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A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs ( SELECT-CHOICE ) (SELECT-CHOICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03086343
Recruitment Status : Active, not recruiting
First Posted : March 22, 2017
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The comparison of safety and efficacy of upadacitinib versus abatacept in participants with rheumatoid arthritis on a stable background conventional synthetic Disease Modifying Anti-Rheumatic Drug (csDMARD) who have an inadequate response or intolerance to biologic DMARDs.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Drug: Upadacitinib matching placebo Drug: Abatacept matching placebo Drug: Upadacitinib Drug: Abatacept Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : June 7, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arm Intervention/treatment
Active Comparator: Abatacept followed by upadacitinib
Intravenous (IV) infusion of abatacept at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20 followed by upadacitinib starting at week 24 up to 5 years.
Drug: Upadacitinib matching placebo
Oral tablet

Drug: Abatacept
IV infusion

Experimental: Upadacitinib
Once daily for 24 weeks during Period 1 and up to 5 years during Period 2.
Drug: Abatacept matching placebo
IV infusion

Drug: Upadacitinib
Oral Tablet
Other Name: ABT-494




Primary Outcome Measures :
  1. Change in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) (non-inferiority) [ Time Frame: At week 12 ]
    The Disease Activity Score (DAS)28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.


Secondary Outcome Measures :
  1. Proportion of participants achieving Disease Activity Score (DAS) 28 based Clinical Remission (CR) [ Time Frame: At week 12 ]
    Proportion of participants achieving Clinical Remission (CR) as defined by a clinical response Disease Activity Score (DAS)28 C-Reactive Protein (CRP) less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than or equal to 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates CR.

  2. Change in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) (superiority) [ Time Frame: At week 12 ]
    The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (RA) for >= 3 months.
  • Participants have been treated for >= 3 months with >= 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration and have never received abatacept prior to the first dose of study drug.
  • Participants have been receiving csDMARD therapy >= 3 months and on a stable dose for >= 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
  • Meets the following criteria: >= 6 swollen joints (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits and hsCRP >= 3 mg/L at Screening .

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib and filgotinib).
  • Prior exposure to abatacept
  • History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted
  • Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug: serum aspartate transaminase > 2 × upper limit of normal (ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease formula < 40 milli liter (mL)/minute/1.73 meter (m)^2; total white blood cell count < 2,500/micro liter (μL); absolute neutrophil count < 1,500/μL; platelet count < 100,000/μL; absolute lymphocyte count < 800/μL; and hemoglobin < 10 g/ deciliter (dL).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086343


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Locations
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United States, Arizona
SunValley Arthritis Center, Lt /ID# 154558
Peoria, Arizona, United States, 85381
AZ Arthritis & Rheum Research /ID# 156539
Sun City, Arizona, United States, 85351
AZ Arth & Rheum Res /ID# 167161
Tucson, Arizona, United States, 85704
United States, Arkansas
CHI St. Vincent Medical Group /ID# 154561
Hot Springs, Arkansas, United States, 71913-6999
United States, California
Saint Jude Heritage /ID# 158833
Fullerton, California, United States, 92835
Kotha and Kotha /ID# 154573
La Mesa, California, United States, 91942
United States, Colorado
Denver Arthritis Clinic /ID# 159195
Denver, Colorado, United States, 80230
Arthritis and Rheum Clin N. CO /ID# 155673
Fort Collins, Colorado, United States, 80528
Scientia Medical Research /ID# 159189
Lakewood, Colorado, United States, 80228
United States, Florida
Clinical Res of West FL, Inc. /ID# 154576
Clearwater, Florida, United States, 33765
Advanced Clin Res of Orlando /ID# 154580
Ocoee, Florida, United States, 34761-4547
Gulf Region Clinical Res Inst /ID# 154597
Pensacola, Florida, United States, 32514
W. Broward Rheum Assoc Inc. /ID# 158835
Tamarac, Florida, United States, 33321
Lovelace Scientific Resources /ID# 154600
Venice, Florida, United States, 34292
United States, Georgia
Jefrey D. Lieberman, MD, P.C. /ID# 157178
Decatur, Georgia, United States, 30033
United States, Idaho
Advanced Clinical Research /ID# 154603
Meridian, Idaho, United States, 83642
United States, Illinois
PMG Research of Christie Clini /ID# 154569
Champaign, Illinois, United States, 61820
United States, Kentucky
Bluegrass Community Research /ID# 154604
Lexington, Kentucky, United States, 40515
Four Rivers Clinical Research /ID# 154606
Paducah, Kentucky, United States, 42003
United States, Louisiana
Ochsner Clinic Foundation /ID# 154585
New Orleans, Louisiana, United States, 70121
United States, Maryland
The Center for Rheumatology & /ID# 158723
Wheaton, Maryland, United States, 20902
United States, Michigan
West Michigan Rheumatology /ID# 154551
Grand Rapids, Michigan, United States, 49546
Advanced Rheumatology, PC /ID# 154589
Lansing, Michigan, United States, 48910
United States, Missouri
Clinvest Research LLC /ID# 154554
Springfield, Missouri, United States, 65810-2607
United States, New Jersey
Overlook Medical Center /ID# 154794
Summit, New Jersey, United States, 07901-3561
Atlantic Coast Research /ID# 155234
Toms River, New Jersey, United States, 08755
Ocean Rheumatology, PA /ID# 162980
Toms River, New Jersey, United States, 08755
United States, New Mexico
Arthritis and Osteo Assoc /ID# 154560
Las Cruces, New Mexico, United States, 88011
United States, New York
The Center for Rheumatology /ID# 162979
Albany, New York, United States, 12206
NYU Langone Rheum Assoc /ID# 155236
Lake Success, New York, United States, 11554
NYU Langone Medical Center /ID# 158829
New York, New York, United States, 10016-6402
United States, North Carolina
Physicians East, PA /ID# 154565
Greenville, North Carolina, United States, 27834
PMG Research of Salisbury /ID# 154605
Salisbury, North Carolina, United States, 28144
PMG Research of Wilmington LLC /ID# 154584
Wilmington, North Carolina, United States, 28401
Wake Forest Baptist Medical Ce /ID# 154586
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Oregon Health and Science University /ID# 163822
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
East Penn Rheumatology Assoc /ID# 159193
Bethlehem, Pennsylvania, United States, 18015
Altoona Ctr Clinical Res /ID# 154572
Duncansville, Pennsylvania, United States, 16635
University of Pittsburgh MC /ID# 157434
Pittsburgh, Pennsylvania, United States, 15260
United States, Tennessee
West Tennessee Research Inst /ID# 158721
Jackson, Tennessee, United States, 38305
United States, Texas
Adriana Pop-Moody MD Clinic PA /ID# 154607
Corpus Christi, Texas, United States, 78404
P&I Clinical Research /ID# 159191
Lufkin, Texas, United States, 75904-3132
DM Clinical Research /ID# 158722
Tomball, Texas, United States, 77375
United States, Utah
Care Access Research /ID# 158098
Salt Lake City, Utah, United States, 84124-1377
Argentina
Aprillus Asistencia e Investig /ID# 159173
Capital Federal, Buenos Aires, Argentina, 1046
Ctr Privado Med Familiar /ID# 158814
Buenos Aires, Argentina, 1417
Atencion Integral en Reuma /ID# 155696
Buenos Aires, Argentina, 1426AAL
Hospital General de Agudos /ID# 167117
Buenos Aires, Argentina, C1221ADC
Inst. de Rehab. Psicofisica /ID# 167768
Caba, Argentina, 1428
Inst. Rheumatologic Strusberg /ID# 159021
Cordoba, Argentina, 5000
Instituto Medico DAMIC /ID# 167770
Cordoba, Argentina, X5003DCE
DIM Clinica Privada /ID# 167769
Ramos Mejía, Argentina, 1704
Instituto CAICI SRL /ID# 159022
Rosario, Santa FE, Argentina, S2000PBJ
Australia, Queensland
Rheumatology Research Unit /ID# 159174
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
The Queen Elizabeth Hospital /ID# 159175
Woodville, South Australia, Australia, 5011
Australia, Victoria
Western Health Footscray Hospi /ID# 157968
Footscray, Victoria, Australia, 3011
Belgium
CHU UCL Namur /ID# 157628
Namur, Belgium, 5000
Brazil
CEDOES-Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo LTDA /ID# 155228
Vitoria, Espirito Santo, Brazil, 29055-450
Santa Casa de Belo Horizonte /ID# 154631
Belo Horizonte, Minas Gerais, Brazil, 30150-221
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 154564
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 154634
Curitiba, Parana, Brazil, 80030-110
Hospital de Clinicas de Porto Alegre /ID# 161211
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
LMK Sevicos Medicos S/S /ID# 159176
Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
CEMEC - Centro Multidisciplinar de Estudos Clínicos /ID# 154632
Santo André, Sao Paulo, Brazil, 09190-510
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 159587
São Paulo, Sao Paulo, Brazil, 04266-010
Bulgaria
MHAT Trimontsium /ID# 155226
Plovdiv, Bulgaria, 4000
Diag Consult Ctr 17 Sofia EOOD /ID# 169298
Sofia, Bulgaria, 1505
UMHAT Sv. Ivan Rilski /ID# 155000
Sofia, Bulgaria, 1612
Medical Centre Synexus Sofia /ID# 201807
Sofia, Bulgaria, 1784
Canada, Ontario
The Waterside Clinic /ID# 159178
Barrie, Ontario, Canada, L4M 6L2
Adachi Medicine Prof. Corp /ID# 158024
Hamilton, Ontario, Canada, L8N 1Y2
Canada, Quebec
Institut de Rhum. de Montreal /ID# 155001
Montreal, Quebec, Canada, H2L 1S6
Groupe de Recherche en Maladies Osseuses /ID# 154601
Sainte-foy, Quebec, Canada, G1V 3M7
Czechia
Revmatologicky ustav Praha /ID# 154612
Prague 2, Praha 2, Czechia, 128 00
Medical Plus, s.r.o. /ID# 155230
Uherské Hradište, Czechia, 686 01
Germany
Uniklinik Koln /ID# 156047
Köln, Nordrhein-Westfalen, Germany, 50937
Praxis fuer Rheumatologie /ID# 156156
Berlin, Germany, 12163
Rheumaforschungszentrum II /ID# 157177
Hamburg, Germany, 20095
Welcker, Planegg, DE /ID# 160185
Planegg, Germany, 82152
Greece
University General Hospital of Heraklion "PA.G.N.I" /ID# 163916
Heraklion, Greece, 71110
Hungary
Budai Irgalmasrendi Korhaz /ID# 154457
Budapest, Hungary, 1023
Revita Reumatologiai Rendelo /ID# 158820
Budapest, Hungary, 1027
Obudai Egeszsegugyi Centrum Kft. /ID# 156159
Budapest, Hungary, 1036
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 159183
Debrecen, Hungary, 4031
Markhot Ferenc Oktatokorhaz es Rendelointezet /ID# 159689
Eger, Hungary, 3300
MAV Korhaz ess Rendelointezet /ID# 154455
Szolnok, Hungary, 5000
Ireland
Our Lady's Hospital /ID# 161149
Manorhamilton, Ireland
Israel
Barzilai Medical Center /ID# 161685
Ashkelon, Israel, 78278
The Lady Davis Carmel MC /ID# 161686
Haifa, Israel, 3436212
Meir Medical Center /ID# 162774
Kfar Saba, Israel, 44281
Sheba Medical Center /ID# 163154
Ramat Gan, Israel, 5262100
Italy
A.O. Univ. Ospedali Riuniti /ID# 161707
Ancona, Marche, Italy, 60126
Istituto Clinico Humanitas /ID# 154999
Rozzano, Milano, Italy, 20089
AOU Citta della Salute Scienza /ID# 154577
Turin, Piemonte, Italy, 10126
Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 162252
Rome, Roma, Italy, 00168
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 161172
Catania, Italy, 95123
ASST G. Pini /ID# 162223
Milan, Italy, 20122
Korea, Republic of
SMG-SNU Boramae Medical Center /ID# 155788
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07061
The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 155231
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07345
Asan Medical Center /ID# 154639
Seoul, Korea, Republic of, 05505
Latvia
D.Saulites-Kandevicas PP /ID# 154578
Liepaja, Latvia, 3401
Riga East Clinical Univ Hosp /ID# 155024
Riga, Latvia, 1038
Mexico
Morales Vargas Centro de Investigación S.C /ID# 200800
León de los Aldama, Guanajuato, Mexico, 37000
Centro Integral en Reumatología S.A de C.V /ID# 204493
Guadalajara, Jalisco, Mexico, 44160
RM Pharma Specialists, S.A de C.V /ID# 159588
Mexico City, Mexico, 03100
Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 160126
Mexico City, Mexico, 11650
(CINTRE) Centro de Investigac. /ID# 154579
Mexico City, Mexico, 11850
Netherlands
Antonius Ziekenhuis /ID# 155737
Sneek, Fryslan, Netherlands, 8601 ZK
Reade /ID# 161002
Amsterdam, Netherlands, 1056 AB
Spaarne Gasthuis /ID# 161003
Haarlem, Netherlands, 2035 RC
Medisch Centrum Leeuwarden /ID# 156043
Leeuwarden, Netherlands, 8934 AD
New Zealand
Timaru Medical Specialists Ltd /ID# 159184
Timaru, New Zealand, 7910
Wellington Hospital (Capital and Coast District Health Board) /ID# 154591
Wellington, New Zealand, 6021
Poland
Salve Medica Sp. z o.o. S.K. /ID# 202473
Lodz, Lodzkie, Poland, 91-211
Malopolskie Centrum Kliniczne /ID# 157180
Cracow, Malopolskie, Poland, 30-149
Centrum Medyczne AMED Warszawa Targowek /ID# 159589
Warszawa, Mazowieckie, Poland, 03-291
Gabinet Internistyczno Reum. /ID# 157433
Białystok, Podlaskie, Poland, 15-099
ClinicMed Daniluk, Nowak Sp.j. /ID# 202998
Białystok, Podlaskie, Poland, 15-879
Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 202472
Gdynia, Pomorskie, Poland, 81-537
Medyczne Centrum Hetmanska /ID# 155746
Poznań, Wielkopolskie, Poland, 60-218
Centrum Med Amed Oddzial Lodzi /ID# 154458
Lodz, Poland, 91-363
Portugal
Instituto Portugues De Reumatologia /ID# 155698
Lisbon, Lisboa, Portugal, 1050-034
Centro Hospitalar Lisboa Ocidental, EPE /ID# 200035
Lisbon, Lisboa, Portugal, 1349-019
Hospital Garcia de Orta, E.P.E /ID# 164056
Almada, Setubal, Portugal, 2805-267
Centro Hospitalar Lisboa Norte, EPE /ID# 200037
Lisboa, Portugal, 1649-035
Unidade Local De Saude Do Alto Minho /ID# 200036
Viana Do Castelo, Portugal, 4901-858
Centro Hosp de Tondela-Viseu /ID# 155699
Viseu, Portugal, 3504 - 509
Puerto Rico
Dr. Ramon L. Ortega-Colon, MD /ID# 158097
Carolina, Puerto Rico, 00983
GCM Medical Group /ID# 156158
San Juan, Puerto Rico, 00909
Romania
Spitalul Clinic Dr. I. Cantacuzino /ID# 155893
Bucharest, Bucuresti, Romania, 020475
Spitalul Clinic Sf. Maria /ID# 167245
Bucuresti, Romania, 011172
Russian Federation
Family Outpatient clinic#4,LLC /ID# 203524
Korolev, Moskva, Russian Federation, 141060
LLC Medical Center /ID# 203523
Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630061
Alliance Biomedical Ural Group /ID# 154609
Izhevsk, Udmurtskaya Respublika, Russian Federation, 426061
State Budget Healthcare Instit /ID# 154593
Moscow, Russian Federation, 121374
Nort-Western State Medical Uni /ID# 154610
St. Petersburg, Russian Federation, 191015
Slovakia
Novamed,spol.s.r.o. /ID# 157928
Banska Bystrica, Slovakia, 97405
Univerzitna Nemocnica Bratislava /ID# 161143
Bratislava, Slovakia, 826 06
Narodny ustav reumatickych chorob Piestany /ID# 156864
Pieštany, Slovakia, 921 01
Spain
Hospital Universitario Reina S /ID# 155701
Cordoba, Spain, 14004
Hospital General Univ de Elche /ID# 158825
Elche, Spain, 03202
Hospital Universitario La Paz /ID# 163636
Madrid, Spain, 28046
Corp Sanitaria Parc Tauli /ID# 163634
Sabadell, Barcelona, Spain, 08208
Complejo Hospitalario /ID# 155700
Santiago de Compostela, Spain, 15706
Hospital Infanta Luisa /ID# 154641
Sevilla, Spain, 41010
Sweden
Skanes Universitetssjukhus /ID# 165133
Malmö, Skane Lan, Sweden, 214 28
Akademiskt specialistcentrum Centrum for reumatologi /ID# 156046
Stockholm, Stockholms Lan, Sweden, 113 65
Sahlgrenska University Hosp /ID# 162775
Goteborg, Sweden, 413 45
Vastmanlands Sjukhus /ID# 159186
Vasteras, Sweden, 72189
Switzerland
Hopitaux Universitaires de Geneve /ID# 159083
Genève, Geneve, Switzerland, 1205
Kantonsspital St. Gallen /ID# 155232
St. Gallen, Sankt Gallen, Switzerland, 9007
University Hospital of Basel /ID# 160860
Basel, Switzerland, 4031
HFR Fribourg - Hopital Canton /ID# 160970
Fribourg, Switzerland, 1708
Turkey
Hacettepe University Medical Faculty /ID# 167995
Ankara, Turkey, 06100
Ankara Univ Medical Faculty /ID# 162691
Ankara, Turkey, 6100
Akdeniz University Faculty /ID# 163153
Antalya, Turkey, 06100
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 169479
Istanbul, Turkey, 34147
United Kingdom
Whipps Cross Univ Hospital /ID# 205985
London, London, City Of, United Kingdom, E11 1NR
Ninewells Hospital /ID# 156050
Dundee, United Kingdom, DD1 9SY
Altnagelvin Area Hospital /ID# 156540
Londonderry, United Kingdom, BT47 6SB
Lancashire Care NHS Foundation /ID# 156042
Preston, United Kingdom
Royal Cornwall Hospital /ID# 157785
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03086343     History of Changes
Other Study ID Numbers: M15-925
2016-000933-37 ( EudraCT Number )
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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 and 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Keywords provided by AbbVie:
Musculoskeletal Disease
Arthritis
Joint Disease
Anti-inflammatory agents
Antirheumatic agents
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis
Arthritis, Rheumatoid
Abatacept
Upadacitinib
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action