Back to resultsA Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate (SELECT-EARLY)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo to Upadacitinib
Methotrexate
Placebo to Methotrexate
Upadacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Musculoskeletal disease, Arthritis, Joint disease, Anti-inflammatory agents, Antirheumatic agents, ABT-494, Upadacitinib
Eligibility Criteria
Inclusion Criteria:
- Duration of symptoms consistent with RA for ≥ 6 weeks who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
- 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:
- Intolerant to Methotrexate (MTX).
- 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.
Sites / Locations
- TriWest Research Associates- La Mesa /ID# 143738
- Desert Medical Advances /ID# 143730
- International Medical Research - Daytona /ID# 143748
- FL Med Ctr and Research, Inc. /ID# 143724
- Millennium Research /ID# 143736
- Arthritis Research of Florida /ID# 143743
- Sarasota Arthritis Center /ID# 145978
- FL Med Clinic, PA /ID# 143744
- Deerbrook Medical Associates /ID# 143728
- Four Rivers Clinical Research /ID# 143741
- Ocean Rheumatology, PA /ID# 143737
- Arthritis Rheumatic Back Disorder /ID# 143733
- Trinity Health Med Arts Clinic /ID# 143727
- STAT Research, Inc. /ID# 143750
- Healthcare Research Consultant /ID# 143747
- Advanced Rheumatology & Arthri /ID# 147947
- Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 145653
- West Tennessee Research Inst /ID# 143723
- Dr. Ramesh Gupta /ID# 143732
- Diagnostic Group Integrated He /ID# 152921
- Adriana Pop-Moody MD Clinic PA /ID# 147626
- Doctor's Hosp at Renaissance /ID# 156407
- MedResearch Inc. /ID# 156409
- Rheumatic Disease Clin Res Ctr /ID# 151103
- Accurate Clinical Research /ID# 143749
- SW Rheumatology Res. LLC /ID# 143745
- Sun Research Institute /ID# 159546
- Accurate Clinical Management /ID# 159543
- NextGen Clinical Trials LLP /ID# 150930
- Arthritis Clinic of Central TX /ID# 159541
- Arthritis & Osteoporosis Clinic /ID# 159542
- Arthritis Clinic of N. VA, P.C /ID# 143734
- Aprillus Asistencia e Investig /ID# 149179
- Iari /Id# 148595
- Instituto CAICI /ID# 143141
- Org Medica de Investigacion /ID# 143142
- Consultora Integral de Salud S /ID# 143144
- Centro Integral de Reumatologi /ID# 143143
- Centro Medico Privado/Reuma /ID# 143140
- Royal Prince Alfred Hospital /ID# 143149
- Rheumatology Research Unit /ID# 143147
- The Queen Elizabeth Hospital /ID# 143148
- Southern Clinical Research Pty /ID# 143150
- Emeritus Research /ID# 143146
- First City Clinical Hospital /ID# 159020
- City Clinical Hospital #9 /ID# 145650
- Rhumaconsult SPRL /ID# 143158
- Algemeen Stedelijk Ziekenhuis /ID# 153504
- UZ Gent /ID# 143157
- ReumaClinic Genk /ID# 143159
- CHU Ambroise Pare /ID# 152955
- University Clinical Centre of the Republic of Srpska /ID# 143161
- University Clinical Centre of the Republic of Srpska /ID# 143162
- Clinical Center University of Sarajevo /ID# 143164
- CIP - Centro Internacional de Pesquisa /ID# 143171
- Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 143169
- Hospital de Clinicas de Porto Alegre /ID# 143168
- LMK Sevicos Medicos S/S /ID# 143167
- CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 143166
- CCBR Brasil /ID# 150925
- MHAT Trimontsium /ID# 143173
- UMHAT Pulmed OOD /ID# 143176
- MHAT Kaspela /ID# 143172
- Diagnostic Consultative Center /ID# 143174
- UMHAT Sv. Ivan Rilski /ID# 143175
- Rheumatology Research Assoc /ID# 143206
- Manitoba Clinic /ID# 143203
- Ciads /Id# 143205
- CA Ctr for Clin Trials CCCT /ID# 159080
- Ctr. de Rheum de l'est du QC /ID# 151317
- Ctr de Inv Clinica del Sur /ID# 143208
- Someal /Id# 143207
- Quantum Research LTDA. /ID# 143210
- Quantum Research Stgo. /ID# 145651
- Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 143209
- Investigaciones Medicas SSMSO /ID# 151685
- Centro de Estudios Clinicos Qu /ID# 152913
- 1st Aff Hosp of Bengbu Med Col /ID# 162974
- The 1st Aff Hosp Xiamen Univ /ID# 162076
- 1st Aff Hosp of Shantou Univ /ID# 162968
- Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 143214
- Ctr Int de Reum del Caribe SAS /ID# 143211
- Riesgo de Fractura S.A - CAYRE /ID# 143212
- Simedics IPS SAS /ID# 152572
- Fund Inst de Reum F. Chalem /ID# 159544
- Medicity S.A.S. /ID# 143213
- Klinicki bolnicki centar Split /ID# 143216
- Clinical Hospital Dubrava /ID# 143217
- Medical Center Kuna-Peric /ID# 143218
- Poliklinika Bonifarm /ID# 143215
- L.K.N. Arthrocentrum, s.r.o /ID# 143224
- CTCenter MaVe, s.r.o. /ID# 143226
- Nuselská poliklinika, Revmatologie /ID# 143232
- Nuselská poliklinika, Revmatologie /ID# 143233
- Thomayerova nemocnice /ID# 143228
- PV MEDICAL Services s.r.o. /ID# 143234
- RHEUMA s.r.o. /ID# 143230
- Revmatologie, s.r.o. /ID# 143223
- Revmatologie Bruntal, s.r.o /ID# 143220
- Nemocnice Slany /ID# 143221
- Medical Plus, s.r.o. /ID# 143219
- Center of Clinical and Basic Research /ID# 143239
- Paernu Hospital /ID# 143238
- East Tallinn Central Hospital /ID# 143240
- North Estonian Medical Centre /ID# 145456
- Rheumazentrum Ruhrgebiet /ID# 145652
- Uniklinik Koln /ID# 143248
- Praxis Walter, Rendsburg /ID# 143250
- Rheumaforschungszentrum II /ID# 143247
- Schoen Klinikum Hamburg Eilbek /ID# 143251
- LMU Klinikum der Universität München /ID# 143249
- University General Hospital Attikon /ID# 143252
- Clinicas Hospital Herrera Ller /ID# 153715
- Creer /Id# 153713
- Clin Especializada Med Interna /ID# 153716
- Clinica Medica Reumatologia /ID# 153714
- Clinica Medica Reumatologia /ID# 153931
- Queen Mary Hospital /ID# 143255
- Tuen Mun Hospital /ID# 143256
- CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 143258
- Qualiclinic Kft. /ID# 143259
- Markusovszky Egyetemi Oktatókórház /ID# 143261
- Hevizgyogyfurdo es Szent Andra /ID# 143257
- Pest Megyei Flor Ferenc Korhaz /ID# 143260
- Fejer Megyei Szent Gyorgy Korh /ID# 144724
- St Vincent's University Hosp /ID# 143262
- Barzilai Medical Center /ID# 144725
- Rambam Health Care Campus /ID# 143263
- Sheba Medical Center /ID# 145975
- Istituto Clinico Humanitas /ID# 147531
- Azienda Ospedaliera Luigi Sacc /ID# 143270
- Fondazione IRCCS Policlinico /ID# 143265
- A.O.U.I. di Verona Policlinico /ID# 143266
- Nagoya University Hospital /ID# 148031
- NHO Toyohashi Medical Center /ID# 161033
- Teikyo University Chiba Medical Center /ID# 159618
- NHO Kyushu Medical Center /ID# 148263
- NHO Kyushu Medical Center /ID# 148264
- National Hospital Organization Asahikawa Medical Center /ID# 148021
- Katayama Orthopedic Rheumatology Clinic /ID# 148029
- Kobe University Hospital /ID# 153461
- National Hospital Organization Sagamihara National Hospital /ID# 148019
- NHO Osaka Minami Med Ctr /ID# 148042
- Bay Side Misato Medical Center /ID# 148256
- Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148254
- Kumamoto Orthopaedic Hospital /ID# 148054
- Kumamoto Shinto General Hospital /ID# 148266
- Sasebo Chuo Hospital /ID# 148261
- Nagaoka Red Cross Hospital /ID# 148018
- Japanese Red Cross Okayama Hospital /ID# 159619
- Kansai Medical University Hospital /ID# 159622
- Osaka Medical College Hospital /ID# 159624
- Saitama Medical Center, Saitama Medical University /ID# 148015
- Jichi Medical University Hospital /ID# 159620
- Juntendo University Hospital /ID# 148050
- St.Luke's International Hospital /ID# 148041
- Toho University Ohashi Medical Center /ID# 148027
- Keio University Hospital /ID# 148057
- Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 148052
- National Hospital Organization Beppu Medical Center /ID# 161058
- NHO Chiba-East-Hospital /ID# 148035
- Sugimoto Rheumatology and Internal Medicine Clinic /ID# 148047
- Shono Rheumatism Clinic /ID# 148046
- Matsubara Mayflower Hospital /ID# 148033
- St. Mary's Hospital /ID# 148038
- Kagawa University Hospital /ID# 148016
- Yu Family Clinic /ID# 148048
- Daido Hospital /ID# 160868
- Kondo Clinic for Ortho & Rheum /ID# 148032
- Shirahama Hamayu Hospital /ID# 148253
- Oribe Clinic of Rheumatology and Internal Medicine /ID# 156035
- Osaka City General Hospital /ID# 159617
- Sanuki Municipal Hospital /ID# 158842
- Sagawa Akira Rheumatology Clin /ID# 148043
- Sapporo City General Hospital /ID# 148037
- Hokkaido University Hospital /ID# 148262
- Hokkaido Medical Center for Rheumatic Diseases /ID# 148259
- Azuma Rheumatology Clinic /ID# 161050
- Hikarigaoka Spellman Hospital /ID# 148020
- Takaoka Rheumatic Orthopedic Clinic /ID# 148022
- National Hospital Organization Tokyo Medical Center /ID# 148040
- National Hospital Organization Shimoshizu National Hospital /ID# 148258
- JSC Nat Scientific Med Res Ctr /ID# 143272
- Karaganda State Medical Univ /ID# 153431
- Semey State Medical University /ID# 152661
- Regional Clinical Hospital /ID# 147173
- LTD M+M Centers /ID# 143279
- Hosp Lithuanian Univ Health Sc /ID# 143582
- Klaipeda University Hospital /ID# 143583
- Vilnius University Hospital /ID# 143584
- Clinstile, S.A. de C.V. /ID# 143591
- CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 153562
- Invest y Biomed de Chihuahua /ID# 143595
- RM Pharma Specialists, S.A de C.V /ID# 143593
- Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 143592
- Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 143589
- Centro Reumatologico de Queret /ID# 149493
- Waikato Hospital /ID# 143602
- Middlemore Clinical Trials /ID# 143600
- Porter Rheumatology Ltd /ID# 143601
- Timaru Medical Specialists Ltd /ID# 143599
- WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 143606
- Centrum Medyczne AMED /ID# 143604
- Centrum Medyczne Pratia Warszawa /ID# 143608
- Centrum Medyczne Pratia Gdynia /ID# 143607
- Silmedic Sp z o.o /ID# 143605
- NZOZ Centrum Reumatologiczne /ID# 143603
- Medyczne Centrum Hetmanska /ID# 144726
- Instituto Portugues De Reumatologia /ID# 148313
- Centro Hospitalar Lisboa Ocidental, EPE /ID# 151009
- Centro Hospitalar De Vila Nova /ID# 143615
- Centro Hospitalar Lisboa Norte, EPE /ID# 143613
- Centro Hospitalar Baixo Vouga /ID# 153726
- Centro Hospitalar de Sao Joao, EPE /ID# 153575
- Unidade Local De Saude Do Alto Minho /ID# 143611
- Centro Hosp de Tondela-Viseu /ID# 143612
- Ponce School of Medicine /ID# 145657
- GCM Medical Group /ID# 143618
- School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 143619
- Spitalul Clinic Dr. I. Cantacuzino /ID# 143622
- Spitalul Clinic Sf. Maria /ID# 143623
- Spitalul Clinic Sf. Maria /ID# 143625
- Spitalul Clinic Sf. Maria /ID# 143627
- Spitalul Clinic de Recuperare /ID# 143620
- Ecomed SRL /ID# 143629
- Family Outpatient clinic#4,LLC /ID# 151010
- Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143641
- LLC Medical Center /ID# 143647
- LLC Novaya Klinika /ID# 143631
- Kazan State Medical University /ID# 143645
- Tver Regional Clinical Hosp. /ID# 143639
- Russian National Research Medi /ID# 143642
- Orenburg Regional Clinical Hos /ID# 143630
- Republican Clin Hos n.a. Baran /ID# 143634
- Ryazan State Medical Universit /ID# 143646
- Samara Regional Clinical Hosp /ID# 150928
- Reg Clin Hosp n.a. Kuvatova G. /ID# 143632
- Ulyanovsk Regional Clin Hosp /ID# 143644
- Voronezh State Medical Univers /ID# 150926
- Clinical Center Serbia /ID# 143649
- Clinical Center Serbia /ID# 143650
- Special Hospital for Rheuma /ID# 143648
- MEDMAN s.r.o. /ID# 143661
- Reumatologická ambulancia Reum.hapi s.r.o. /ID# 143657
- REUMACENTRUM s.r.o. /ID# 143653
- Slovak research center Team Member, Thermium s.r.o. /ID# 143663
- Slovak Research Center /ID# 143659
- TIMMED spol. s r.o. /ID# 143664
- Reumatologicka ambulancia, LER /ID# 143660
- MEDEOS s.r.o. /ID# 143656
- REUMA-GLOBAL, s.r.o. /ID# 143655
- ALBAMED s.r.o. /ID# 143654
- Reuma -MUDr. Maria Palasthyova /ID# 143662
- Univ Medical Ctr Ljubljana /ID# 143667
- Jakaranda Hosp, Emmed Research /ID# 143668
- Jakaranda Hosp, Emmed Research /ID# 145976
- Arthritis Clinical Research Tr /ID# 143670
- Winelands Medical Research Ctr /ID# 143669
- H. Un. Marques de Valdecilla /ID# 143671
- Comple Hosp Univ de A Coruna /ID# 143672
- Hospital Univ Vall d'Hebron /ID# 143675
- Hospital Clin Univ San Carlos /ID# 143674
- Clinica Gaias /ID# 143673
- Hosp Nuestra Senora Esperanza /ID# 143677
- HFR Fribourg - Hopital Canton /ID# 143700
- China Medical University Hosp /ID# 143703
- National Taiwan Univ Hosp /ID# 143702
- Dalin Tzu Chi General Hospital /ID# 153535
- Hopital Mongi Slim /ID# 152870
- Institut Mohamed Kassab /ID# 152869
- Hopital Farhat Hached /ID# 152868
- Charles Nicolle Univ Hosp /ID# 152866
- Hospital La Rabta /ID# 152867
- Uludag Universitesi Ataturk Rehabilitasyon ve Uygulama Merkezi /ID# 143705
- Izmir Tepecik Training and Research Hospital /ID# 157863
- Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143704
- Lviv Regional Clinical Hospita /ID# 154449
- Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143714
- Regional Clinical Hospital /ID# 152029
- NSC-Strazhesko Ist Cardiology /ID# 152026
- LLC Revmocentr /ID# 143710
- MNCE "Lviv City Clinical Hospital #4" /ID# 143711
- Odessa National Medical Univ /ID# 143715
- Zaporizhzhia Regional Clinical /ID# 143712
- Leicester Royal Infirmary /ID# 143718
- Whipps Cross Univ Hospital /ID# 143721
- Western General Hospital /ID# 144431
- Chapel Allerton Hospital /ID# 143717
- Queen Alexandra Hospital /ID# 143722
- Southampton General Hospital /ID# 143716
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Methotrexate
Upadacitinib 7.5 mg (Japan-only)
Upadacitinib 15 mg
Upadacitinib 30 mg
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 - Global Analysis
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 50% response (ACR50) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Global Analysis
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 at Week 24.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 2.6 indicates clinical remission.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 - Global Analysis
The primary endpoint for Japan/Pharmaceuticals and Medical Devices Agency (PMDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Global Analysis
The second primary endpoint for Japan/PMDA regulatory purposes was change from baseline in mTSS at Week 24.
The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion was assessed in 16 joints in each hand/wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A change from Baseline greater than 0 indicates progression.
Secondary Outcome Measures
Change From Baseline in DAS28 (CRP) at Week 12 - Global Analysis
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Global Analysis
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Global Analysis
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Global Analysis
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Change From Baseline in DAS28 (CRP) at Week 24 - Global Analysis
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 - Global Analysis
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Percentage of Participants With an ACR50 Response at Week 24 - Global Analysis
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 24 - Global Analysis
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 24 - Global Analysis
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Percentage of Participants With No Radiographic Progression at Week 24 - Global Analysis
No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst).
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 - Global Analysis
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants With an ACR20 Response at Week 24 - Global Analysis
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants With an ACR70 Response at Week 24 - Global Analysis
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants With an ACR20 Response at Week 12 - Japan Sub-study
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants With an ACR50 Response at Week 12 - Japan Sub-study
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants With an ACR70 Response at Week 12 - Japan Sub-study
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Change From Baseline in DAS28 (CRP) at Week 12 - Japan Sub-study
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Japan Sub-study
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Japan Sub-study
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Japan Sub-study
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Japan Sub-study
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 2.6 indicates clinical remission.
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Japan Sub-study
The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion was assessed in 16 joints in each hand/wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A change from Baseline greater than 0 indicates progression.
Percentage of Participants With No Radiographic Progression at Week 24 - Japan Sub-study
No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02706873
Brief Title
A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
Acronym
SELECT-EARLY
Official Title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2016 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
November 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objectives of Period 1 were the following:
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.
Detailed Description
This study includes 2 periods (a 48-week double-blind treatment period and a long-term extension period) and a Japan substudy. In Period 1 participants will be randomized in a 1:1:1 ratio to treatment Groups 2, 3, and 4 below, except for participants from Japan, who will be randomized in a 2:1:1:1 ratio to Groups 1, 2, 3, and 4:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Musculoskeletal disease, Arthritis, Joint disease, Anti-inflammatory agents, Antirheumatic agents, ABT-494, Upadacitinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants were to be randomized in a 1:1:1 ratio to treatment Groups 2, 3, and 4 below, except for participants from Japan, who were to be randomized in a 2:1:1:1 ratio to Groups 1, 2, 3, and 4:
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)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1002 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methotrexate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Upadacitinib 7.5 mg (Japan-only)
Arm Type
Experimental
Arm Description
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.
Arm Title
Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo to Upadacitinib
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Capsule or Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Placebo to Methotrexate
Intervention Description
Capsule or Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, Rinvoq
Intervention Description
Tablet; Oral
Primary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 - Global Analysis
Description
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 50% response (ACR50) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Global Analysis
Description
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 at Week 24.
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 2.6 indicates clinical remission.
Time Frame
Week 24
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 - Global Analysis
Description
The primary endpoint for Japan/Pharmaceuticals and Medical Devices Agency (PMDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Title
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Global Analysis
Description
The second primary endpoint for Japan/PMDA regulatory purposes was change from baseline in mTSS at Week 24.
The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion was assessed in 16 joints in each hand/wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A change from Baseline greater than 0 indicates progression.
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in DAS28 (CRP) at Week 12 - Global Analysis
Description
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Global Analysis
Description
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Time Frame
Baseline to week 12
Title
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Global Analysis
Description
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
Time Frame
Week 12
Title
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Global Analysis
Description
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Time Frame
Baseline to week 12
Title
Change From Baseline in DAS28 (CRP) at Week 24 - Global Analysis
Description
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 - Global Analysis
Description
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Time Frame
Baseline to Week 24
Title
Percentage of Participants With an ACR50 Response at Week 24 - Global Analysis
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 24
Title
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 24 - Global Analysis
Description
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
Time Frame
Week 24
Title
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 24 - Global Analysis
Description
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Time Frame
Baseline to Week 24
Title
Percentage of Participants With No Radiographic Progression at Week 24 - Global Analysis
Description
No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst).
Time Frame
Week 24
Title
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 - Global Analysis
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an ACR20 Response at Week 24 - Global Analysis
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 24
Title
Percentage of Participants With an ACR70 Response at Week 24 - Global Analysis
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 24
Title
Percentage of Participants With an ACR20 Response at Week 12 - Japan Sub-study
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an ACR50 Response at Week 12 - Japan Sub-study
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an ACR70 Response at Week 12 - Japan Sub-study
Description
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Title
Change From Baseline in DAS28 (CRP) at Week 12 - Japan Sub-study
Description
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Japan Sub-study
Description
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Time Frame
Baseline to week 12
Title
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Japan Sub-study
Description
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Time Frame
Baseline to Week 12
Title
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Japan Sub-study
Description
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.
Time Frame
Week 12
Title
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Japan Sub-study
Description
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 2.6 indicates clinical remission.
Time Frame
Week 24
Title
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Japan Sub-study
Description
The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion was assessed in 16 joints in each hand/wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A change from Baseline greater than 0 indicates progression.
Time Frame
Baseline to Week 24
Title
Percentage of Participants With No Radiographic Progression at Week 24 - Japan Sub-study
Description
No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet. Joint erosion and joint space narrowing (JSN) were assessed by two independent, blinded readers.
Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).
Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).
The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst).
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Duration of symptoms consistent with RA for ≥ 6 weeks who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
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:
Intolerant to Methotrexate (MTX).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
TriWest Research Associates- La Mesa /ID# 143738
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Desert Medical Advances /ID# 143730
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
International Medical Research - Daytona /ID# 143748
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
FL Med Ctr and Research, Inc. /ID# 143724
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Millennium Research /ID# 143736
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Arthritis Research of Florida /ID# 143743
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684-2672
Country
United States
Facility Name
Sarasota Arthritis Center /ID# 145978
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
FL Med Clinic, PA /ID# 143744
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Deerbrook Medical Associates /ID# 143728
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Four Rivers Clinical Research /ID# 143741
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Ocean Rheumatology, PA /ID# 143737
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Arthritis Rheumatic Back Disorder /ID# 143733
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Trinity Health Med Arts Clinic /ID# 143727
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
STAT Research, Inc. /ID# 143750
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377-9464
Country
United States
Facility Name
Healthcare Research Consultant /ID# 143747
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Advanced Rheumatology & Arthri /ID# 147947
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 145653
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486-7887
Country
United States
Facility Name
West Tennessee Research Inst /ID# 143723
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Dr. Ramesh Gupta /ID# 143732
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Diagnostic Group Integrated He /ID# 152921
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Adriana Pop-Moody MD Clinic PA /ID# 147626
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Doctor's Hosp at Renaissance /ID# 156407
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
MedResearch Inc. /ID# 156409
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Rheumatic Disease Clin Res Ctr /ID# 151103
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Accurate Clinical Research /ID# 143749
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
SW Rheumatology Res. LLC /ID# 143745
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Sun Research Institute /ID# 159546
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Accurate Clinical Management /ID# 159543
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
NextGen Clinical Trials LLP /ID# 150930
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Arthritis Clinic of Central TX /ID# 159541
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic /ID# 159542
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Arthritis Clinic of N. VA, P.C /ID# 143734
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Aprillus Asistencia e Investig /ID# 149179
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1046
Country
Argentina
Facility Name
Iari /Id# 148595
City
San isidro
State/Province
Buenos Aires
ZIP/Postal Code
1646
Country
Argentina
Facility Name
Instituto CAICI /ID# 143141
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Org Medica de Investigacion /ID# 143142
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Consultora Integral de Salud S /ID# 143144
City
Cordoba
ZIP/Postal Code
5900
Country
Argentina
Facility Name
Centro Integral de Reumatologi /ID# 143143
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Centro Medico Privado/Reuma /ID# 143140
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Royal Prince Alfred Hospital /ID# 143149
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Rheumatology Research Unit /ID# 143147
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
The Queen Elizabeth Hospital /ID# 143148
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Southern Clinical Research Pty /ID# 143150
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Emeritus Research /ID# 143146
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
First City Clinical Hospital /ID# 159020
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
City Clinical Hospital #9 /ID# 145650
City
Minsk
ZIP/Postal Code
220116
Country
Belarus
Facility Name
Rhumaconsult SPRL /ID# 143158
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Algemeen Stedelijk Ziekenhuis /ID# 153504
City
Aalst
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9300
Country
Belgium
Facility Name
UZ Gent /ID# 143157
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
ReumaClinic Genk /ID# 143159
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
CHU Ambroise Pare /ID# 152955
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 143161
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 143162
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University of Sarajevo /ID# 143164
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
CIP - Centro Internacional de Pesquisa /ID# 143171
City
Goiânia
State/Province
Goias
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 143169
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 143168
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
LMK Sevicos Medicos S/S /ID# 143167
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 143166
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
CCBR Brasil /ID# 150925
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
MHAT Trimontsium /ID# 143173
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
UMHAT Pulmed OOD /ID# 143176
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT Kaspela /ID# 143172
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Diagnostic Consultative Center /ID# 143174
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
UMHAT Sv. Ivan Rilski /ID# 143175
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Rheumatology Research Assoc /ID# 143206
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
Manitoba Clinic /ID# 143203
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A IM3
Country
Canada
Facility Name
Ciads /Id# 143205
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3N 0K6
Country
Canada
Facility Name
CA Ctr for Clin Trials CCCT /ID# 159080
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 1W3
Country
Canada
Facility Name
Ctr. de Rheum de l'est du QC /ID# 151317
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 8W1
Country
Canada
Facility Name
Ctr de Inv Clinica del Sur /ID# 143208
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4781156
Country
Chile
Facility Name
Someal /Id# 143207
City
Providencia
State/Province
Santiago
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Quantum Research LTDA. /ID# 143210
City
Puerto Varas
ZIP/Postal Code
5550170
Country
Chile
Facility Name
Quantum Research Stgo. /ID# 145651
City
Santiago
ZIP/Postal Code
7500588
Country
Chile
Facility Name
Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 143209
City
Santiago
ZIP/Postal Code
7510047
Country
Chile
Facility Name
Investigaciones Medicas SSMSO /ID# 151685
City
Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Centro de Estudios Clinicos Qu /ID# 152913
City
Vina Del Mar
Country
Chile
Facility Name
1st Aff Hosp of Bengbu Med Col /ID# 162974
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233099
Country
China
Facility Name
The 1st Aff Hosp Xiamen Univ /ID# 162076
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
1st Aff Hosp of Shantou Univ /ID# 162968
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 143214
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Ctr Int de Reum del Caribe SAS /ID# 143211
City
Barranquilla
ZIP/Postal Code
80002
Country
Colombia
Facility Name
Riesgo de Fractura S.A - CAYRE /ID# 143212
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Simedics IPS SAS /ID# 152572
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Fund Inst de Reum F. Chalem /ID# 159544
City
Bogotá
Country
Colombia
Facility Name
Medicity S.A.S. /ID# 143213
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Klinicki bolnicki centar Split /ID# 143216
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Clinical Hospital Dubrava /ID# 143217
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Medical Center Kuna-Peric /ID# 143218
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Poliklinika Bonifarm /ID# 143215
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
L.K.N. Arthrocentrum, s.r.o /ID# 143224
City
Hlučín
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
748 01
Country
Czechia
Facility Name
CTCenter MaVe, s.r.o. /ID# 143226
City
Olomouc
State/Province
Olomoucky Kraj
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Nuselská poliklinika, Revmatologie /ID# 143232
City
Prague 4
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Nuselská poliklinika, Revmatologie /ID# 143233
City
Prague 4
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Thomayerova nemocnice /ID# 143228
City
Prague
State/Province
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
PV MEDICAL Services s.r.o. /ID# 143234
City
Zlín 1
State/Province
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
RHEUMA s.r.o. /ID# 143230
City
Breclav
ZIP/Postal Code
690 02
Country
Czechia
Facility Name
Revmatologie, s.r.o. /ID# 143223
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Revmatologie Bruntal, s.r.o /ID# 143220
City
Bruntál
ZIP/Postal Code
79201
Country
Czechia
Facility Name
Nemocnice Slany /ID# 143221
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Medical Plus, s.r.o. /ID# 143219
City
Uherské Hradište
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Center of Clinical and Basic Research /ID# 143239
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
10128
Country
Estonia
Facility Name
Paernu Hospital /ID# 143238
City
Pärnu
ZIP/Postal Code
80010
Country
Estonia
Facility Name
East Tallinn Central Hospital /ID# 143240
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
North Estonian Medical Centre /ID# 145456
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Rheumazentrum Ruhrgebiet /ID# 145652
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44649
Country
Germany
Facility Name
Uniklinik Koln /ID# 143248
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Praxis Walter, Rendsburg /ID# 143250
City
Rendsburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24768
Country
Germany
Facility Name
Rheumaforschungszentrum II /ID# 143247
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Schoen Klinikum Hamburg Eilbek /ID# 143251
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
LMU Klinikum der Universität München /ID# 143249
City
Munich
ZIP/Postal Code
80337
Country
Germany
Facility Name
University General Hospital Attikon /ID# 143252
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Facility Name
Clinicas Hospital Herrera Ller /ID# 153715
City
Ciudad de Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Creer /Id# 153713
City
Ciudad de Guatemala
ZIP/Postal Code
10010
Country
Guatemala
Facility Name
Clin Especializada Med Interna /ID# 153716
City
Ciudad de Guatemala
ZIP/Postal Code
1011
Country
Guatemala
Facility Name
Clinica Medica Reumatologia /ID# 153714
City
Ciudad de Guatemala
ZIP/Postal Code
1021
Country
Guatemala
Facility Name
Clinica Medica Reumatologia /ID# 153931
City
Ciudad de Guatemala
ZIP/Postal Code
1021
Country
Guatemala
Facility Name
Queen Mary Hospital /ID# 143255
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Tuen Mun Hospital /ID# 143256
City
Tuen Mun
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 143258
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Qualiclinic Kft. /ID# 143259
City
Budapest
State/Province
Pest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatókórház /ID# 143261
City
Szombathely
State/Province
Vas
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Hevizgyogyfurdo es Szent Andra /ID# 143257
City
Heviz
ZIP/Postal Code
8380
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz /ID# 143260
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korh /ID# 144724
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
St Vincent's University Hosp /ID# 143262
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Barzilai Medical Center /ID# 144725
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 143263
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Sheba Medical Center /ID# 145975
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Istituto Clinico Humanitas /ID# 147531
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Luigi Sacc /ID# 143270
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Fondazione IRCCS Policlinico /ID# 143265
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
A.O.U.I. di Verona Policlinico /ID# 143266
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Nagoya University Hospital /ID# 148031
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
NHO Toyohashi Medical Center /ID# 161033
City
Toyohashi-shi
State/Province
Aichi
ZIP/Postal Code
440-8510
Country
Japan
Facility Name
Teikyo University Chiba Medical Center /ID# 159618
City
Ichihara
State/Province
Chiba
ZIP/Postal Code
299-0111
Country
Japan
Facility Name
NHO Kyushu Medical Center /ID# 148263
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
NHO Kyushu Medical Center /ID# 148264
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center /ID# 148021
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Katayama Orthopedic Rheumatology Clinic /ID# 148029
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8243
Country
Japan
Facility Name
Kobe University Hospital /ID# 153461
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
National Hospital Organization Sagamihara National Hospital /ID# 148019
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-0315
Country
Japan
Facility Name
NHO Osaka Minami Med Ctr /ID# 148042
City
Osaka
State/Province
Kawachinagano-shi
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Bay Side Misato Medical Center /ID# 148256
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
781-0112
Country
Japan
Facility Name
Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148254
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-0920
Country
Japan
Facility Name
Kumamoto Orthopaedic Hospital /ID# 148054
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Kumamoto Shinto General Hospital /ID# 148266
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
8628655
Country
Japan
Facility Name
Sasebo Chuo Hospital /ID# 148261
City
Sasebo-city
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Nagaoka Red Cross Hospital /ID# 148018
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-2108
Country
Japan
Facility Name
Japanese Red Cross Okayama Hospital /ID# 159619
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7008607
Country
Japan
Facility Name
Kansai Medical University Hospital /ID# 159622
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Osaka Medical College Hospital /ID# 159624
City
Takatsuki -shi
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saitama Medical Center, Saitama Medical University /ID# 148015
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Jichi Medical University Hospital /ID# 159620
City
Shimotsuke-shi
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Juntendo University Hospital /ID# 148050
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
St.Luke's International Hospital /ID# 148041
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Toho University Ohashi Medical Center /ID# 148027
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
1538515
Country
Japan
Facility Name
Keio University Hospital /ID# 148057
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 148052
City
Shimonoseki-shi
State/Province
Yamaguchi
ZIP/Postal Code
752-0976
Country
Japan
Facility Name
National Hospital Organization Beppu Medical Center /ID# 161058
City
Beppu
ZIP/Postal Code
874 - 001
Country
Japan
Facility Name
NHO Chiba-East-Hospital /ID# 148035
City
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Sugimoto Rheumatology and Internal Medicine Clinic /ID# 148047
City
Fukui
ZIP/Postal Code
910-0068
Country
Japan
Facility Name
Shono Rheumatism Clinic /ID# 148046
City
Fukuoka
ZIP/Postal Code
814-0002
Country
Japan
Facility Name
Matsubara Mayflower Hospital /ID# 148033
City
Kato
ZIP/Postal Code
673-1462
Country
Japan
Facility Name
St. Mary's Hospital /ID# 148038
City
Kurume
ZIP/Postal Code
830-8543
Country
Japan
Facility Name
Kagawa University Hospital /ID# 148016
City
Kyoto
ZIP/Postal Code
615-8256
Country
Japan
Facility Name
Yu Family Clinic /ID# 148048
City
Miyagi
ZIP/Postal Code
981-0112
Country
Japan
Facility Name
Daido Hospital /ID# 160868
City
Nagoya
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Kondo Clinic for Ortho & Rheum /ID# 148032
City
Nagoya
ZIP/Postal Code
464-0071
Country
Japan
Facility Name
Shirahama Hamayu Hospital /ID# 148253
City
Nishimura
ZIP/Postal Code
649-2211
Country
Japan
Facility Name
Oribe Clinic of Rheumatology and Internal Medicine /ID# 156035
City
Oita
ZIP/Postal Code
870-0823
Country
Japan
Facility Name
Osaka City General Hospital /ID# 159617
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Sanuki Municipal Hospital /ID# 158842
City
Sanuki
ZIP/Postal Code
769-2321
Country
Japan
Facility Name
Sagawa Akira Rheumatology Clin /ID# 148043
City
Sapporo
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Sapporo City General Hospital /ID# 148037
City
Sapporo
ZIP/Postal Code
060-8604
Country
Japan
Facility Name
Hokkaido University Hospital /ID# 148262
City
Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Hokkaido Medical Center for Rheumatic Diseases /ID# 148259
City
Sapporo
ZIP/Postal Code
063-0811
Country
Japan
Facility Name
Azuma Rheumatology Clinic /ID# 161050
City
Sayama
ZIP/Postal Code
350-1305
Country
Japan
Facility Name
Hikarigaoka Spellman Hospital /ID# 148020
City
Sendai
ZIP/Postal Code
983-0833
Country
Japan
Facility Name
Takaoka Rheumatic Orthopedic Clinic /ID# 148022
City
Takaoka
ZIP/Postal Code
933-0874
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center /ID# 148040
City
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
National Hospital Organization Shimoshizu National Hospital /ID# 148258
City
Yotsukaido
ZIP/Postal Code
284-0003
Country
Japan
Facility Name
JSC Nat Scientific Med Res Ctr /ID# 143272
City
Astana
ZIP/Postal Code
010009
Country
Kazakhstan
Facility Name
Karaganda State Medical Univ /ID# 153431
City
Karaganda
ZIP/Postal Code
100008
Country
Kazakhstan
Facility Name
Semey State Medical University /ID# 152661
City
Semey
ZIP/Postal Code
071403
Country
Kazakhstan
Facility Name
Regional Clinical Hospital /ID# 147173
City
Shymkent
ZIP/Postal Code
160000
Country
Kazakhstan
Facility Name
LTD M+M Centers /ID# 143279
City
Adazi
ZIP/Postal Code
2164
Country
Latvia
Facility Name
Hosp Lithuanian Univ Health Sc /ID# 143582
City
Kaunas
State/Province
Kovno
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Klaipeda University Hospital /ID# 143583
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Vilnius University Hospital /ID# 143584
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Clinstile, S.A. de C.V. /ID# 143591
City
Cuauhtemoc
State/Province
Ciudad De Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 153562
City
Mexico City
State/Province
Ciudad De Mexico
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Invest y Biomed de Chihuahua /ID# 143595
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
RM Pharma Specialists, S.A de C.V /ID# 143593
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 143592
City
Mexico City
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 143589
City
Mexico City
ZIP/Postal Code
11650
Country
Mexico
Facility Name
Centro Reumatologico de Queret /ID# 149493
City
Queretaro
ZIP/Postal Code
76178
Country
Mexico
Facility Name
Waikato Hospital /ID# 143602
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Middlemore Clinical Trials /ID# 143600
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Porter Rheumatology Ltd /ID# 143601
City
Nelson
ZIP/Postal Code
7010
Country
New Zealand
Facility Name
Timaru Medical Specialists Ltd /ID# 143599
City
Timaru
ZIP/Postal Code
7910
Country
New Zealand
Facility Name
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 143606
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Centrum Medyczne AMED /ID# 143604
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01-518
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa /ID# 143608
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01-869
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia /ID# 143607
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Silmedic Sp z o.o /ID# 143605
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-282
Country
Poland
Facility Name
NZOZ Centrum Reumatologiczne /ID# 143603
City
Elblag
State/Province
Warminsko-mazurskie
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Medyczne Centrum Hetmanska /ID# 144726
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Instituto Portugues De Reumatologia /ID# 148313
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Ocidental, EPE /ID# 151009
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Centro Hospitalar De Vila Nova /ID# 143615
City
Vila Nova De Gaia
State/Province
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, EPE /ID# 143613
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar Baixo Vouga /ID# 153726
City
Porto
ZIP/Postal Code
4050-111
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao, EPE /ID# 153575
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Unidade Local De Saude Do Alto Minho /ID# 143611
City
Viana Do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Facility Name
Centro Hosp de Tondela-Viseu /ID# 143612
City
Viseu
ZIP/Postal Code
3504-509
Country
Portugal
Facility Name
Ponce School of Medicine /ID# 145657
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
GCM Medical Group /ID# 143618
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 143619
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Spitalul Clinic Dr. I. Cantacuzino /ID# 143622
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Spitalul Clinic Sf. Maria /ID# 143623
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic Sf. Maria /ID# 143625
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic Sf. Maria /ID# 143627
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic de Recuperare /ID# 143620
City
Iasi
ZIP/Postal Code
700656
Country
Romania
Facility Name
Ecomed SRL /ID# 143629
City
Oradea
ZIP/Postal Code
410028
Country
Romania
Facility Name
Family Outpatient clinic#4,LLC /ID# 151010
City
Korolev
State/Province
Moskva
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143641
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
LLC Medical Center /ID# 143647
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
LLC Novaya Klinika /ID# 143631
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Kazan State Medical University /ID# 143645
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Tver Regional Clinical Hosp. /ID# 143639
City
Tver
State/Province
Tverskaya Oblast
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Russian National Research Medi /ID# 143642
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Hos /ID# 143630
City
Orenburg
ZIP/Postal Code
460018
Country
Russian Federation
Facility Name
Republican Clin Hos n.a. Baran /ID# 143634
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Ryazan State Medical Universit /ID# 143646
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Samara Regional Clinical Hosp /ID# 150928
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Reg Clin Hosp n.a. Kuvatova G. /ID# 143632
City
UFA
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clin Hosp /ID# 143644
City
Ulyanovsk
ZIP/Postal Code
432018
Country
Russian Federation
Facility Name
Voronezh State Medical Univers /ID# 150926
City
Voronezh
ZIP/Postal Code
394036
Country
Russian Federation
Facility Name
Clinical Center Serbia /ID# 143649
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Serbia /ID# 143650
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Special Hospital for Rheuma /ID# 143648
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
MEDMAN s.r.o. /ID# 143661
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Reumatologická ambulancia Reum.hapi s.r.o. /ID# 143657
City
Nové Mesto Nad Váhom
ZIP/Postal Code
915 01
Country
Slovakia
Facility Name
REUMACENTRUM s.r.o. /ID# 143653
City
Partizanske
ZIP/Postal Code
958 01
Country
Slovakia
Facility Name
Slovak research center Team Member, Thermium s.r.o. /ID# 143663
City
Pieštany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
Slovak Research Center /ID# 143659
City
Puchov
ZIP/Postal Code
02001
Country
Slovakia
Facility Name
TIMMED spol. s r.o. /ID# 143664
City
Stará Lubovna
ZIP/Postal Code
06401
Country
Slovakia
Facility Name
Reumatologicka ambulancia, LER /ID# 143660
City
Topolcany
ZIP/Postal Code
955 01
Country
Slovakia
Facility Name
MEDEOS s.r.o. /ID# 143656
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
REUMA-GLOBAL, s.r.o. /ID# 143655
City
Trnava
ZIP/Postal Code
91701
Country
Slovakia
Facility Name
ALBAMED s.r.o. /ID# 143654
City
Zvolen
ZIP/Postal Code
960 01
Country
Slovakia
Facility Name
Reuma -MUDr. Maria Palasthyova /ID# 143662
City
Žiar nad Hronom
ZIP/Postal Code
965 01
Country
Slovakia
Facility Name
Univ Medical Ctr Ljubljana /ID# 143667
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Jakaranda Hosp, Emmed Research /ID# 143668
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0132
Country
South Africa
Facility Name
Jakaranda Hosp, Emmed Research /ID# 145976
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0132
Country
South Africa
Facility Name
Arthritis Clinical Research Tr /ID# 143670
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Winelands Medical Research Ctr /ID# 143669
City
Stellenbosch
State/Province
Western Cape
ZIP/Postal Code
7600
Country
South Africa
Facility Name
H. Un. Marques de Valdecilla /ID# 143671
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Comple Hosp Univ de A Coruna /ID# 143672
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron /ID# 143675
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clin Univ San Carlos /ID# 143674
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clinica Gaias /ID# 143673
City
Santiago de Compostela
ZIP/Postal Code
15702
Country
Spain
Facility Name
Hosp Nuestra Senora Esperanza /ID# 143677
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
HFR Fribourg - Hopital Canton /ID# 143700
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
China Medical University Hosp /ID# 143703
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan Univ Hosp /ID# 143702
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Dalin Tzu Chi General Hospital /ID# 153535
City
Dalin
ZIP/Postal Code
622
Country
Taiwan
Facility Name
Hopital Mongi Slim /ID# 152870
City
La Marsa
ZIP/Postal Code
2046
Country
Tunisia
Facility Name
Institut Mohamed Kassab /ID# 152869
City
Manouba
ZIP/Postal Code
2010
Country
Tunisia
Facility Name
Hopital Farhat Hached /ID# 152868
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
Charles Nicolle Univ Hosp /ID# 152866
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia
Facility Name
Hospital La Rabta /ID# 152867
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
Facility Name
Uludag Universitesi Ataturk Rehabilitasyon ve Uygulama Merkezi /ID# 143705
City
Osmangazi
State/Province
Bursa
ZIP/Postal Code
16080
Country
Turkey
Facility Name
Izmir Tepecik Training and Research Hospital /ID# 157863
City
Konak
State/Province
Izmir
ZIP/Postal Code
35180
Country
Turkey
Facility Name
Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143704
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Facility Name
Lviv Regional Clinical Hospita /ID# 154449
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143714
City
Vinnytsia
State/Province
Vinnytska Oblast
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Regional Clinical Hospital /ID# 152029
City
Ivano-frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
NSC-Strazhesko Ist Cardiology /ID# 152026
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
LLC Revmocentr /ID# 143710
City
Kyiv
ZIP/Postal Code
04070
Country
Ukraine
Facility Name
MNCE "Lviv City Clinical Hospital #4" /ID# 143711
City
Lviv
ZIP/Postal Code
79007
Country
Ukraine
Facility Name
Odessa National Medical Univ /ID# 143715
City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
Zaporizhzhia Regional Clinical /ID# 143712
City
Zaporizhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Leicester Royal Infirmary /ID# 143718
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Whipps Cross Univ Hospital /ID# 143721
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Western General Hospital /ID# 144431
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Chapel Allerton Hospital /ID# 143717
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Queen Alexandra Hospital /ID# 143722
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Southampton General Hospital /ID# 143716
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
32638504
Citation
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.
Results Reference
background
PubMed Identifier
36125701
Citation
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.
Results Reference
derived
PubMed Identifier
34897366
Citation
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.
Results Reference
derived
PubMed Identifier
34041702
Citation
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.
Results Reference
derived
PubMed Identifier
33313898
Citation
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.
Results Reference
derived
PubMed Identifier
33115760
Citation
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. Erratum In: Ann Rheum Dis. 2021 May;80(5):e83.
Results Reference
derived
PubMed Identifier
31610021
Citation
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.
Results Reference
derived
Links:
URL
https://www.rxabbvie.com/
Description
Related Info.
Learn more about this trial
A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
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