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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

Primary Purpose

Rheumatoid Arthritis (RA)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abatacept
Placebo for abatacept
Upadacitinib
Placebo for upadacitinib
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis (RA) focused on measuring Musculoskeletal Disease, Arthritis, Joint Disease, Anti-inflammatory agents, Antirheumatic agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA
  • Participants have been treated for ≥ 3 months prior to the screening visit 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 high-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening

Main 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 mL/minute/1.73 meter (m)^2; total white blood cell count < 2,500/ μL; absolute neutrophil count < 1,500/μL; platelet count < 100,000/μL; absolute lymphocyte count < 800/μL; and hemoglobin < 10 g/dL

Sites / Locations

  • SunValley Arthritis Center, Lt /ID# 154558
  • AZ Arthritis & Rheum Research /ID# 156539
  • AZ Arth & Rheum Res /ID# 167161
  • CHI St. Vincent Medical Group /ID# 154561
  • Saint Jude Heritage /ID# 158833
  • Kotha and Kotha /ID# 154573
  • Denver Arthritis Clinic /ID# 159195
  • Arthritis and Rheum Clin N. CO /ID# 155673
  • Scientia Medical Research /ID# 159189
  • Clinical Res of West FL, Inc. /ID# 154576
  • Advanced Clin Res of Orlando /ID# 154580
  • Gulf Region Clinical Res Inst /ID# 154597
  • W. Broward Rheum Assoc Inc. /ID# 158835
  • Lovelace Scientific Resources /ID# 154600
  • Jefrey D. Lieberman, MD, P.C. /ID# 157178
  • Advanced Clinical Research /ID# 154603
  • PMG Research of Christie Clini /ID# 154569
  • Bluegrass Community Research /ID# 154604
  • Four Rivers Clinical Research /ID# 154606
  • Ochsner Clinic Foundation /ID# 154585
  • The Center for Rheumatology & Bone Research /ID# 158723
  • West Michigan Rheumatology /ID# 154551
  • Advanced Rheumatology, PC /ID# 154589
  • Clinvest Research LLC /ID# 154554
  • Overlook Medical Center /ID# 154794
  • Atlantic Coast Research /ID# 155234
  • Ocean Rheumatology, PA /ID# 162980
  • Arthritis and Osteo Assoc /ID# 154560
  • The Center for Rheumatology /ID# 162979
  • NYU Langone Rheum Assoc /ID# 155236
  • NYU Langone Medical Center /ID# 158829
  • Physicians East, PA /ID# 154565
  • PMG Research of Salisbury /ID# 154605
  • PMG Research of Wilmington LLC /ID# 154584
  • Wake Forest Baptist Medical Center /ID# 154586
  • Oregon Health and Science University /ID# 163822
  • East Penn Rheumatology Assoc /ID# 159193
  • Altoona Ctr Clinical Res /ID# 154572
  • University of Pittsburgh MC /ID# 157434
  • West Tennessee Research Inst /ID# 158721
  • Adriana Pop-Moody MD Clinic PA /ID# 154607
  • P&I Clinical Research /ID# 159191
  • DM Clinical Research /ID# 158722
  • Care Access Research /ID# 158098
  • Aprillus Asistencia e Investig /ID# 159173
  • Ctr Privado Med Familiar /ID# 158814
  • Atencion Integral en Reuma /ID# 155696
  • Hospital General de Agudos /ID# 167117
  • Inst. de Rehab. Psicofisica /ID# 167768
  • Inst. Rheumatologic Strusberg /ID# 159021
  • Instituto Medico DAMIC /ID# 167770
  • DIM Clinica Privada /ID# 167769
  • Instituto CAICI SRL /ID# 159022
  • Rheumatology Research Unit /ID# 159174
  • The Queen Elizabeth Hospital /ID# 159175
  • Western Health Footscray Hospi /ID# 157968
  • CHU UCL Namur /ID# 157628
  • CEDOES-Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo LTDA /ID# 155228
  • Santa Casa de Belo Horizonte /ID# 154631
  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 154564
  • Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 154634
  • Hospital de Clinicas de Porto Alegre /ID# 161211
  • LMK Sevicos Medicos S/S /ID# 159176
  • CEMEC - Centro Multidisciplinar de Estudos Clínicos /ID# 154632
  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 159587
  • MHAT Trimontsium /ID# 155226
  • Diag Consult Ctr 17 Sofia EOOD /ID# 169298
  • UMHAT Sv. Ivan Rilski /ID# 155000
  • Medical Centre Synexus Sofia /ID# 201807
  • The Waterside Clinic /ID# 159178
  • Adachi Medicine Prof. Corp /ID# 158024
  • Institut de Rhum. de Montreal /ID# 155001
  • Groupe de Recherche en Maladies Osseuses /ID# 154601
  • Revmatologicky ustav Praha /ID# 154612
  • Medical Plus, s.r.o. /ID# 155230
  • Uniklinik Koln /ID# 156047
  • Praxis fuer Rheumatologie /ID# 156156
  • Rheumaforschungszentrum II /ID# 157177
  • Welcker, Planegg, DE /ID# 160185
  • University General Hospital of Heraklion "PA.G.N.I" /ID# 163916
  • Budai Irgalmasrendi Korhaz /ID# 154457
  • Obudai Egeszsegugyi Centrum Kft. /ID# 156159
  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 159183
  • Markhot Ferenc Oktatokorhaz es Rendelointezet /ID# 159689
  • MAV Korhaz ess Rendelointezet /ID# 154455
  • Our Lady's Hospital /ID# 161149
  • Barzilai Medical Center /ID# 161685
  • The Lady Davis Carmel MC /ID# 161686
  • Meir Medical Center /ID# 162774
  • Sheba Medical Center /ID# 163154
  • A.O. Univ. Ospedali Riuniti /ID# 161707
  • Istituto Clinico Humanitas /ID# 154999
  • AOU Citta della Salute Scienza /ID# 154577
  • Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 162252
  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 161172
  • ASST G. Pini /ID# 162223
  • SMG-SNU Boramae Medical Center /ID# 155788
  • The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 155231
  • Asan Medical Center /ID# 154639
  • D.Saulites-Kandevicas PP /ID# 154578
  • Riga East Clinical Univ Hosp /ID# 155024
  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 154579
  • Morales Vargas Centro de Investigacion S.C. /ID# 200800
  • Centro Integral en Reumatología S.A de C.V /ID# 204493
  • RM Pharma Specialists S.A de C.V /ID# 159588
  • Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 160126
  • Antonius Ziekenhuis /ID# 155737
  • Reade /ID# 161002
  • Spaarne Gasthuis /ID# 161003
  • Medisch Centrum Leeuwarden /ID# 156043
  • Timaru Medical Specialists Ltd /ID# 159184
  • Wellington Hospital (Capital and Coast District Health Board) /ID# 154591
  • Salve Medica Sp. z o.o. S.K. /ID# 202473
  • Malopolskie Centrum Kliniczne /ID# 157180
  • Centrum Medyczne AMED Warszawa Targowek /ID# 159589
  • Gabinet Internistyczno Reum. /ID# 157433
  • ClinicMed Daniluk, Nowak Sp.j. /ID# 202998
  • Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 202472
  • Medyczne Centrum Hetmanska /ID# 155746
  • Centrum Med Amed Oddzial Lodzi /ID# 154458
  • Instituto Portugues De Reumatologia /ID# 155698
  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 200035
  • Hospital Garcia de Orta, E.P.E /ID# 164056
  • Centro Hospitalar Lisboa Norte, EPE /ID# 200037
  • Unidade Local De Saude Do Alto Minho /ID# 200036
  • Centro Hosp de Tondela-Viseu /ID# 155699
  • Dr. Ramon L. Ortega-Colon, MD /ID# 158097
  • GCM Medical Group /ID# 156158
  • Spitalul Clinic Dr. I. Cantacuzino /ID# 155893
  • Spitalul Clinic Sf. Maria /ID# 167245
  • Family Outpatient clinic#4 LLC /ID# 203524
  • LLC Medical Center /ID# 203523
  • Alliance Biomedical Ural Group /ID# 154609
  • State Budget Healthcare Instit /ID# 154593
  • Nort-Western State Medical Uni /ID# 154610
  • Novamed,spol.s.r.o. /ID# 157928
  • Univerzitna Nemocnica Bratislava /ID# 161143
  • Narodny ustav reumatickych chorob Piestany /ID# 156864
  • Hospital Universitario Reina S /ID# 155701
  • Hospital General Univ de Elche /ID# 158825
  • Hospital Universitario La Paz /ID# 163636
  • Corp Sanitaria Parc Tauli /ID# 163634
  • Complejo Hospitalario /ID# 155700
  • Hospital Infanta Luisa /ID# 154641
  • Skanes Universitetssjukhus /ID# 165133
  • Akademiskt specialistcentrum Centrum for reumatologi /ID# 156046
  • Sahlgrenska University Hosp /ID# 162775
  • Vastmanlands Sjukhus /ID# 159186
  • Hopitaux Universitaires de Geneve /ID# 159083
  • Kantonsspital St. Gallen /ID# 155232
  • University Hospital of Basel /ID# 160860
  • HFR Fribourg - Hopital Canton /ID# 160970
  • Hacettepe University Medical Faculty /ID# 167995
  • Ankara Univ Medical Faculty /ID# 162691
  • Akdeniz University Faculty /ID# 163153
  • Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 169479
  • Whipps Cross Univ Hospital /ID# 205985
  • Ninewells Hospital /ID# 156050
  • Altnagelvin Area Hospital /ID# 156540
  • Lancashire Care NHS Foundation /ID# 156042
  • Royal Cornwall Hospital /ID# 157785

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Abatacept

Upadacitinib 15 mg

Arm Description

500 mg (for body weight <60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight >100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20

One 15 mg tablet taken once per day by mouth for 24 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Non-inferiority)
The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.

Secondary Outcome Measures

Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)
The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)
The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS 28 score less than 2.6 indicates clinical remission.

Full Information

First Posted
March 20, 2017
Last Updated
June 28, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03086343
Brief Title
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
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
June 13, 2019 (Actual)
Study Completion Date
June 6, 2023 (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 study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.
Detailed Description
This is a Phase 3 multicenter study with 2 periods. Period 1 was a 24-week, randomized, double-blind, parallel-group, active-controlled period designed to compare the safety and efficacy of upadacitinib 15 mg and abatacept for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid RA who had an inadequate response to or intolerance to bDMARD therapy and were currently on a stable dose of csDMARD(s) and had never received abatacept. Period 2 is an open-label, long-term extension study to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg once a day (QD) in participants with RA who had completed Period 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)
Keywords
Musculoskeletal Disease, Arthritis, Joint Disease, Anti-inflammatory agents, Antirheumatic agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
613 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abatacept
Arm Type
Active Comparator
Arm Description
500 mg (for body weight <60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight >100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20
Arm Title
Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
One 15 mg tablet taken once per day by mouth for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Abatacept
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo for abatacept
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494
Intervention Description
15 mg extended release tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for upadacitinib
Intervention Description
Film-coated tablet
Primary Outcome Measure Information:
Title
Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Non-inferiority)
Description
The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)
Description
The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)
Description
The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS 28 score less than 2.6 indicates clinical remission.
Time Frame
At Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA Participants have been treated for ≥ 3 months prior to the screening visit 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 high-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening Main 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 mL/minute/1.73 meter (m)^2; total white blood cell count < 2,500/ μL; absolute neutrophil count < 1,500/μL; platelet count < 100,000/μL; absolute lymphocyte count < 800/μL; and hemoglobin < 10 g/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
SunValley Arthritis Center, Lt /ID# 154558
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
AZ Arthritis & Rheum Research /ID# 156539
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
AZ Arth & Rheum Res /ID# 167161
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
CHI St. Vincent Medical Group /ID# 154561
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913-6999
Country
United States
Facility Name
Saint Jude Heritage /ID# 158833
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Kotha and Kotha /ID# 154573
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Denver Arthritis Clinic /ID# 159195
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Arthritis and Rheum Clin N. CO /ID# 155673
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Scientia Medical Research /ID# 159189
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Clinical Res of West FL, Inc. /ID# 154576
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Advanced Clin Res of Orlando /ID# 154580
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761-4547
Country
United States
Facility Name
Gulf Region Clinical Res Inst /ID# 154597
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
W. Broward Rheum Assoc Inc. /ID# 158835
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Lovelace Scientific Resources /ID# 154600
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Jefrey D. Lieberman, MD, P.C. /ID# 157178
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Advanced Clinical Research /ID# 154603
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
PMG Research of Christie Clini /ID# 154569
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Bluegrass Community Research /ID# 154604
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40515
Country
United States
Facility Name
Four Rivers Clinical Research /ID# 154606
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Ochsner Clinic Foundation /ID# 154585
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836-6455
Country
United States
Facility Name
The Center for Rheumatology & Bone Research /ID# 158723
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
West Michigan Rheumatology /ID# 154551
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Advanced Rheumatology, PC /ID# 154589
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Clinvest Research LLC /ID# 154554
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810-2607
Country
United States
Facility Name
Overlook Medical Center /ID# 154794
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901-3561
Country
United States
Facility Name
Atlantic Coast Research /ID# 155234
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Ocean Rheumatology, PA /ID# 162980
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Arthritis and Osteo Assoc /ID# 154560
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
The Center for Rheumatology /ID# 162979
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
NYU Langone Rheum Assoc /ID# 155236
City
Lake Success
State/Province
New York
ZIP/Postal Code
11554
Country
United States
Facility Name
NYU Langone Medical Center /ID# 158829
City
New York
State/Province
New York
ZIP/Postal Code
10016-6402
Country
United States
Facility Name
Physicians East, PA /ID# 154565
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
PMG Research of Salisbury /ID# 154605
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
PMG Research of Wilmington LLC /ID# 154584
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Wake Forest Baptist Medical Center /ID# 154586
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
Oregon Health and Science University /ID# 163822
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
East Penn Rheumatology Assoc /ID# 159193
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Ctr Clinical Res /ID# 154572
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
University of Pittsburgh MC /ID# 157434
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
West Tennessee Research Inst /ID# 158721
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Adriana Pop-Moody MD Clinic PA /ID# 154607
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
P&I Clinical Research /ID# 159191
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904-3132
Country
United States
Facility Name
DM Clinical Research /ID# 158722
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Care Access Research /ID# 158098
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124-1377
Country
United States
Facility Name
Aprillus Asistencia e Investig /ID# 159173
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1046
Country
Argentina
Facility Name
Ctr Privado Med Familiar /ID# 158814
City
Buenos Aires
ZIP/Postal Code
1417
Country
Argentina
Facility Name
Atencion Integral en Reuma /ID# 155696
City
Buenos Aires
ZIP/Postal Code
1426AAL
Country
Argentina
Facility Name
Hospital General de Agudos /ID# 167117
City
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Inst. de Rehab. Psicofisica /ID# 167768
City
Caba
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Inst. Rheumatologic Strusberg /ID# 159021
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Instituto Medico DAMIC /ID# 167770
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
DIM Clinica Privada /ID# 167769
City
Ramos Mejía
ZIP/Postal Code
1704
Country
Argentina
Facility Name
Instituto CAICI SRL /ID# 159022
City
Rosario, Santa FE
ZIP/Postal Code
S2000PBJ
Country
Argentina
Facility Name
Rheumatology Research Unit /ID# 159174
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
The Queen Elizabeth Hospital /ID# 159175
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Western Health Footscray Hospi /ID# 157968
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
CHU UCL Namur /ID# 157628
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
CEDOES-Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo LTDA /ID# 155228
City
Vitoria
State/Province
Espirito Santo
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
Santa Casa de Belo Horizonte /ID# 154631
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 154564
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 154634
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 161211
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
LMK Sevicos Medicos S/S /ID# 159176
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos /ID# 154632
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09190-510
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 159587
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
MHAT Trimontsium /ID# 155226
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Diag Consult Ctr 17 Sofia EOOD /ID# 169298
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
UMHAT Sv. Ivan Rilski /ID# 155000
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Medical Centre Synexus Sofia /ID# 201807
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
The Waterside Clinic /ID# 159178
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
Adachi Medicine Prof. Corp /ID# 158024
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Institut de Rhum. de Montreal /ID# 155001
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Groupe de Recherche en Maladies Osseuses /ID# 154601
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Revmatologicky ustav Praha /ID# 154612
City
Prague 2
State/Province
Praha 2
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Medical Plus, s.r.o. /ID# 155230
City
Uherské Hradište
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Uniklinik Koln /ID# 156047
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Praxis fuer Rheumatologie /ID# 156156
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Rheumaforschungszentrum II /ID# 157177
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Welcker, Planegg, DE /ID# 160185
City
Planegg
ZIP/Postal Code
82152
Country
Germany
Facility Name
University General Hospital of Heraklion "PA.G.N.I" /ID# 163916
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Budai Irgalmasrendi Korhaz /ID# 154457
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft. /ID# 156159
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 159183
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Markhot Ferenc Oktatokorhaz es Rendelointezet /ID# 159689
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
MAV Korhaz ess Rendelointezet /ID# 154455
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Our Lady's Hospital /ID# 161149
City
Manorhamilton
Country
Ireland
Facility Name
Barzilai Medical Center /ID# 161685
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
The Lady Davis Carmel MC /ID# 161686
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Meir Medical Center /ID# 162774
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Sheba Medical Center /ID# 163154
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
A.O. Univ. Ospedali Riuniti /ID# 161707
City
Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Facility Name
Istituto Clinico Humanitas /ID# 154999
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
AOU Citta della Salute Scienza /ID# 154577
City
Turin
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 162252
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 161172
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
ASST G. Pini /ID# 162223
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
SMG-SNU Boramae Medical Center /ID# 155788
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 155231
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
07345
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 154639
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
D.Saulites-Kandevicas PP /ID# 154578
City
Liepaja
ZIP/Postal Code
3401
Country
Latvia
Facility Name
Riga East Clinical Univ Hosp /ID# 155024
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 154579
City
Mexico City
State/Province
Ciudad De Mexico
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Morales Vargas Centro de Investigacion S.C. /ID# 200800
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Centro Integral en Reumatología S.A de C.V /ID# 204493
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
RM Pharma Specialists S.A de C.V /ID# 159588
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 160126
City
Mexico City
ZIP/Postal Code
11650
Country
Mexico
Facility Name
Antonius Ziekenhuis /ID# 155737
City
Sneek
State/Province
Fryslan
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
Reade /ID# 161002
City
Amsterdam
ZIP/Postal Code
1056 AB
Country
Netherlands
Facility Name
Spaarne Gasthuis /ID# 161003
City
Haarlem
ZIP/Postal Code
2035 RC
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden /ID# 156043
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Timaru Medical Specialists Ltd /ID# 159184
City
Timaru
ZIP/Postal Code
7910
Country
New Zealand
Facility Name
Wellington Hospital (Capital and Coast District Health Board) /ID# 154591
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Salve Medica Sp. z o.o. S.K. /ID# 202473
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
91-211
Country
Poland
Facility Name
Malopolskie Centrum Kliniczne /ID# 157180
City
Cracow
State/Province
Malopolskie
ZIP/Postal Code
30-149
Country
Poland
Facility Name
Centrum Medyczne AMED Warszawa Targowek /ID# 159589
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Gabinet Internistyczno Reum. /ID# 157433
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-099
Country
Poland
Facility Name
ClinicMed Daniluk, Nowak Sp.j. /ID# 202998
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 202472
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Medyczne Centrum Hetmanska /ID# 155746
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Centrum Med Amed Oddzial Lodzi /ID# 154458
City
Lodz
ZIP/Postal Code
91-363
Country
Poland
Facility Name
Instituto Portugues De Reumatologia /ID# 155698
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Ocidental, EPE /ID# 200035
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Hospital Garcia de Orta, E.P.E /ID# 164056
City
Almada
State/Province
Setubal
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, EPE /ID# 200037
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Unidade Local De Saude Do Alto Minho /ID# 200036
City
Viana Do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Facility Name
Centro Hosp de Tondela-Viseu /ID# 155699
City
Viseu
ZIP/Postal Code
3504-509
Country
Portugal
Facility Name
Dr. Ramon L. Ortega-Colon, MD /ID# 158097
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
GCM Medical Group /ID# 156158
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Spitalul Clinic Dr. I. Cantacuzino /ID# 155893
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Spitalul Clinic Sf. Maria /ID# 167245
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Family Outpatient clinic#4 LLC /ID# 203524
City
Korolev
State/Province
Moskva
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
LLC Medical Center /ID# 203523
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Alliance Biomedical Ural Group /ID# 154609
City
Izhevsk
State/Province
Udmurtskaya Respublika
ZIP/Postal Code
426061
Country
Russian Federation
Facility Name
State Budget Healthcare Instit /ID# 154593
City
Moscow
ZIP/Postal Code
121374
Country
Russian Federation
Facility Name
Nort-Western State Medical Uni /ID# 154610
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Novamed,spol.s.r.o. /ID# 157928
City
Banska Bystrica
ZIP/Postal Code
97405
Country
Slovakia
Facility Name
Univerzitna Nemocnica Bratislava /ID# 161143
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Narodny ustav reumatickych chorob Piestany /ID# 156864
City
Pieštany
ZIP/Postal Code
921 12
Country
Slovakia
Facility Name
Hospital Universitario Reina S /ID# 155701
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital General Univ de Elche /ID# 158825
City
Elche
ZIP/Postal Code
03202
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 163636
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Corp Sanitaria Parc Tauli /ID# 163634
City
Sabadell, Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Complejo Hospitalario /ID# 155700
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Infanta Luisa /ID# 154641
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Skanes Universitetssjukhus /ID# 165133
City
Malmö
State/Province
Skane Lan
ZIP/Postal Code
214 28
Country
Sweden
Facility Name
Akademiskt specialistcentrum Centrum for reumatologi /ID# 156046
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
113 65
Country
Sweden
Facility Name
Sahlgrenska University Hosp /ID# 162775
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Vastmanlands Sjukhus /ID# 159186
City
Vasteras
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Hopitaux Universitaires de Geneve /ID# 159083
City
Genève
State/Province
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Kantonsspital St. Gallen /ID# 155232
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
University Hospital of Basel /ID# 160860
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
HFR Fribourg - Hopital Canton /ID# 160970
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
Hacettepe University Medical Faculty /ID# 167995
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Univ Medical Faculty /ID# 162691
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Akdeniz University Faculty /ID# 163153
City
Antalya
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 169479
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Whipps Cross Univ Hospital /ID# 205985
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Ninewells Hospital /ID# 156050
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital /ID# 156540
City
Londonderry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
Facility Name
Lancashire Care NHS Foundation /ID# 156042
City
Preston
Country
United Kingdom
Facility Name
Royal Cornwall Hospital /ID# 157785
City
Truro
ZIP/Postal Code
TR1 3LJ
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 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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
33053283
Citation
Rubbert-Roth A, Enejosa J, Pangan AL, Haraoui B, Rischmueller M, Khan N, Zhang Y, Martin N, Xavier RM. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. N Engl J Med. 2020 Oct 15;383(16):1511-1521. doi: 10.1056/NEJMoa2008250.
Results Reference
background
PubMed Identifier
35751108
Citation
Bergman M, Tundia N, Martin N, Suboticki JL, Patel J, Goldschmidt D, Song Y, Wright GC. Patient-reported outcomes of upadacitinib versus abatacept in patients with rheumatoid arthritis and an inadequate response to biologic disease-modifying antirheumatic drugs: 12- and 24-week results of a phase 3 trial. Arthritis Res Ther. 2022 Jun 24;24(1):155. doi: 10.1186/s13075-022-02813-x. Erratum In: Arthritis Res Ther. 2022 Nov 3;24(1):248.
Results Reference
derived

Learn more about this trial

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

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