaipėda, , Lithuania
Respublikine Siauliu Ligonine
Šiauliai, , Lithuania
Ctro Inv en Artritis y Osteoporosis SC
Mexicali, Estado de Baja California, Mexico
Centro de Investigacion del Noroeste
Tijuana, Estado de Baja California, Mexico
Centro Integral en Reumatologia SA de CV
Guadalajara, Jalisco, Mexico
Unidad de Investigacion en Enfermedades Cronico Degenerative
Guadalajara, Jalisco, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, Mexico
Private Service
Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigacion Basica y Clinica, S.C.
Guadalajara, Jalisco, Mexico
Mexico Centre for Clinical Research SA de CV
Mexico City, Mexico City, Mexico
RM Pharma Specialists S.A. de C.V.
Mexico City, Mexico City, Mexico
Hospital de Jesus I.A.P.
Mexico City, Mexico City, Mexico
Comite Mexicano para la Prevencion de la Osteoporosis A.C.
Mexico City, Mexico City, Mexico
Mentrials S.A. de C.V
Mexico City, Mexico City, Mexico
Hospital Universitario de Monterrey
Monterrey, Nuevo León, Mexico
Centro Medico de las Americas
Mérida, Yucatán, Mexico
Medical Care and Research, S.A. de C.V.
Mérida, Yucatán, Mexico
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
San Luis Potosí City, , Mexico
Ziekenhuisgroep Twente, Almelo
Almelo, , Netherlands
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Bydgoszcz, , Poland
Ambulatorium Barbara Bazela
Elblag, , Poland
Centrum Medyczne Pratia Katowice
Katowice, , Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, , Poland
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, , Poland
REUMATIKA - Centrum Reumatologii
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
Hospital Garcia da Orta
Almada, , Portugal
Instituto Portugues de Reumatologia
Lisbon, , Portugal
Hospital do Conde de Bertiandos
Ponte de Lima, , Portugal
Hospital Geral de Santo Antonio
Porto, , Portugal
Hospital de Sao Joao E.P.E.
Porto, , Portugal
Ramon L. Ortega Colon
Carolina, PR, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, Puerto Rico
Latin Clinical Trial Center
San Juan, PR, Puerto Rico
Mindful Medical Research
San Juan, PR, Puerto Rico
Barbara Diaz Hernandez
San Juan, PR, Puerto Rico
Spital Clinic Judetean de Urgenta Tg.Mures
Tg.Mures, Mureș County, Romania
SC DUO Medical S.R.L Rheumatology
Bucharest, , Romania
Spitalul Clinic Sf Maria Bucuresti
Bucharest, , Romania
Spitalul Clinic "Dr. Ioan Cantacuzino"
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
Constanța, , Romania
Spitalul Clinic de Recuperare Iasi
Iași, , Romania
Gbuz Lokb
Saint-Petersburg, Leningradskaya Oblast', Russia
GUZ UOKB
Ulyanovsk, Ulyanovsk Oblast, Russia
Family Clinic No 4
Korolyov, , Russia
V.A. Nasonova Research Institute of Rheumatology
Moscow, , Russia
City Clinical Hospital 1 named after N.I. Pirogov
Moscow, , Russia
First Moscow State Medical University
Moscow, , Russia
Ryazan Regional Clinincal Cardiology Dispensary
Ryazan, , Russia
Clinical Rheumatology Hospital # 25
Saint Petersburg, , Russia
Saratov Regional Clinical Hospital
Saratov, , Russia
Clinical Emergency Hospital N.V.Solovyov
Yaroslavl, , Russia
Nestatna reumatologicka ambulancia
Bratislava, , Slovakia
ROMJAN s.r.o.
Bratislava, , Slovakia
Reumacentrum s.r.o.
Partizánske, , Slovakia
REUMED s.r.o.
Spišská Nová Ves, , Slovakia
LERAM s.r.o.
Topoľčany, , Slovakia
Bolnisnica Dr. P. Drzaja UKCLJ
Ljubljana, , Slovenia
Netcare Greenacres Hospital
Port Elizabeth, Eastern Cape, South Africa
Saint Augustine's Hospital
Durban, KZ-Natal, South Africa
Precise Clinical Solutions (Pty) Ltd
Durban, KZ-Natal, South Africa
Arthritis Clinical Trial Centre
Cape Town, Western Cape, South Africa
Somerset West Trial Centre
Somerset West, Western Cape, South Africa
Winelands Medical Research Centre
Stellenbosch, Western Cape, South Africa
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Kyung Pook National University Hospital
Daegu, Korea, South Korea
Daegu Catholic University Medical Center
Daegu, Korea, South Korea
Chungnam National University Hospital
Daejeon, Korea, South Korea
Chonnam National University Hospital
Gwangju, Korea, South Korea
Gachon University Gil Medical Center
Incheon, Korea, South Korea
Inha University Hospital
Incheon, Korea, South Korea
Kyung Hee University Hospital
Seoul, Korea, South Korea
Seoul National University Hospital
Seoul, Korea, South Korea
Hanyang University Medical Center
Seoul, Korea, South Korea
Kyunghee University Hospital at Gangdong
Seoul, Korea, South Korea
Asan Medical Center
Seoul, Korea, South Korea
Seoul St. Mary's Hospital
Seoul, Korea, South Korea
Seoul Municipal Boramae Hospital
Seoul, Korea, South Korea
Catholic University of Korea Yeouido St. Mary's Hospital
Seoul, Korea, South Korea
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Hospital Marina Baixa
Villajoyosa, Alicante, Spain
Hospital Quiron Infanta Luisa
Seville, Andalusia, Spain
Corporacion Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Marques De Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Getafe
Getafe, Madrid, Spain
Hospital De Basurto
Bilbao, Vizcaya, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario La Fe de Valencia
Valencia, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Gothenburg, Sweden
Reumatologiska Kliniken Skånes universitetssjukhus Malmö
Malmo, , Sweden
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland
HFR Fribourg - Hôpital Cantonal
Fribourg, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, , Taiwan
Tri-Service General Hospital
Neihu Taipei, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
MacKay Memorial Hospital
Taipei, , Taiwan
Cathay General Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chi-Mei Medical Center
Yongkang District, , Taiwan
Trakya University
Edirne, , Turkey (Türkiye)
Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire, United Kingdom
Southampton General Hospital
Southampton, Hants, United Kingdom
Whipps Cross University Hospital
London, Surrey, United Kingdom
Guy's Hospital
London, Surrey, United Kingdom
Northumbria Healthcare NHS Foundation Trust
Newcastle upon Tyne, Tyneside, United Kingdom
St Lukes Hospital
Bradford, West Yorkshire, United Kingdom
Countries
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References
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Caporali R, Taylor PC, Aletaha D, Sanmarti R, Takeuchi T, Mo D, Haladyj E, Bello N, Zaremba-Pechmann L, Fang Y, Dougados M. Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis up to 6.5 years of treatment: results of a long-term study. Rheumatology (Oxford). 2024 Oct 1;63(10):2799-2809. doi: 10.1093/rheumatology/keae012.
Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24.
Fleischmann R, Takeuchi T, Schiff M, Schlichting D, Xie L, Issa M, Stoykov I, Lisse J, Martinez-Osuna P, Rooney T, Zerbini CAF. Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate. Arthritis Care Res (Hoboken). 2020 Aug;72(8):1112-1121. doi: 10.1002/acr.24007.
Tanaka Y, Fautrel B, Keystone EC, Ortmann RA, Xie L, Zhu B, Issa M, Patel H, Gaich CL, de Bono S, Rooney TP, Taylor PC. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis. Ann Rheum Dis. 2019 Jul;78(7):890-898. doi: 10.1136/annrheumdis-2018-214529. Epub 2019 Apr 30.
Winthrop KL, Bingham CO 3rd, Komocsar WJ, Bradley J, Issa M, Klar R, Kartman CE. Evaluation of pneumococcal and tetanus vaccine responses in patients with rheumatoid arthritis receiving baricitinib: results from a long-term extension trial substudy. Arthritis Res Ther. 2019 Apr 18;21(1):102. doi: 10.1186/s13075-019-1883-1.
Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15.
Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.
Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I4V-MC-JADY
Identifier Type: OTHER
Identifier Source: secondary_id
2012-003686-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14060
Identifier Type: -
Identifier Source: org_study_id
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