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A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)

Primary Purpose

Rheumatoid Arthritis

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

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, Upadacitinib, ABT-494

Eligibility Criteria

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

Inclusion Criteria:

  • Adult male or female, at least 18 years old.
  • Diagnosis of Rheumatoid Arthritis (RA) for greater than or equal to 3 months.
  • Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: Methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
  • Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
  • Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods.

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
  • Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.

Sites / Locations

  • AZ Arthritis and Rheum Assoc /ID# 148651
  • SunValley Arthritis Center, Lt /ID# 140452
  • AZ Arthritis and Rheum Researc /ID# 138500
  • AZ Arthritis and Rheum Researc /ID# 139286
  • AZ Arthritis & Rheuma Research /ID# 138598
  • Arizona Research Center, Inc. /ID# 140448
  • University of Arizona Cancer Center - North Campus /ID# 140451
  • Covina Arthritis Clinic /ID# 139881
  • T. Joseph Raoof, MD, Inc. /ID# 140964
  • Allergy and Rheum Med Clin /ID# 146082
  • Pacific Arthritis Ctr Med Grp /ID# 138744
  • Robin K. Dore MD, Inc /ID# 138688
  • Inland Rheum Clin Trials Inc. /ID# 138853
  • Denver Arthritis Clinic /ID# 139876
  • Clinical Res of West FL, Inc. /ID# 138854
  • Ctr Arthritis & Rheumatic Dise /ID# 141696
  • Medallion Clinical Research Institute, LLC /ID# 140074
  • Suncoast Clinical Research /ID# 138633
  • Omega Research Consultants /ID# 139877
  • Arthritis Center, Inc. /ID# 141363
  • Institute of Arthritis Res /ID# 138548
  • OrthoIllinois /ID# 139695
  • Clinical Investigation Special /ID# 139696
  • Springfield Clinic /ID# 138602
  • Deerbrook Medical Associates /ID# 139694
  • Indiana Univ School of Med /ID# 140077
  • Bluegrass Community Research /ID# 138295
  • Four Rivers Clinical Research /ID# 141134
  • MMP Women's Health /ID# 141542
  • The Center for Rheumatology & /ID# 139203
  • Mansfield Health Center /ID# 141357
  • Advanced Rheumatology, PC /ID# 140071
  • Justus J. Fiechtner, MD, PC /ID# 138697
  • Physician Res. Collaboration /ID# 138533
  • Westroads Clinical Research /ID# 138304
  • The Center for Rheumatology /ID# 138746
  • PMG Research of Salisbury /ID# 141023
  • PMG Research of Wilmington LLC /ID# 140951
  • Cincinnati Rheumatic Disease Study Group, Inc. /ID# 138868
  • Arthritis Assoc of NW Ohio /ID# 140953
  • Health Research Oklahoma /ID# 138535
  • Altoona Ctr Clinical Res /ID# 138741
  • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 138689
  • Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 141021
  • Tekton Research, Inc. /ID# 141428
  • Trinity Universal Res Assoc /ID# 149271
  • Arth and Osteo Clin Brazo Valley /ID# 147809
  • Metroplex Clinical Research /ID# 138698
  • Baylor College of Medicine /ID# 138682
  • Houston Institute for Clin Res /ID# 138716
  • Arthritis Consultants, P.A. /ID# 141138
  • Trinity Universal Research Association /ID# 148649
  • Accurate Clinical Management /ID# 139338
  • Arthritis & Osteoporosis Clinic /ID# 138703
  • Western Washington Arthritis C /ID# 138728
  • Arthritis Northwest, PLLC /ID# 138539
  • Aurora Rheumatology and Immunotherapy Center /ID# 139306
  • Mautalen Salud e Investigacion /ID# 141419
  • Inst. Rheumatologic Strusberg /ID# 145648
  • Coffs Clinical Trials /ID# 138747
  • Optimus Clinical Research Pty. /ID# 138769
  • Emeritus Research /ID# 138773
  • Barwon Rheumatology /ID# 138772
  • Rheuma Zentrum Favoriten GmbH /ID# 138787
  • Wilhelminenspital der Stadt Wien /ID# 138788
  • Rhumaconsult SPRL /ID# 138813
  • UZ Gent /ID# 138806
  • AZ Sint Lucas /ID# 141338
  • University Clinical Centre of the Republic of Srpska /ID# 138819
  • University Clinical Centre of the Republic of Srpska /ID# 140372
  • Diag Consult Ctr 17 Sofia EOOD /ID# 141006
  • Diagnostic Consultative Center /ID# 138882
  • Manitoba Clinic /ID# 139086
  • Eastern Health /ID# 140431
  • Groupe de Recherche en Maladies Osseuses /ID# 138906
  • Dr. Latha Naik /ID# 139089
  • Klinicki bolnicki centar Rijeka /ID# 138649
  • Klinicka bolnica Sveti Duh /ID# 152812
  • Medical Center Kuna-Peric /ID# 140365
  • Poliklinika Bonifarm /ID# 141415
  • L.K.N. Arthrocentrum, s.r.o /ID# 141340
  • Revmatologie, s.r.o. /ID# 138899
  • Artroscan s.r.o. /ID# 138833
  • Nemocnice Slany /ID# 141112
  • PV-MEDICAL s.r.o. /ID# 138913
  • Center of Clinical and Basic Research /ID# 141116
  • Paernu Hospital /ID# 138961
  • East Tallinn Central Hospital /ID# 140618
  • Helsinki Univ Central Hospital /ID# 140381
  • Kiljava Medical Research /ID# 139260
  • South Karelia Central Hospital /ID# 139973
  • Hopital Saint Joseph /ID# 149188
  • CHRU Tours - Hopital Trousseau /ID# 138969
  • Uniklinik Koln /ID# 139084
  • Charité Universitätsmedizin Campus Mitte /ID# 139052
  • Immanuel-Krankenhaus /ID# 139059
  • Asklepios Klinik Altona /ID# 140466
  • Welcker, Planegg, DE /ID# 140467
  • University General Hospital of Heraklion "PA.G.N.I" /ID# 139115
  • Prince of Wales Hospital /ID# 139314
  • Revita Reumatologiai Rendelo /ID# 140761
  • Fejer Megyei Szent Gyorgy Korh /ID# 138554
  • St Vincent's University Hosp /ID# 138562
  • Universita di Catanzaro Magna Graecia /ID# 139316
  • JSC Nat Scientific Med Res Ctr /ID# 140575
  • Inha University Hospital /ID# 149310
  • Ajou University Hospital /ID# 149311
  • Chonnam National University Hospital /ID# 138651
  • Hanyang University Seoul Hospi /ID# 138655
  • Cath Univ Seoul St Mary's Hosp /ID# 138652
  • Daegu Catholic University Med /ID# 139249
  • Chungnam National University Hospital /ID# 138653
  • Seoul National University Hospital /ID# 138659
  • Asan Medical Center /ID# 140579
  • LTD M+M Centers /ID# 138818
  • Klaipeda University Hospital /ID# 141416
  • Vilnius University Hospital /ID# 141348
  • Centro Peninsular de Investigación Clínica SCP /ID# 148160
  • Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 138841
  • Porter Rheumatology Ltd /ID# 138347
  • NZOZ Nasz Lekarz /ID# 138374
  • McBk Sc /Id# 138360
  • Osteo-Medic spolka cywilna /ID# 138371
  • NZOZ Centrum Reumatologiczne /ID# 138353
  • Rheuma Medicus /ID# 138372
  • Instituto Portugues De Reumatologia /ID# 148315
  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 140594
  • School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139328
  • Spitalul Clinic Judetean de Urgenta /ID# 138407
  • Spitalul Municipal Ploiesti /ID# 138405
  • Spitalul Clinic Judetean de Ur /ID# 138393
  • LLC Novaya Klinika /ID# 139269
  • Kazan State Medical University /ID# 138413
  • Republican Clin Hos n.a. Baran /ID# 139273
  • Samara Regional Clinical Hosp /ID# 148642
  • Ulyanovsk Regional Clin Hosp /ID# 139279
  • Voronezh State Medical Univers /ID# 148431
  • Yaroslavi State Medical Univer /ID# 139908
  • ARTROMAC n.o. /ID# 138428
  • Nemocnica Kosice Saca, a.s. /ID# 138918
  • Slovak research center Team Member, Thermium s.r.o. /ID# 139924
  • Narodny ustav reumatickych chorob Piestany /ID# 138427
  • REUMA-GLOBAL, s.r.o. /ID# 139912
  • St. Augustine's Medical Centre /ID# 141352
  • Arthritis Clinical Research Tr /ID# 138945
  • Winelands Medical Research Ctr /ID# 138944
  • Hospital Regional de Malaga /ID# 138975
  • Hospital General Univ de Elche /ID# 138991
  • Hospital Clin Univ San Carlos /ID# 138993
  • Hosp Nuestra Senora Esperanza /ID# 138997
  • HFR Fribourg - Hopital Canton /ID# 139155
  • China Medical University Hosp /ID# 139232
  • National Cheng Kung University Hospital /ID# 140868
  • National Taiwan Univ Hosp /ID# 141443
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 140869
  • Far Eastern Memorial Hospital /ID# 140871
  • Taipei Veterans General Hosp /ID# 139234
  • Ankara Numune Training and Res /ID# 139237
  • LLC Revmocentr /ID# 139872
  • MNCE "Lviv City Clinical Hospital #4" /ID# 139873
  • Odessa National Medical Univ /ID# 139179
  • Leicester Royal Infirmary /ID# 139184
  • Whipps Cross Univ Hospital /ID# 139523
  • The Royal Free Hospital /ID# 139191
  • Western General Hospital /ID# 139524
  • Southampton General Hospital /ID# 139169
  • Warrington + Halton Hosp NHS /ID# 139195

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Upadacitinib 15 mg

Upadacitinib 30 mg

Placebo / Upadacitinib 15 mg

Placebo / Upadacitinib 30 mg

Arm Description

Period 1: Participants receive upadacitinib 15 mg once daily for 12 weeks. Period 2: Participants continue to receive upadacitinib 15 mg once daily for an additional 248 weeks.

Period 1: Participants receive upadacitinib 30 mg once daily for 12 weeks. Period 2: Participants continue to receive upadacitinib 30 mg once daily for an additional 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.

Period 1: Participants receive placebo once daily for 12 weeks. Period 2: Participants receive upadacitinib 15 mg once daily for 248 weeks.

Period 1: Participants receive placebo once daily for 12 weeks. Period 2: Participants receive upadacitinib 30 mg once daily for 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.

Outcomes

Primary Outcome Measures

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
The primary endpoint for United States (US)/Food and Drug Administration (FDA) 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).
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 12. 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), 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 or equal to 3.2 indicates low disease activity.

Secondary Outcome Measures

Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12
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), 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
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 Summary (PCS) Score at Week 12
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 summary 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 Clinical Remission Based on DAS28 (CRP) at Week 12
Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6. 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), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score ≤ 10. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
Change From Baseline in Duration of Morning Stiffness at Week 12
Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days.
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a five point Likert scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response 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 With an American College of Rheumatology 70% (ACR70) Response at Week 12
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 American College of Rheumatology 20% (ACR20) Response at Week 1
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).

Full Information

First Posted
December 11, 2015
Last Updated
March 17, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02675426
Brief Title
A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone
Acronym
SELECT-NEXT
Official Title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2015 (Actual)
Primary Completion Date
April 21, 2017 (Actual)
Study Completion Date
March 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 primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.
Detailed Description
This Phase 3 multicenter study includes two periods. Period 1 is a 12-week, randomized, double-blind, parallel-group, placebo-controlled period designed to compare the safety and efficacy of upadacitinib 30 mg once daily and upadacitinib 15 mg once daily versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis (RA) who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs. Period 2 is a 248-week blinded long-term extension period to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 30 mg once daily and upadacitinib 15 mg once daily in participants who completed Period 1. Participants were to be randomized in a 2:2:1:1 ratio using interactive response technology (IRT) to receive double-blind study drug in one of the following treatment groups: Group 1: Upadacitinib 30 mg QD in Period 1 → Upadacitinib 30 mg QD in Period 2 Group 2: Upadacitinib 15 mg QD in Period 1 → Upadacitinib 15 mg QD in Period 2 Group 3: Placebo in Period 1 → Upadacitinib 30 mg QD in Period 2 Group 4: Placebo in Period 1 → Upadacitinib 15 mg QD in Period 2 Randomization was stratified by prior exposure to biological disease-modifying anti-rheumatic drug (bDMARD) (yes/no) and geographic region. Following Protocol Amendment 6.0 approval in December 2019, all participants still on study received open-label upadacitinib 15 mg QD, including those on upadacitinib 30 mg QD, with the earliest switch occurring at the Week 168 visit.

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, Upadacitinib, ABT-494

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
Period 1: Participants receive upadacitinib 15 mg once daily for 12 weeks. Period 2: Participants continue to receive upadacitinib 15 mg once daily for an additional 248 weeks.
Arm Title
Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
Period 1: Participants receive upadacitinib 30 mg once daily for 12 weeks. Period 2: Participants continue to receive upadacitinib 30 mg once daily for an additional 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.
Arm Title
Placebo / Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
Period 1: Participants receive placebo once daily for 12 weeks. Period 2: Participants receive upadacitinib 15 mg once daily for 248 weeks.
Arm Title
Placebo / Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
Period 1: Participants receive placebo once daily for 12 weeks. Period 2: Participants receive upadacitinib 30 mg once daily for 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 20% (ACR20) Response at Week 12
Description
The primary endpoint for United States (US)/Food and Drug Administration (FDA) 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
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
Description
The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 12. 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), 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 or equal to 3.2 indicates low disease activity.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12
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), 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 and Week 12
Title
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
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 and Week 12
Title
Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary (PCS) Score at Week 12
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 summary 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 and Week 12
Title
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12
Description
Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6. 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), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Time Frame
Week 12
Title
Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
Description
Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score ≤ 10. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
Time Frame
Week 12
Title
Change From Baseline in Duration of Morning Stiffness at Week 12
Description
Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days.
Time Frame
Baseline and Week 12
Title
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12
Description
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a five point Likert scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.
Time Frame
Baseline and week 12
Title
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
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 American College of Rheumatology 70% (ACR70) Response at Week 12
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 American College of Rheumatology 20% (ACR20) Response at Week 1
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 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male or female, at least 18 years old. Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months. Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits. Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods. Exclusion Criteria: Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted. Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
AZ Arthritis and Rheum Assoc /ID# 148651
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
SunValley Arthritis Center, Lt /ID# 140452
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
AZ Arthritis and Rheum Researc /ID# 138500
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
AZ Arthritis and Rheum Researc /ID# 139286
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
AZ Arthritis & Rheuma Research /ID# 138598
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arizona Research Center, Inc. /ID# 140448
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053-4061
Country
United States
Facility Name
University of Arizona Cancer Center - North Campus /ID# 140451
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719-1478
Country
United States
Facility Name
Covina Arthritis Clinic /ID# 139881
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
T. Joseph Raoof, MD, Inc. /ID# 140964
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Allergy and Rheum Med Clin /ID# 146082
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pacific Arthritis Ctr Med Grp /ID# 138744
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Robin K. Dore MD, Inc /ID# 138688
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Inland Rheum Clin Trials Inc. /ID# 138853
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Denver Arthritis Clinic /ID# 139876
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Clinical Res of West FL, Inc. /ID# 138854
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Ctr Arthritis & Rheumatic Dise /ID# 141696
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Medallion Clinical Research Institute, LLC /ID# 140074
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Suncoast Clinical Research /ID# 138633
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Omega Research Consultants /ID# 139877
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Arthritis Center, Inc. /ID# 141363
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Institute of Arthritis Res /ID# 138548
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
OrthoIllinois /ID# 139695
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114-4937
Country
United States
Facility Name
Clinical Investigation Special /ID# 139696
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Springfield Clinic /ID# 138602
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702-3749
Country
United States
Facility Name
Deerbrook Medical Associates /ID# 139694
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Indiana Univ School of Med /ID# 140077
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Bluegrass Community Research /ID# 138295
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40515
Country
United States
Facility Name
Four Rivers Clinical Research /ID# 141134
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
MMP Women's Health /ID# 141542
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
The Center for Rheumatology & /ID# 139203
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Mansfield Health Center /ID# 141357
City
Mansfield
State/Province
Massachusetts
ZIP/Postal Code
02048
Country
United States
Facility Name
Advanced Rheumatology, PC /ID# 140071
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Justus J. Fiechtner, MD, PC /ID# 138697
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Physician Res. Collaboration /ID# 138533
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Westroads Clinical Research /ID# 138304
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
The Center for Rheumatology /ID# 138746
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
PMG Research of Salisbury /ID# 141023
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
PMG Research of Wilmington LLC /ID# 140951
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Cincinnati Rheumatic Disease Study Group, Inc. /ID# 138868
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242-4468
Country
United States
Facility Name
Arthritis Assoc of NW Ohio /ID# 140953
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Health Research Oklahoma /ID# 138535
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103-2400
Country
United States
Facility Name
Altoona Ctr Clinical Res /ID# 138741
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 138689
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486-7887
Country
United States
Facility Name
Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 141021
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075-6213
Country
United States
Facility Name
Tekton Research, Inc. /ID# 141428
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Trinity Universal Res Assoc /ID# 149271
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Arth and Osteo Clin Brazo Valley /ID# 147809
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Metroplex Clinical Research /ID# 138698
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor College of Medicine /ID# 138682
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Houston Institute for Clin Res /ID# 138716
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Arthritis Consultants, P.A. /ID# 141138
City
Killeen
State/Province
Texas
ZIP/Postal Code
76549
Country
United States
Facility Name
Trinity Universal Research Association /ID# 148649
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-5283
Country
United States
Facility Name
Accurate Clinical Management /ID# 139338
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic /ID# 138703
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Western Washington Arthritis C /ID# 138728
City
Bothell
State/Province
Washington
ZIP/Postal Code
98021
Country
United States
Facility Name
Arthritis Northwest, PLLC /ID# 138539
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Aurora Rheumatology and Immunotherapy Center /ID# 139306
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
Mautalen Salud e Investigacion /ID# 141419
City
Buenos Aires
ZIP/Postal Code
1128
Country
Argentina
Facility Name
Inst. Rheumatologic Strusberg /ID# 145648
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Coffs Clinical Trials /ID# 138747
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Optimus Clinical Research Pty. /ID# 138769
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Emeritus Research /ID# 138773
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Barwon Rheumatology /ID# 138772
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Rheuma Zentrum Favoriten GmbH /ID# 138787
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Facility Name
Wilhelminenspital der Stadt Wien /ID# 138788
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Rhumaconsult SPRL /ID# 138813
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ Gent /ID# 138806
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Sint Lucas /ID# 141338
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 138819
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# 140372
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Diag Consult Ctr 17 Sofia EOOD /ID# 141006
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
Diagnostic Consultative Center /ID# 138882
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Manitoba Clinic /ID# 139086
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A IM3
Country
Canada
Facility Name
Eastern Health /ID# 140431
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Groupe de Recherche en Maladies Osseuses /ID# 138906
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Dr. Latha Naik /ID# 139089
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
Klinicki bolnicki centar Rijeka /ID# 138649
City
Rijeka
State/Province
Primorsko-goranska Zupanija
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Klinicka bolnica Sveti Duh /ID# 152812
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Medical Center Kuna-Peric /ID# 140365
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Poliklinika Bonifarm /ID# 141415
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
L.K.N. Arthrocentrum, s.r.o /ID# 141340
City
Hlučín
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
748 01
Country
Czechia
Facility Name
Revmatologie, s.r.o. /ID# 138899
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Artroscan s.r.o. /ID# 138833
City
Ostrava
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
Nemocnice Slany /ID# 141112
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
PV-MEDICAL s.r.o. /ID# 138913
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Center of Clinical and Basic Research /ID# 141116
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
10128
Country
Estonia
Facility Name
Paernu Hospital /ID# 138961
City
Pärnu
ZIP/Postal Code
80010
Country
Estonia
Facility Name
East Tallinn Central Hospital /ID# 140618
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Helsinki Univ Central Hospital /ID# 140381
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Kiljava Medical Research /ID# 139260
City
Hyvinkaa
ZIP/Postal Code
05800
Country
Finland
Facility Name
South Karelia Central Hospital /ID# 139973
City
Lappeenranta
ZIP/Postal Code
53130
Country
Finland
Facility Name
Hopital Saint Joseph /ID# 149188
City
Marseille CEDEX 08
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13285
Country
France
Facility Name
CHRU Tours - Hopital Trousseau /ID# 138969
City
Chambray Les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Uniklinik Koln /ID# 139084
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Charité Universitätsmedizin Campus Mitte /ID# 139052
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Immanuel-Krankenhaus /ID# 139059
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Asklepios Klinik Altona /ID# 140466
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Welcker, Planegg, DE /ID# 140467
City
Planegg
ZIP/Postal Code
82152
Country
Germany
Facility Name
University General Hospital of Heraklion "PA.G.N.I" /ID# 139115
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Prince of Wales Hospital /ID# 139314
City
Sha Tin
Country
Hong Kong
Facility Name
Revita Reumatologiai Rendelo /ID# 140761
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korh /ID# 138554
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
St Vincent's University Hosp /ID# 138562
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Universita di Catanzaro Magna Graecia /ID# 139316
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
JSC Nat Scientific Med Res Ctr /ID# 140575
City
Astana
ZIP/Postal Code
010009
Country
Kazakhstan
Facility Name
Inha University Hospital /ID# 149310
City
Incheon
State/Province
Gwang Yeogsi
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Ajou University Hospital /ID# 149311
City
Suwon-si
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital /ID# 138651
City
Gwangju
State/Province
Jeonranamdo
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospi /ID# 138655
City
Seoul
State/Province
Seongdong-gu
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Cath Univ Seoul St Mary's Hosp /ID# 138652
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Daegu Catholic University Med /ID# 139249
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital /ID# 138653
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 138659
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 140579
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
LTD M+M Centers /ID# 138818
City
Adazi
ZIP/Postal Code
2164
Country
Latvia
Facility Name
Klaipeda University Hospital /ID# 141416
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Vilnius University Hospital /ID# 141348
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Centro Peninsular de Investigación Clínica SCP /ID# 148160
City
Colonia Centro
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 138841
City
Mexico City
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Porter Rheumatology Ltd /ID# 138347
City
Nelson
ZIP/Postal Code
7010
Country
New Zealand
Facility Name
NZOZ Nasz Lekarz /ID# 138374
City
Toruń
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
McBk Sc /Id# 138360
City
Grodzisk Mazowiecki
State/Province
Mazowieckie
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Osteo-Medic spolka cywilna /ID# 138371
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
NZOZ Centrum Reumatologiczne /ID# 138353
City
Elblag
State/Province
Warminsko-mazurskie
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Rheuma Medicus /ID# 138372
City
Warsaw
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Instituto Portugues De Reumatologia /ID# 148315
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Ocidental, EPE /ID# 140594
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139328
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Spitalul Clinic Judetean de Urgenta /ID# 138407
City
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Spitalul Municipal Ploiesti /ID# 138405
City
Ploiesti
ZIP/Postal Code
100337
Country
Romania
Facility Name
Spitalul Clinic Judetean de Ur /ID# 138393
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
LLC Novaya Klinika /ID# 139269
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Kazan State Medical University /ID# 138413
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Republican Clin Hos n.a. Baran /ID# 139273
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Samara Regional Clinical Hosp /ID# 148642
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clin Hosp /ID# 139279
City
Ulyanovsk
ZIP/Postal Code
432018
Country
Russian Federation
Facility Name
Voronezh State Medical Univers /ID# 148431
City
Voronezh
ZIP/Postal Code
394036
Country
Russian Federation
Facility Name
Yaroslavi State Medical Univer /ID# 139908
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
Facility Name
ARTROMAC n.o. /ID# 138428
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Nemocnica Kosice Saca, a.s. /ID# 138918
City
Kosice
ZIP/Postal Code
040 15
Country
Slovakia
Facility Name
Slovak research center Team Member, Thermium s.r.o. /ID# 139924
City
Pieštany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
Narodny ustav reumatickych chorob Piestany /ID# 138427
City
Pieštany
ZIP/Postal Code
921 12
Country
Slovakia
Facility Name
REUMA-GLOBAL, s.r.o. /ID# 139912
City
Trnava
ZIP/Postal Code
91701
Country
Slovakia
Facility Name
St. Augustine's Medical Centre /ID# 141352
City
Berea
State/Province
Kwazulu-Natal
ZIP/Postal Code
NL 4001
Country
South Africa
Facility Name
Arthritis Clinical Research Tr /ID# 138945
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Winelands Medical Research Ctr /ID# 138944
City
Stellenbosch
State/Province
Western Cape
ZIP/Postal Code
7600
Country
South Africa
Facility Name
Hospital Regional de Malaga /ID# 138975
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Hospital General Univ de Elche /ID# 138991
City
Elche
ZIP/Postal Code
03202
Country
Spain
Facility Name
Hospital Clin Univ San Carlos /ID# 138993
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp Nuestra Senora Esperanza /ID# 138997
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
HFR Fribourg - Hopital Canton /ID# 139155
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
China Medical University Hosp /ID# 139232
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital /ID# 140868
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan Univ Hosp /ID# 141443
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 140869
City
Kaohsiung
ZIP/Postal Code
80708
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital /ID# 140871
City
New Taipei City
ZIP/Postal Code
22060
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 139234
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Ankara Numune Training and Res /ID# 139237
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
LLC Revmocentr /ID# 139872
City
Kyiv
ZIP/Postal Code
04070
Country
Ukraine
Facility Name
MNCE "Lviv City Clinical Hospital #4" /ID# 139873
City
Lviv
ZIP/Postal Code
79007
Country
Ukraine
Facility Name
Odessa National Medical Univ /ID# 139179
City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
Leicester Royal Infirmary /ID# 139184
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Whipps Cross Univ Hospital /ID# 139523
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
The Royal Free Hospital /ID# 139191
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Western General Hospital /ID# 139524
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Southampton General Hospital /ID# 139169
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Warrington + Halton Hosp NHS /ID# 139195
City
Warrington
ZIP/Postal Code
WA5 1LZ
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://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
29908669
Citation
Burmester GR, Kremer JM, Van den Bosch F, Kivitz A, Bessette L, Li Y, Zhou Y, Othman AA, Pangan AL, Camp HS. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
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
34636000
Citation
Bergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021 Dec;38(12):5649-5661. doi: 10.1007/s12325-021-01930-4. Epub 2021 Oct 12.
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
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
31815649
Citation
Strand V, Pope J, Tundia N, Friedman A, Camp HS, Pangan A, Ganguli A, Fuldeore M, Goldschmidt D, Schiff M. Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT. Arthritis Res Ther. 2019 Dec 9;21(1):272. doi: 10.1186/s13075-019-2037-1. Erratum In: Arthritis Res Ther. 2020 Jun 9;22(1):137.
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 Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

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