A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
NCT ID: NCT02706873
Last Updated: 2023-07-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1002 participants
INTERVENTIONAL
2016-02-23
2022-11-10
Brief Summary
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* To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA;
* To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA.
The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.
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Detailed Description
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* Group 1: Upadacitinib 7.5 mg once daily (QD) monotherapy (participants in Japan only)
* Group 2: Upadacitinib 15 mg QD monotherapy
* Group 3: Upadacitinib 30 mg QD monotherapy
* Group 4: Methotrexate monotherapy
Rescue therapy is defined for Weeks 12 through 24, Week 26, and Weeks 36 through 40. Starting at Week 12 through Week 24, participants who do not achieve ≥ 20% improvement in both tender joint count (TJC) and swollen joint count (SJC) compared with baseline at two consecutive visits will continue on their blinded therapy and the Investigator should optimize (initiate or increase) background RA medications: non-steroidal anti-inflammatory drug(s) (NSAIDs), corticosteroids (oral ≤ 10 mg/day prednisone equivalent or prednisone equivalent ≤ 0.5 mg/kg/day for 3 consecutive days) and/or low-potency analgesics.
Rescue therapy for participants who meet the following criteria at Week 26 are as follows:
Participants who do not achieve clinical remission (CR) based on Clinical Disease Activity Index (CDAI) (defined as a CDAI score ≤ 2.8):
* but achieve ≥ 20% improvement in both TJC and SJC compared with baseline will continue on blinded study drug and the Investigator should optimize (initiate or increase) background RA medications: NSAIDs, corticosteroids (oral ≤ 10 mg/day prednisone equivalent and up to 2 local injections), low-potency analgesics and conventional synthetic disease-modifying anti-rheumatic drug(s) (csDMARDs) (only 1 of the following: sulfasalazine, hydroxychloroquine or chloroquine) throughout the remainder of Period 1 and until the study is unblinded.
* and do not achieve ≥ 20% improvement in both TJC and SJC compared with baseline and originally assigned to methotrexate will be re-randomized in a 1:1 ratio to receive blinded upadacitinib 15 mg QD or upadacitinib 30 mg QD (participants in Japan will be randomized 1:1:1 to receive upadacitinib 7.5 mg QD, 15 mg QD, or 30 mg QD) while continuing methotrexate treatment in a blinded manner until the study is unblinded. Participants originally assigned to upadacitinib will add methotrexate 10 mg/week (7.5 mg for Japan) to upadacitinib in a blinded manner and will remain on upadacitinib plus methotrexate 10 mg/week (7.5 mg for Japan) until the study is unblinded.
Starting at Week 36 through Week 40, participants who do not achieve ≥ 20% improvement in both TJC and SJC compared with baseline at two consecutive visits will continue on their blinded therapy and the Investigator should optimize (initiate or increase) background RA medications: NSAIDs, corticosteroids (oral ≤ 10 mg/day prednisone equivalent or prednisone equivalent ≤ 0.5 mg/kg/day for 3 consecutive days and up to 2 local injections), low-potency analgesics and csDMARDs (only 1 of the following: sulfasalazine, hydroxychloroquine or chloroquine).
Participants who complete the Week 48 visit (end of Period 1) will enter the long-term extension, Period 2 (212 weeks) and continue study treatment per assignment at the end of Period 1 in a blinded fashion. When the last participant completes the last visit of Period 1 (Week 48), study drug assignment in both periods may be unblinded, and participants will be dispensed study drug in an open-label fashion until the completion of Period 2. Starting with Protocol Amendment 6, participants receiving upadacitinib 15 mg and 30 mg QD will receive open-label upadacitinib 15 mg QD, and participants receiving methotrexate will receive open-label methotrexate.
A global analysis will be conducted for the comparisons of the primary and secondary efficacy endpoints between the upadacitinib 15 mg QD and 30 mg QD treatment groups versus the methotrexate treatment group for all participants (excluding the Japan specific upadacitinib 7.5 mg treatment group). Analyses will be conducted separately for United States (US)/Food and Drug Administration (FDA), European Union (EU)/European Medicines Agency (EMA), and Japan/Pharmaceuticals and Medical Devices Agency (PMDA) regulatory purposes, each according to a pre-specified sequence of primary and ranked secondary endpoints.
A separate Japan sub-study analysis will be conducted for the comparisons of the efficacy endpoints between the upadacitinib 7.5 mg QD, 15 mg QD, and 30 mg QD treatment groups versus the methotrexate treatment group for participants enrolled in Japan only.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Group 1: Upadacitinib 7.5 mg QD monotherapy (Japan only)
Group 2: Upadacitinib 15 mg QD monotherapy (43 countries, including Japan)
Group 3: Upadacitinib 30 mg QD monotherapy (43 countries, including Japan)
Group 4: MTX monotherapy (43 countries, including Japan)
TREATMENT
QUADRUPLE
Study Groups
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Methotrexate
Period 1: Participants will receive placebo to upadacitinib once daily and methotrexate once weekly for 48 weeks.
Period 2: Participants will continue on placebo to upadacitinib once daily and methotrexate once weekly until the study is unblinded, after which participants will receive open-label methotrexate up to Week 260.
Placebo to Upadacitinib
Tablet; Oral
Methotrexate
Capsule or Tablet; Oral
Upadacitinib 7.5 mg (Japan-only)
Period 1: Participants will receive upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly for 48 weeks.
Period 2: Participants will continue on upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 7.5 mg up to Week 260.
Placebo to Methotrexate
Capsule or Tablet; Oral
Upadacitinib
Tablet; Oral
Upadacitinib 15 mg
Period 1: Participants will receive upadacitinib 15 mg once daily and placebo to methotrexate once weekly for 48 weeks.
Period 2: Participants will continue on upadacitinib 15 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 15 mg up to Week 260.
Placebo to Methotrexate
Capsule or Tablet; Oral
Upadacitinib
Tablet; Oral
Upadacitinib 30 mg
Period 1: Participants will receive upadacitinib 30 mg once daily and placebo to methotrexate once weekly for 48 weeks.
Period 2: Participants will continue on upadacitinib 30 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 30 mg once daily. After implementation of Protocol Amendment 6 participants will receive upadacitinib 15 mg once daily up to Week 260.
Placebo to Methotrexate
Capsule or Tablet; Oral
Upadacitinib
Tablet; Oral
Interventions
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Placebo to Upadacitinib
Tablet; Oral
Methotrexate
Capsule or Tablet; Oral
Placebo to Methotrexate
Capsule or Tablet; Oral
Upadacitinib
Tablet; Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naïve to Methotrexate (MTX) or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.
* Participants with prior exposure to conventional synthetic disease-modifying anti-rheumatic drugs(csDMARDs) other than MTX may be enrolled if completed the washout period.
* Participant meets both of the following minimum disease activity criteria:
-≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
* high sensitivity C reactive protein (hsCRP) ≥ 5 mg/L (central lab, upper limit of normal \[ULN\] 2.87 mg/L at Screening Visit.
* Greater than or equal to 1 bone erosion on x-ray (by local reading) OR in the absence of documented bone erosion, both positive rheumatoid factor (RF) and positive anti-cyclic citrullinated peptide (anti CCP) autoantibodies are required at Screening.
* Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral corticosteroids (equivalent to prednisone ≤ 10 mg/day), or inhaled corticosteroids for stable medical conditions are allowed but must have been at a stable dose ≥ 1 week prior to the first dose of study drug.
Exclusion Criteria
* Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
* Prior exposure to any biologic disease-modifying anti-rheumatic drugs (bDMARDs).
* History of any arthritis with onset prior to age 17 years or current diagnosis, inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia \[currently with active symptoms\]. Current diagnosis of secondary Sjogren's Syndrome is permitted.
* Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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TriWest Research Associates- La Mesa /ID# 143738
La Mesa, California, United States
Desert Medical Advances /ID# 143730
Palm Desert, California, United States
International Medical Research - Daytona /ID# 143748
Daytona Beach, Florida, United States
FL Med Ctr and Research, Inc. /ID# 143724
Miami, Florida, United States
Millennium Research /ID# 143736
Ormond Beach, Florida, United States
Arthritis Research of Florida /ID# 143743
Palm Harbor, Florida, United States
Sarasota Arthritis Center /ID# 145978
Sarasota, Florida, United States
FL Med Clinic, PA /ID# 143744
Zephyrhills, Florida, United States
Deerbrook Medical Associates /ID# 143728
Vernon Hills, Illinois, United States
Four Rivers Clinical Research /ID# 143741
Paducah, Kentucky, United States
Ocean Rheumatology, PA /ID# 143737
Toms River, New Jersey, United States
Arthritis Rheumatic Back Disorder /ID# 143733
Voorhees Township, New Jersey, United States
Trinity Health Med Arts Clinic /ID# 143727
Minot, North Dakota, United States
STAT Research, Inc. /ID# 143750
Vandalia, Ohio, United States
Healthcare Research Consultant /ID# 143747
Tulsa, Oklahoma, United States
Advanced Rheumatology & Arthri /ID# 147947
Wexford, Pennsylvania, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 145653
Summerville, South Carolina, United States
West Tennessee Research Inst /ID# 143723
Jackson, Tennessee, United States
Dr. Ramesh Gupta /ID# 143732
Memphis, Tennessee, United States
Diagnostic Group Integrated He /ID# 152921
Beaumont, Texas, United States
Adriana Pop-Moody MD Clinic PA /ID# 147626
Corpus Christi, Texas, United States
Doctor's Hosp at Renaissance /ID# 156407
Edinburg, Texas, United States
MedResearch Inc. /ID# 156409
El Paso, Texas, United States
Rheumatic Disease Clin Res Ctr /ID# 151103
Houston, Texas, United States
Accurate Clinical Research /ID# 143749
Houston, Texas, United States
SW Rheumatology Res. LLC /ID# 143745
Mesquite, Texas, United States
Sun Research Institute /ID# 159546
San Antonio, Texas, United States
Accurate Clinical Management /ID# 159543
San Antonio, Texas, United States
NextGen Clinical Trials LLP /ID# 150930
San Antonio, Texas, United States
Arthritis Clinic of Central TX /ID# 159541
San Marcos, Texas, United States
Arthritis & Osteoporosis Clinic /ID# 159542
Waco, Texas, United States
Arthritis Clinic of N. VA, P.C /ID# 143734
Arlington, Virginia, United States
Aprillus Asistencia e Investig /ID# 149179
Capital Federal, Buenos Aires, Argentina
Iari /Id# 148595
San Isidro, Buenos Aires, Argentina
Instituto CAICI /ID# 143141
Rosario, Santa Fe Province, Argentina
Org Medica de Investigacion /ID# 143142
Buenos Aires, , Argentina
Consultora Integral de Salud S /ID# 143144
Córdoba, , Argentina
Centro Integral de Reumatologi /ID# 143143
San Miguel de Tucumán, , Argentina
Centro Medico Privado/Reuma /ID# 143140
San Miguel de Tucumán, , Argentina
Royal Prince Alfred Hospital /ID# 143149
Camperdown, New South Wales, Australia
Rheumatology Research Unit /ID# 143147
Maroochydore, Queensland, Australia
The Queen Elizabeth Hospital /ID# 143148
Woodville, South Australia, Australia
Southern Clinical Research Pty /ID# 143150
Hobart, Tasmania, Australia
Emeritus Research /ID# 143146
Camberwell, Victoria, Australia
First City Clinical Hospital /ID# 159020
Minsk, , Belarus
City Clinical Hospital #9 /ID# 145650
Minsk, , Belarus
Rhumaconsult SPRL /ID# 143158
Charleroi, Hainaut, Belgium
Algemeen Stedelijk Ziekenhuis /ID# 153504
Aalst, Oost-Vlaanderen, Belgium
UZ Gent /ID# 143157
Ghent, Oost-Vlaanderen, Belgium
ReumaClinic Genk /ID# 143159
Genk, , Belgium
CHU Ambroise Pare /ID# 152955
Mons, , Belgium
University Clinical Centre of the Republic of Srpska /ID# 143161
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 143162
Banja Luka, Republika Srpska, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 143164
Sarajevo, , Bosnia and Herzegovina
CIP - Centro Internacional de Pesquisa /ID# 143171
Goiânia, Goiás, Brazil
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 143169
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre /ID# 143168
Porto Alegre, Rio Grande do Sul, Brazil
LMK Sevicos Medicos S/S /ID# 143167
Porto Alegre, Rio Grande do Sul, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 143166
São Paulo, São Paulo, Brazil
CCBR Brasil /ID# 150925
Rio de Janeiro, , Brazil
MHAT Trimontsium /ID# 143173
Plovdiv, , Bulgaria
UMHAT Pulmed OOD /ID# 143176
Plovdiv, , Bulgaria
MHAT Kaspela /ID# 143172
Plovdiv, , Bulgaria
Diagnostic Consultative Center /ID# 143174
Sofia, , Bulgaria
UMHAT Sv. Ivan Rilski /ID# 143175
Sofia, , Bulgaria
Rheumatology Research Assoc /ID# 143206
Edmonton, Alberta, Canada
Manitoba Clinic /ID# 143203
Winnipeg, Manitoba, Canada
Ciads /Id# 143205
Winnipeg, Manitoba, Canada
CA Ctr for Clin Trials CCCT /ID# 159080
Thornhill, Ontario, Canada
Ctr. de Rheum de l'est du QC /ID# 151317
Rimouski, Quebec, Canada
Ctr de Inv Clinica del Sur /ID# 143208
Temuco, Región de la Araucanía, Chile
Someal /Id# 143207
Providencia, Santiago Metropolitan, Chile
Quantum Research LTDA. /ID# 143210
Puerto Varas, , Chile
Quantum Research Stgo. /ID# 145651
Santiago, , Chile
Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 143209
Santiago, , Chile
Investigaciones Medicas SSMSO /ID# 151685
Santiago, , Chile
Centro de Estudios Clinicos Qu /ID# 152913
Viña del Mar, , Chile
1st Aff Hosp of Bengbu Med Col /ID# 162974
Bengbu, Anhui, China
The 1st Aff Hosp Xiamen Univ /ID# 162076
Xiamen, Fujian, China
1st Aff Hosp of Shantou Univ /ID# 162968
Shantou, Guangdong, China
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 143214
Bogota, Cundinamarca, Colombia
Ctr Int de Reum del Caribe SAS /ID# 143211
Barranquilla, , Colombia
Riesgo de Fractura S.A - CAYRE /ID# 143212
Bogotá, , Colombia
Simedics IPS SAS /ID# 152572
Bogotá, , Colombia
Fund Inst de Reum F. Chalem /ID# 159544
Bogotá, , Colombia
Medicity S.A.S. /ID# 143213
Bucaramanga, , Colombia
Klinicki bolnicki centar Split /ID# 143216
Split, , Croatia
Clinical Hospital Dubrava /ID# 143217
Zagreb, , Croatia
Medical Center Kuna-Peric /ID# 143218
Zagreb, , Croatia
Poliklinika Bonifarm /ID# 143215
Zagreb, , Croatia
L.K.N. Arthrocentrum, s.r.o /ID# 143224
Hlučín, Moravskoslezský kraj, Czechia
CTCenter MaVe, s.r.o. /ID# 143226
Olomouc, Olomoucký kraj, Czechia
Nuselská poliklinika, Revmatologie /ID# 143232
Prague, Praha 4, Czechia
Nuselská poliklinika, Revmatologie /ID# 143233
Prague, Praha 4, Czechia
Thomayerova nemocnice /ID# 143228
Prague, Praha 4, Czechia
PV MEDICAL Services s.r.o. /ID# 143234
Zlín, Zlín, Czechia
Revmatologie, s.r.o. /ID# 143223
Brno, , Czechia
Revmatologie Bruntal, s.r.o /ID# 143220
Bruntál, , Czechia
RHEUMA s.r.o. /ID# 143230
Břeclav, , Czechia
Nemocnice Slany /ID# 143221
Slaný, , Czechia
Medical Plus, s.r.o. /ID# 143219
Uherské Hradište, , Czechia
Center of Clinical and Basic Research /ID# 143239
Tallinn, Harju, Estonia
Paernu Hospital /ID# 143238
Pärnu, , Estonia
East Tallinn Central Hospital /ID# 143240
Tallinn, , Estonia
North Estonian Medical Centre /ID# 145456
Tallinn, , Estonia
Uniklinik Koln /ID# 143248
Cologne, North Rhine-Westphalia, Germany
Rheumazentrum Ruhrgebiet /ID# 145652
Herne, North Rhine-Westphalia, Germany
Praxis Walter, Rendsburg /ID# 143250
Rendsburg, Schleswig-Holstein, Germany
Rheumaforschungszentrum II /ID# 143247
Hamburg, , Germany
Schoen Klinikum Hamburg Eilbek /ID# 143251
Hamburg, , Germany
LMU Klinikum der Universität München /ID# 143249
Munich, , Germany
University General Hospital Attikon /ID# 143252
Athens, Attica, Greece
Clinicas Hospital Herrera Ller /ID# 153715
Guatemala City, , Guatemala
Creer /Id# 153713
Guatemala City, , Guatemala
Clin Especializada Med Interna /ID# 153716
Guatemala City, , Guatemala
Clinica Medica Reumatologia /ID# 153714
Guatemala City, , Guatemala
Clinica Medica Reumatologia /ID# 153931
Guatemala City, , Guatemala
Queen Mary Hospital /ID# 143255
Hong Kong, , Hong Kong
Tuen Mun Hospital /ID# 143256
Tuenmen, , Hong Kong
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 143258
Miskolc, Borsod-Abauj Zemplen county, Hungary
Qualiclinic Kft. /ID# 143259
Budapest, Pest County, Hungary
Markusovszky Egyetemi Oktatókórház /ID# 143261
Szombathely, Vas County, Hungary
Hevizgyogyfurdo es Szent Andra /ID# 143257
Hévíz, , Hungary
Pest Megyei Flor Ferenc Korhaz /ID# 143260
Kistarcsa, , Hungary
Fejer Megyei Szent Gyorgy Korh /ID# 144724
Székesfehérvár, , Hungary
St Vincent's University Hosp /ID# 143262
Dublin, , Ireland
Barzilai Medical Center /ID# 144725
Ashkelon, , Israel
Rambam Health Care Campus /ID# 143263
Haifa, , Israel
Sheba Medical Center /ID# 145975
Ramat Gan, , Israel
Istituto Clinico Humanitas /ID# 147531
Rozzano, Milano, Italy
Azienda Ospedaliera Luigi Sacc /ID# 143270
Milan, , Italy
Fondazione IRCCS Policlinico /ID# 143265
Pavia, , Italy
A.O.U.I. di Verona Policlinico /ID# 143266
Verona, , Italy
Nagoya University Hospital /ID# 148031
Nagoya, Aichi-ken, Japan
NHO Toyohashi Medical Center /ID# 161033
Toyohashi, Aichi-ken, Japan
Teikyo University Chiba Medical Center /ID# 159618
Ichihara, Chiba, Japan
NHO Kyushu Medical Center /ID# 148263
Fukuoka, Fukuoka, Japan
NHO Kyushu Medical Center /ID# 148264
Fukuoka, Fukuoka, Japan
National Hospital Organization Asahikawa Medical Center /ID# 148021
Asahikawa, Hokkaido, Japan
Katayama Orthopedic Rheumatology Clinic /ID# 148029
Asahikawa, Hokkaido, Japan
Kobe University Hospital /ID# 153461
Kobe, Hyōgo, Japan
National Hospital Organization Sagamihara National Hospital /ID# 148019
Sagamihara-shi, Kanagawa, Japan
NHO Osaka Minami Med Ctr /ID# 148042
Osaka, Kawachinagano-shi, Japan
Bay Side Misato Medical Center /ID# 148256
Kochi, Kochi, Japan
Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148254
Kumamoto, Kumamoto, Japan
Kumamoto Orthopaedic Hospital /ID# 148054
Kumamoto, Kumamoto, Japan
Kumamoto Shinto General Hospital /ID# 148266
Kumamoto, Kumamoto, Japan
Sasebo Chuo Hospital /ID# 148261
Sasebo, Nagasaki, Japan
Nagaoka Red Cross Hospital /ID# 148018
Nagaoka-shi, Niigata, Japan
Japanese Red Cross Okayama Hospital /ID# 159619
Okayama, Okayama-ken, Japan
Kansai Medical University Hospital /ID# 159622
Hirakata-shi, Osaka, Japan
Osaka Medical College Hospital /ID# 159624
Takatsuki -shi, Osaka, Japan
Saitama Medical Center, Saitama Medical University /ID# 148015
Kawagoe-shi, Saitama, Japan
Jichi Medical University Hospital /ID# 159620
Shimotsuke-shi, Tochigi, Japan
Juntendo University Hospital /ID# 148050
Bunkyo-ku, Tokyo, Japan
St.Luke's International Hospital /ID# 148041
Chuo-ku, Tokyo, Japan
Toho University Ohashi Medical Center /ID# 148027
Meguro-ku, Tokyo, Japan
Keio University Hospital /ID# 148057
Shinjuku-ku, Tokyo, Japan
Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 148052
Shimonoseki-shi, Yamaguchi, Japan
National Hospital Organization Beppu Medical Center /ID# 161058
Beppu, , Japan
NHO Chiba-East-Hospital /ID# 148035
Chiba, , Japan
Sugimoto Rheumatology and Internal Medicine Clinic /ID# 148047
Fukui, , Japan
Shono Rheumatism Clinic /ID# 148046
Fukuoka, , Japan
Matsubara Mayflower Hospital /ID# 148033
Katō, , Japan
St. Mary's Hospital /ID# 148038
Kurume, , Japan
Kagawa University Hospital /ID# 148016
Kyoto, , Japan
Yu Family Clinic /ID# 148048
Miyagi, , Japan
Daido Hospital /ID# 160868
Nagoya, , Japan
Kondo Clinic for Ortho & Rheum /ID# 148032
Nagoya, , Japan
Shirahama Hamayu Hospital /ID# 148253
Nishimura, , Japan
Osaka City General Hospital /ID# 159617
Osaka, , Japan
Oribe Clinic of Rheumatology and Internal Medicine /ID# 156035
Ōita, , Japan
Sanuki Municipal Hospital /ID# 158842
Sanuki, , Japan
Sagawa Akira Rheumatology Clin /ID# 148043
Sapporo, , Japan
Sapporo City General Hospital /ID# 148037
Sapporo, , Japan
Hokkaido University Hospital /ID# 148262
Sapporo, , Japan
Hokkaido Medical Center for Rheumatic Diseases /ID# 148259
Sapporo, , Japan
Azuma Rheumatology Clinic /ID# 161050
Sayama, , Japan
Hikarigaoka Spellman Hospital /ID# 148020
Sendai, , Japan
Takaoka Rheumatic Orthopedic Clinic /ID# 148022
Takaoka, , Japan
National Hospital Organization Tokyo Medical Center /ID# 148040
Tokyo, , Japan
National Hospital Organization Shimoshizu National Hospital /ID# 148258
Yotsukaidō, , Japan
JSC Nat Scientific Med Res Ctr /ID# 143272
Astana, , Kazakhstan
Karaganda State Medical Univ /ID# 153431
Karaganda, , Kazakhstan
Semey State Medical University /ID# 152661
Semey, , Kazakhstan
Regional Clinical Hospital /ID# 147173
Shymkent, , Kazakhstan
LTD M+M Centers /ID# 143279
Ādaži, , Latvia
Hosp Lithuanian Univ Health Sc /ID# 143582
Kaunas, Kovno, Lithuania
Klaipeda University Hospital /ID# 143583
Klaipėda, , Lithuania
Vilnius University Hospital /ID# 143584
Vilnius, , Lithuania
Clinstile, S.A. de C.V. /ID# 143591
Cuauhtémoc, Mexico City, Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 153562
Mexico City, Mexico City, Mexico
Invest y Biomed de Chihuahua /ID# 143595
Chihuahua City, , Mexico
RM Pharma Specialists, S.A de C.V /ID# 143593
Mexico City, , Mexico
Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 143592
Mexico City, , Mexico
Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 143589
Mexico City, , Mexico
Centro Reumatologico de Queret /ID# 149493
Querétaro, , Mexico
Waikato Hospital /ID# 143602
Hamilton, Waikato Region, New Zealand
Middlemore Clinical Trials /ID# 143600
Auckland, , New Zealand
Porter Rheumatology Ltd /ID# 143601
Nelson, , New Zealand
Timaru Medical Specialists Ltd /ID# 143599
Timaru, , New Zealand
Medyczne Centrum Hetmanska /ID# 144726
Poznan, Greater Poland Voivodeship, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 143606
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne AMED /ID# 143604
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Pratia Warszawa /ID# 143608
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Pratia Gdynia /ID# 143607
Gdynia, Pomeranian Voivodeship, Poland
Silmedic Sp z o.o /ID# 143605
Katowice, Silesian Voivodeship, Poland
NZOZ Centrum Reumatologiczne /ID# 143603
Elblag, Warmian-Masurian Voivodeship, Poland
Instituto Portugues De Reumatologia /ID# 148313
Lisbon, Lisbon District, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 151009
Lisbon, Lisbon District, Portugal
Centro Hospitalar De Vila Nova /ID# 143615
Vila Nova de Gaia, Porto District, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 143613
Lisbon, , Portugal
Centro Hospitalar Baixo Vouga /ID# 153726
Porto, , Portugal
Centro Hospitalar de Sao Joao, EPE /ID# 153575
Porto, , Portugal
Unidade Local De Saude Do Alto Minho /ID# 143611
Viana do Castelo, , Portugal
Centro Hosp de Tondela-Viseu /ID# 143612
Viseu, , Portugal
Ponce School of Medicine /ID# 145657
Ponce, , Puerto Rico
GCM Medical Group /ID# 143618
San Juan, , Puerto Rico
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 143619
San Juan, , Puerto Rico
Spitalul Clinic Dr. I. Cantacuzino /ID# 143622
Bucharest, București, Romania
Spitalul Clinic Sf. Maria /ID# 143623
Bucharest, , Romania
Spitalul Clinic Sf. Maria /ID# 143625
Bucharest, , Romania
Spitalul Clinic Sf. Maria /ID# 143627
Bucharest, , Romania
Spitalul Clinic de Recuperare /ID# 143620
Iași, , Romania
Ecomed SRL /ID# 143629
Oradea, , Romania
Family Outpatient clinic#4,LLC /ID# 151010
Korolev, Moscow, Russia
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143641
Moscow, Moscow, Russia
LLC Medical Center /ID# 143647
Novosibirsk, Novosibirsk Oblast, Russia
LLC Novaya Klinika /ID# 143631
Pyatigorsk, Stavropol Kray, Russia
Kazan State Medical University /ID# 143645
Kazan', Tatarstan, Respublika, Russia
Tver Regional Clinical Hosp. /ID# 143639
Tver', Tver Oblast, Russia
Russian National Research Medi /ID# 143642
Moscow, , Russia
Orenburg Regional Clinical Hos /ID# 143630
Orenburg, , Russia
Republican Clin Hos n.a. Baran /ID# 143634
Petrozavodsk, , Russia
Ryazan State Medical Universit /ID# 143646
Ryazan, , Russia
Samara Regional Clinical Hosp /ID# 150928
Samara, , Russia
Reg Clin Hosp n.a. Kuvatova G. /ID# 143632
Ufa, , Russia
Ulyanovsk Regional Clin Hosp /ID# 143644
Ulyanovsk, , Russia
Voronezh State Medical Univers /ID# 150926
Voronezh, , Russia
Clinical Center Serbia /ID# 143649
Belgrade, Beograd, Serbia
Clinical Center Serbia /ID# 143650
Belgrade, Beograd, Serbia
Special Hospital for Rheuma /ID# 143648
Novi Sad, Vojvodina, Serbia
MEDMAN s.r.o. /ID# 143661
Martin, , Slovakia
Reumatologická ambulancia Reum.hapi s.r.o. /ID# 143657
Nové Mesto nad Váhom, , Slovakia
REUMACENTRUM s.r.o. /ID# 143653
Partizánske, , Slovakia
Slovak research center Team Member, Thermium s.r.o. /ID# 143663
Pieštany, , Slovakia
Slovak Research Center /ID# 143659
Púchov, , Slovakia
TIMMED spol. s r.o. /ID# 143664
Stará Lubovna, , Slovakia
Reumatologicka ambulancia, LER /ID# 143660
Topoľčany, , Slovakia
MEDEOS s.r.o. /ID# 143656
Trenčín, , Slovakia
REUMA-GLOBAL, s.r.o. /ID# 143655
Trnava, , Slovakia
ALBAMED s.r.o. /ID# 143654
Zvolen, , Slovakia
Reuma -MUDr. Maria Palasthyova /ID# 143662
Žiar nad Hronom, , Slovakia
Univ Medical Ctr Ljubljana /ID# 143667
Ljubljana, , Slovenia
Jakaranda Hosp, Emmed Research /ID# 143668
Pretoria, Gauteng, South Africa
Jakaranda Hosp, Emmed Research /ID# 145976
Pretoria, Gauteng, South Africa
Arthritis Clinical Research Tr /ID# 143670
Cape Town, Western Cape, South Africa
Winelands Medical Research Ctr /ID# 143669
Stellenbosch, Western Cape, South Africa
H. Un. Marques de Valdecilla /ID# 143671
Santander, Cantabria, Spain
Comple Hosp Univ de A Coruna /ID# 143672
A Coruña, , Spain
Hospital Univ Vall d'Hebron /ID# 143675
Barcelona, , Spain
Hospital Clin Univ San Carlos /ID# 143674
Madrid, , Spain
Clinica Gaias /ID# 143673
Santiago de Compostela, , Spain
Hosp Nuestra Senora Esperanza /ID# 143677
Santiago de Compostela, , Spain
HFR Fribourg - Hopital Canton /ID# 143700
Fribourg, , Switzerland
China Medical University Hosp /ID# 143703
Taichung, Taichung, Taiwan
National Taiwan Univ Hosp /ID# 143702
Taipei City, Taipei, Taiwan
Dalin Tzu Chi General Hospital /ID# 153535
Dalin, , Taiwan
Hopital Mongi Slim /ID# 152870
La Marsa, , Tunisia
Institut Mohamed Kassab /ID# 152869
Manouba, , Tunisia
Hopital Farhat Hached /ID# 152868
Sousse, , Tunisia
Charles Nicolle Univ Hosp /ID# 152866
Tunis, , Tunisia
Hospital La Rabta /ID# 152867
Tunis, , Tunisia
Uludag Universitesi Ataturk Rehabilitasyon ve Uygulama Merkezi /ID# 143705
Osmangazi, Bursa, Turkey (Türkiye)
Izmir Tepecik Training and Research Hospital /ID# 157863
Konak, İzmir, Turkey (Türkiye)
Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143704
Izmir, , Turkey (Türkiye)
Lviv Regional Clinical Hospita /ID# 154449
Lviv, Lviv Oblast, Ukraine
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143714
Vinnytsia, Vinnytsia Oblast, Ukraine
Regional Clinical Hospital /ID# 152029
Ivano-Frankivsk, , Ukraine
NSC-Strazhesko Ist Cardiology /ID# 152026
Kiev, , Ukraine
LLC Revmocentr /ID# 143710
Kyiv, , Ukraine
MNCE "Lviv City Clinical Hospital #4" /ID# 143711
Lviv, , Ukraine
Odessa National Medical Univ /ID# 143715
Odesa, , Ukraine
Zaporizhzhia Regional Clinical /ID# 143712
Zaporizhia, , Ukraine
Leicester Royal Infirmary /ID# 143718
Leicester, England, United Kingdom
Whipps Cross Univ Hospital /ID# 143721
London, London, City of, United Kingdom
Western General Hospital /ID# 144431
Edinburgh, , United Kingdom
Chapel Allerton Hospital /ID# 143717
Leeds, , United Kingdom
Queen Alexandra Hospital /ID# 143722
Portsmouth, , United Kingdom
Southampton General Hospital /ID# 143716
Southampton, , United Kingdom
Countries
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References
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van Vollenhoven R, Takeuchi T, Pangan AL, Friedman A, Mohamed MF, Chen S, Rischmueller M, Blanco R, Xavier RM, Strand V. Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial. Arthritis Rheumatol. 2020 Oct;72(10):1607-1620. doi: 10.1002/art.41384. Epub 2020 Sep 8.
Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.
van Vollenhoven R, Strand V, Takeuchi T, Chavez N, Walter PM, Singhal A, Swierkot J, Khan N, Bu X, Li Y, Penn SK, Camp HS, Aelion J. Upadacitinib monotherapy versus methotrexate monotherapy in patients with rheumatoid arthritis: efficacy and safety through 5 years in the SELECT-EARLY randomized controlled trial. Arthritis Res Ther. 2024 Jul 29;26(1):143. doi: 10.1186/s13075-024-03358-x.
Rubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.
Charles-Schoeman C, Choy E, McInnes IB, Mysler E, Nash P, Yamaoka K, Lippe R, Khan N, Shmagel AK, Palac H, Suboticki J, Curtis JR. MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. RMD Open. 2023 Nov;9(4):e003392. doi: 10.1136/rmdopen-2023-003392.
Fleischmann R, Curtis JR, Charles-Schoeman C, Mysler E, Yamaoka K, Richez C, Palac H, Dilley D, Liu J, Strengholt S, Burmester G. Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme. Ann Rheum Dis. 2023 Sep;82(9):1130-1141. doi: 10.1136/ard-2023-223916. Epub 2023 Jun 12.
Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.
Kakehasi AM, Radominski SC, Baravalle MD, Palazuelos FCI, Garcia-Garcia C, Arruda MS, Curi M, Liu J, Qiao M, Velez-Sanchez P, Vargas JI. Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program. Clin Rheumatol. 2023 May;42(5):1249-1258. doi: 10.1007/s10067-023-06513-y. Epub 2023 Jan 30.
Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.
Peterfy CG, Strand V, Friedman A, Hall S, Mysler E, Durez P, Baraliakos X, Enejosa JV, Shaw T, Li Y, Chen S, Song IH. Inhibition of structural joint damage progression with upadacitinib in rheumatoid arthritis: 1-year outcomes from the SELECT phase 3 program. Rheumatology (Oxford). 2022 Aug 3;61(8):3246-3256. doi: 10.1093/rheumatology/keab861.
Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.
Strand V, Tundia N, Wells A, Buch MH, Radominski SC, Camp HS, Friedman A, Suboticki JL, Dunlap K, Goldschmidt D, Bergman M. Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY. Rheumatology (Oxford). 2021 Jul 1;60(7):3209-3221. doi: 10.1093/rheumatology/keaa770.
Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28.
Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info.
Other Identifiers
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2015-003334-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M13-545
Identifier Type: -
Identifier Source: org_study_id
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