Back to resultsA Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Upadacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Musculoskeletal Disease, Arthritis, Joint Disease, Anti-inflammatory agents, Antirheumatic agents, ABT-494, upadacitinib
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of rheumatoid arthritis (RA) for≥ 3 months.
- Treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug.
- Participant has 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 both of 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.
- hsCRP ≥ 3mg/L at Screening Visit.
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]). Current diagnosis of secondary Sjogren's Syndrome is permitted.
Sites / Locations
- Rheum Assoc of North Alabama /ID# 145959
- AZ Arthritis and Rheum Assoc /ID# 148593
- AZ Arthritis and Rheum Researc /ID# 142816
- AZ Arthritis and Rheum Researc /ID# 146075
- AZ Arthritis and Rheum Researc /ID# 148592
- Arizona Research Center, Inc. /ID# 142741
- AZ Arthr & Rheum Research /ID# 155256
- AZ Arthritis & Rheum Research /ID# 156090
- NEA Baptist Clinic /ID# 149280
- Covina Arthritis Clinic /ID# 142794
- Rheumatology Ctr of San Diego /ID# 153576
- St. Joseph Heritage Healthcare /ID# 149273
- TriWest Research Associates- La Mesa /ID# 142792
- Arthritis & Osteo Medical Ctr /ID# 142770
- Valerius Med Grp & Res Ctr /ID# 142799
- Pacific Arthritis Ctr Med Grp /ID# 142783
- University of California, Los Angeles /ID# 148348
- Desert Medical Advances /ID# 142765
- Stanford University School of Med /ID# 142761
- Robin K. Dore MD, Inc /ID# 150908
- Inland Rheum Clin Trials Inc. /ID# 142787
- Medvin Clinical Research /ID# 142814
- Arthritis Assoc & Osteo Ctr /ID# 142809
- Denver Arthritis Clinic /ID# 142771
- New England Research Associates, LLC /ID# 142763
- Delaware Arthritis /ID# 142803
- Lakes Research, LLC /ID# 142755
- Medallion Clinical Research Institute, LLC /ID# 142740
- Omega Research Consultants /ID# 142780
- Millennium Research /ID# 142782
- Arthritis Research of Florida /ID# 142811
- Arthritis Center, Inc. /ID# 142822
- Advent Clinical Research /ID# 142817
- St. Anthony Comprehsve Res Ins /ID# 148349
- University of South Florida /ID# 145611
- BayCare Medical Group, Inc. /ID# 142747
- Lovelace Scientific Resources /ID# 142779
- Jefrey D. Lieberman, MD, P.C. /ID# 151713
- Marietta Rheumatology Assoc /ID# 151347
- St. Luke's Clinic - Rheumatolo /ID# 150923
- Institute of Arthritis Res /ID# 142810
- Advanced Clinical Research /ID# 153089
- Great Lakes Clinical Trials /ID# 148341
- Clinical Investigation Special /ID# 149270
- Springfield Clinic /ID# 142818
- Deerbrook Medical Associates /ID# 151712
- The Arthritis & Diabetes Clinic, Inc. /ID# 142793
- Vanguard Medical Research, LLC /ID# 153123
- MMP Women's Health /ID# 145612
- The Center for Rheumatology & /ID# 142742
- Mansfield Health Center /ID# 147628
- Clinical Pharmacology Study Gr /ID# 142744
- June DO, PC /ID# 142756
- North Mississippi Med Clinics /ID# 142781
- Clayton Medical Associates dba Saint Louis Rheumatology /ID# 142745
- Barbara Caciolo, MD /ID# 142749
- Westroads Clinical Research /ID# 142802
- Dartmouth-Hitchcock Medical Center /ID# 145958
- Atlantic Coast Research /ID# 148347
- Ocean Rheumatology, PA /ID# 142785
- The Center for Rheumatology /ID# 142784
- North Shore University Hospital /ID# 142772
- Buffalo Rheumatology /ID# 142766
- Joint & Muscle Research Instit /ID# 142797
- DJL Clinical Research, PLLC /ID# 142769
- Cape Fear Arthritis Care /ID# 148344
- Coastal Carolina Health Care /ID# 148351
- Shanahan Rheuma & Immuno /ID# 142812
- Trinity Health Med Arts Clinic /ID# 142754
- Cincinnati Rheumatic Disease Study Group, Inc. /ID# 142791
- STAT Research, Inc. /ID# 142821
- Health Research Oklahoma /ID# 142751
- Healthcare Research Consultant /ID# 142815
- East Penn Rheumatology Assoc /ID# 142790
- Clinical Research Ctr Reading /ID# 151714
- Columbia Arthritis Center /ID# 153728
- West Tennessee Research Inst /ID# 142739
- Arthritis Associates, PLLC /ID# 142774
- Arthritis Associates, PLLC /ID# 155462
- Dr. Ramesh Gupta /ID# 142767
- Tekton Research, Inc. /ID# 142805
- Diagnostic Group Integrated He /ID# 148340
- Arth and Osteo Clin Brazo Valley /ID# 148343
- Arthritis Care and Diagnostic /ID# 151344
- Metroplex Clinical Research /ID# 142758
- Rheumatic Disease Clin Res Ctr /ID# 150914
- Baylor College of Medicine /ID# 142753
- Rheumatology Clinic of Houston /ID# 150915
- Houston Institute for Clin Res /ID# 142768
- Pioneer Research Solutions, Inc. /ID# 151346
- Arthritis & Osteoporosis Assoc /ID# 147567
- P&I Clinical Research /ID# 151345
- SW Rheumatology Res. LLC /ID# 142813
- Trinity Universal Research Association /ID# 149278
- Arthritis & Osteo Ctr of S. TX /ID# 142773
- Arthritis Clinic of Central TX /ID# 148346
- DM Clinical Research /ID# 151007
- Arthritis & Osteoporosis Clinic /ID# 142760
- Western Washington Arthritis C /ID# 142776
- Arthritis Northwest, PLLC /ID# 150924
- The Vancouver Clinic, INC. PS /ID# 147946
- West Virginia Research Inst /ID# 153087
- Aurora Rheumatology and Immunotherapy Center /ID# 142820
- The Queen Elizabeth Hospital /ID# 142419
- Emeritus Research /ID# 142416
- Medizinische Universität Wien /ID# 142424
- Universitaetsklinik fuer Inner /ID# 142423
- Rheuma Zentrum Favoriten GmbH /ID# 142421
- Rheuma-Zentrum Wien-Oberlaa /ID# 142425
- Wilhelminenspital der Stadt Wien /ID# 142422
- Cliniques Universitaires Saint Luc /ID# 142426
- Rhumaconsult SPRL /ID# 151378
- UZ Gent /ID# 142429
- ReumaClinic Genk /ID# 142431
- AZ Damiaan /ID# 142427
- Ciads /Id# 142526
- Revmatologie MUDr. Klara Sirova /ID# 142536
- Medical Plus, s.r.o. /ID# 148345
- MediTrials /ID# 151777
- East Tallinn Central Hospital /ID# 142543
- Kiljava Medical Research /ID# 142546
- Paijat-Hame Central Hospital /ID# 149185
- CHR Orleans - Hopital de la Source /ID# 142557
- Hopital Universitaire Purpan /ID# 144697
- Hopital Saint Eloi /ID# 142552
- Centre Hospitalier Le Mans /ID# 145956
- CHU Bordeaux-Hopital Pellegrin /ID# 144700
- Centre Hospitalier Jean Rougie /ID# 142556
- Hopital Edouard Herriot /ID# 144698
- Rheumazentrum Ruhrgebiet /ID# 145600
- Uniklinik Koln /ID# 142563
- Charité Universitätsmedizin Campus Mitte /ID# 142559
- Rheumaforschungszentrum II /ID# 142560
- Schoen Klinikum Hamburg Eilbek /ID# 142566
- Asklepios Klinik Altona /ID# 142561
- LMU Klinikum der Universität München /ID# 142564
- MVZ Planegg /ID# 142565
- Knappschaftsklinikum Saar /ID# 142562
- General Hospital of Athens Laiko /ID# 142579
- Vital Medical Center Orvosi es /ID# 142586
- Revita Reumatologiai Rendelo /ID# 142590
- Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142587
- Bekes Megyei Pandy Kalman Korh /ID# 142588
- St Vincent's University Hosp /ID# 142593
- Tel Aviv Sourasky Medical Ctr /ID# 142597
- Bnai Zion Medical Center /ID# 151945
- The Lady Davis Carmel MC /ID# 142599
- Hanyang University Seoul Hospi /ID# 150883
- Inha University Hospital /ID# 150881
- Seoul National University Hospital /ID# 142622
- LTD M+M Centers /ID# 142624
- P. Stradins Clinical Univ Hosp /ID# 142623
- Arthritis Clinic Ltd /ID# 153560
- Timaru Medical Specialists Ltd /ID# 142657
- WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 142665
- Pratia MCM Krakow /ID# 142664
- Centrum Medyczne Pratia Warszawa /ID# 142667
- Centrum Medyczne AMED Warszawa Targowek /ID# 142663
- Centrum Medyczne Pratia Gdynia /ID# 142666
- Centro Hospitalar De Vila Nova /ID# 142670
- Centro Hospitalar Lisboa Norte, EPE /ID# 142668
- GCM Medical Group /ID# 142671
- Family Outpatient clinic#4,LLC /ID# 150910
- ARTROMAC n.o. /ID# 142692
- Nemocnica Kosice Saca, a.s. /ID# 142693
- Narodny ustav reumatickych chorob Piestany /ID# 142691
- H. Un. Marques de Valdecilla /ID# 142706
- Hospital Regional de Malaga /ID# 142707
- Comple Hosp Univ de A Coruna /ID# 142708
- Hospital Clin Univ San Carlos /ID# 142711
- Clinica Gaias /ID# 142709
- Hospital Universitario La Fe /ID# 142716
- Sahlgrenska University Hosp /ID# 142720
- Capio Movement Halmstad /ID# 148236
- Orebro Universitetssjukhuset /ID# 142718
- Vastmanlands Sjukhus /ID# 142721
- Universitaetsspital Basel /ID# 145610
- HFR Fribourg - Hopital Canton /ID# 142723
- Hacettepe University Medical Faculty /ID# 142729
- Ankara Ataturk Training & Res /ID# 142727
- Ondokuz mayis University Facul /ID# 142728
- Whipps Cross Univ Hospital /ID# 145957
- The Royal Free Hospital /ID# 142733
- Mid Essex Hospitals NHS Trust /ID# 148992
- Western General Hospital /ID# 142732
- West Suffolk Hospital /ID# 148993
- Queen Alexandra Hospital /ID# 142735
- Arrowe Park Hospital /ID# 148991
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Upadacitinib 15 mg
Upadacitinib 30 mg
Placebo / Upadacitnib 15 mg
Placebo / Upadacitnib 30 mg
Arm Description
Period 1: Participants receive upadacitinib 15 mg once daily for 24 weeks. Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
Period 1: Participants receive upadacitinib 30 mg once daily for 24 weeks. Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Period 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 15 mg once daily for 12 weeks. Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
Period 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 30 mg once daily for 12 weeks. Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
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 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 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 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline in DAS28 (CRP) indicates improvement in disease activity.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Percentage of Participants With 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
1. Study Identification
Unique Protocol Identification Number
NCT02706847
Brief Title
A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
Acronym
SELECT-BEYOND
Official Title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2016 (Actual)
Primary Completion Date
April 3, 2017 (Actual)
Study Completion Date
February 8, 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 study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.
The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.
Detailed Description
This study includes a 35-day screening period; a 24-week randomized, double-blind, parallel-group, placebo controlled treatment period (Period 1); a 236-week blinded long-term extension period (Period 2); and a 30-day follow-up period (call or visit).
Period 1 consists of a 12-week double-blind, placebo-controlled treatment phase plus a 12-week double-blind phase where all participants were to receive upadacitinib; at Week 12 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.
Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to one of four treatment groups:
Group 1: Upadacitinib 30 mg QD (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)
Group 2: Upadacitinib 15 mg QD (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)
Group 3: Placebo (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)
Group 4: Placebo (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)
Participants will continue stable dose of csDMARD therapy for the first 24 weeks of the study.
Participants who complete the Week 24 visit (end of Period 1) will enter the blinded long-term extension portion of the study, Period 2 and continue to receive the same dose of upadacitinib per original randomization assignment in a blinded manner. Starting at Week 24, at least 20% improvement in both swollen joint count (SJC) and tender joint count (TJC) compared to Baseline is required to remain on study drug. Starting at Week 24, initiation of or change in corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or adding or increasing doses in up to 2 csDMARDs (concomitant use of up to 2 csDMARDs except the combination of methotrexate and leflunomide) is allowed as per local label.
With the implementation of Protocol Amendment 4, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Musculoskeletal Disease, Arthritis, Joint Disease, Anti-inflammatory agents, Antirheumatic agents, ABT-494, upadacitinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
499 (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 24 weeks.
Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
Arm Title
Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
Period 1: Participants receive upadacitinib 30 mg once daily for 24 weeks.
Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Arm Title
Placebo / Upadacitnib 15 mg
Arm Type
Placebo Comparator
Arm Description
Period 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 15 mg once daily for 12 weeks.
Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
Arm Title
Placebo / Upadacitnib 30 mg
Arm Type
Placebo Comparator
Arm Description
Period 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 30 mg once daily for 12 weeks.
Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
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 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than 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 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline in DAS28 (CRP) indicates improvement in disease activity.
Time Frame
Baseline 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 Score (PCS) 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 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 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
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of rheumatoid arthritis (RA) for≥ 3 months.
Treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug.
Participant has 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 both of 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.
hsCRP ≥ 3mg/L at Screening Visit.
Exclusion Criteria:
Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]). Current diagnosis of secondary Sjogren's Syndrome is permitted.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Rheum Assoc of North Alabama /ID# 145959
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
AZ Arthritis and Rheum Assoc /ID# 148593
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
AZ Arthritis and Rheum Researc /ID# 142816
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
AZ Arthritis and Rheum Researc /ID# 146075
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
AZ Arthritis and Rheum Researc /ID# 148592
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
Arizona Research Center, Inc. /ID# 142741
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053-4061
Country
United States
Facility Name
AZ Arthr & Rheum Research /ID# 155256
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86305
Country
United States
Facility Name
AZ Arthritis & Rheum Research /ID# 156090
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
NEA Baptist Clinic /ID# 149280
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Covina Arthritis Clinic /ID# 142794
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Rheumatology Ctr of San Diego /ID# 153576
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
St. Joseph Heritage Healthcare /ID# 149273
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
TriWest Research Associates- La Mesa /ID# 142792
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Arthritis & Osteo Medical Ctr /ID# 142770
City
La Palma
State/Province
California
ZIP/Postal Code
90623-1728
Country
United States
Facility Name
Valerius Med Grp & Res Ctr /ID# 142799
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-5402
Country
United States
Facility Name
Pacific Arthritis Ctr Med Grp /ID# 142783
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
University of California, Los Angeles /ID# 148348
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Desert Medical Advances /ID# 142765
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Stanford University School of Med /ID# 142761
City
Stanford
State/Province
California
ZIP/Postal Code
94305-2200
Country
United States
Facility Name
Robin K. Dore MD, Inc /ID# 150908
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Inland Rheum Clin Trials Inc. /ID# 142787
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Medvin Clinical Research /ID# 142814
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Arthritis Assoc & Osteo Ctr /ID# 142809
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Denver Arthritis Clinic /ID# 142771
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
New England Research Associates, LLC /ID# 142763
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606-1827
Country
United States
Facility Name
Delaware Arthritis /ID# 142803
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Lakes Research, LLC /ID# 142755
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Medallion Clinical Research Institute, LLC /ID# 142740
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Omega Research Consultants /ID# 142780
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Millennium Research /ID# 142782
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Arthritis Research of Florida /ID# 142811
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684-2672
Country
United States
Facility Name
Arthritis Center, Inc. /ID# 142822
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Advent Clinical Research /ID# 142817
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
St. Anthony Comprehsve Res Ins /ID# 148349
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
University of South Florida /ID# 145611
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
BayCare Medical Group, Inc. /ID# 142747
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7101
Country
United States
Facility Name
Lovelace Scientific Resources /ID# 142779
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Jefrey D. Lieberman, MD, P.C. /ID# 151713
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Marietta Rheumatology Assoc /ID# 151347
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
St. Luke's Clinic - Rheumatolo /ID# 150923
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Institute of Arthritis Res /ID# 142810
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Advanced Clinical Research /ID# 153089
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Great Lakes Clinical Trials /ID# 148341
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Clinical Investigation Special /ID# 149270
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Springfield Clinic /ID# 142818
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702-3749
Country
United States
Facility Name
Deerbrook Medical Associates /ID# 151712
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
The Arthritis & Diabetes Clinic, Inc. /ID# 142793
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Vanguard Medical Research, LLC /ID# 153123
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71011
Country
United States
Facility Name
MMP Women's Health /ID# 145612
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
The Center for Rheumatology & /ID# 142742
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Mansfield Health Center /ID# 147628
City
Mansfield
State/Province
Massachusetts
ZIP/Postal Code
02048
Country
United States
Facility Name
Clinical Pharmacology Study Gr /ID# 142744
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
June DO, PC /ID# 142756
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
North Mississippi Med Clinics /ID# 142781
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Clayton Medical Associates dba Saint Louis Rheumatology /ID# 142745
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63119-3845
Country
United States
Facility Name
Barbara Caciolo, MD /ID# 142749
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63139-2338
Country
United States
Facility Name
Westroads Clinical Research /ID# 142802
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 145958
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Atlantic Coast Research /ID# 148347
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Ocean Rheumatology, PA /ID# 142785
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
The Center for Rheumatology /ID# 142784
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
North Shore University Hospital /ID# 142772
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Buffalo Rheumatology /ID# 142766
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Joint & Muscle Research Instit /ID# 142797
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
DJL Clinical Research, PLLC /ID# 142769
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210-8508
Country
United States
Facility Name
Cape Fear Arthritis Care /ID# 148344
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
Coastal Carolina Health Care /ID# 148351
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Shanahan Rheuma & Immuno /ID# 142812
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
Trinity Health Med Arts Clinic /ID# 142754
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Cincinnati Rheumatic Disease Study Group, Inc. /ID# 142791
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242-4468
Country
United States
Facility Name
STAT Research, Inc. /ID# 142821
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377-9464
Country
United States
Facility Name
Health Research Oklahoma /ID# 142751
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103-2400
Country
United States
Facility Name
Healthcare Research Consultant /ID# 142815
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
East Penn Rheumatology Assoc /ID# 142790
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Clinical Research Ctr Reading /ID# 151714
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Columbia Arthritis Center /ID# 153728
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
West Tennessee Research Inst /ID# 142739
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Arthritis Associates, PLLC /ID# 142774
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Arthritis Associates, PLLC /ID# 155462
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Dr. Ramesh Gupta /ID# 142767
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Tekton Research, Inc. /ID# 142805
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Diagnostic Group Integrated He /ID# 148340
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Arth and Osteo Clin Brazo Valley /ID# 148343
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Arthritis Care and Diagnostic /ID# 151344
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Metroplex Clinical Research /ID# 142758
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Rheumatic Disease Clin Res Ctr /ID# 150914
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Baylor College of Medicine /ID# 142753
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Rheumatology Clinic of Houston /ID# 150915
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Houston Institute for Clin Res /ID# 142768
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Pioneer Research Solutions, Inc. /ID# 151346
City
Houston
State/Province
Texas
ZIP/Postal Code
77098-5294
Country
United States
Facility Name
Arthritis & Osteoporosis Assoc /ID# 147567
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
P&I Clinical Research /ID# 151345
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904-3132
Country
United States
Facility Name
SW Rheumatology Res. LLC /ID# 142813
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Trinity Universal Research Association /ID# 149278
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-5283
Country
United States
Facility Name
Arthritis & Osteo Ctr of S. TX /ID# 142773
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Arthritis Clinic of Central TX /ID# 148346
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
DM Clinical Research /ID# 151007
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic /ID# 142760
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Western Washington Arthritis C /ID# 142776
City
Bothell
State/Province
Washington
ZIP/Postal Code
98021
Country
United States
Facility Name
Arthritis Northwest, PLLC /ID# 150924
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
The Vancouver Clinic, INC. PS /ID# 147946
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
West Virginia Research Inst /ID# 153087
City
South Charleston
State/Province
West Virginia
ZIP/Postal Code
25309
Country
United States
Facility Name
Aurora Rheumatology and Immunotherapy Center /ID# 142820
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
The Queen Elizabeth Hospital /ID# 142419
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Emeritus Research /ID# 142416
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Medizinische Universität Wien /ID# 142424
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Universitaetsklinik fuer Inner /ID# 142423
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Rheuma Zentrum Favoriten GmbH /ID# 142421
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Facility Name
Rheuma-Zentrum Wien-Oberlaa /ID# 142425
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Wilhelminenspital der Stadt Wien /ID# 142422
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Cliniques Universitaires Saint Luc /ID# 142426
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Rhumaconsult SPRL /ID# 151378
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ Gent /ID# 142429
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
ReumaClinic Genk /ID# 142431
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
AZ Damiaan /ID# 142427
City
Oostende
ZIP/Postal Code
8400
Country
Belgium
Facility Name
Ciads /Id# 142526
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3N 0K6
Country
Canada
Facility Name
Revmatologie MUDr. Klara Sirova /ID# 142536
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Medical Plus, s.r.o. /ID# 148345
City
Uherské Hradište
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
MediTrials /ID# 151777
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Facility Name
East Tallinn Central Hospital /ID# 142543
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Kiljava Medical Research /ID# 142546
City
Hyvinkaa
ZIP/Postal Code
05800
Country
Finland
Facility Name
Paijat-Hame Central Hospital /ID# 149185
City
Lahti
ZIP/Postal Code
15850
Country
Finland
Facility Name
CHR Orleans - Hopital de la Source /ID# 142557
City
Orleans CEDEX 2
State/Province
Centre-Val De Loire
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Universitaire Purpan /ID# 144697
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Saint Eloi /ID# 142552
City
Montpellier CEDEX 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Le Mans /ID# 145956
City
Le Mans CEDEX 9
State/Province
Sarthe
ZIP/Postal Code
72037
Country
France
Facility Name
CHU Bordeaux-Hopital Pellegrin /ID# 144700
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier Jean Rougie /ID# 142556
City
Cahors
ZIP/Postal Code
46005
Country
France
Facility Name
Hopital Edouard Herriot /ID# 144698
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Rheumazentrum Ruhrgebiet /ID# 145600
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44649
Country
Germany
Facility Name
Uniklinik Koln /ID# 142563
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Charité Universitätsmedizin Campus Mitte /ID# 142559
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Rheumaforschungszentrum II /ID# 142560
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Schoen Klinikum Hamburg Eilbek /ID# 142566
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Asklepios Klinik Altona /ID# 142561
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
LMU Klinikum der Universität München /ID# 142564
City
Munich
ZIP/Postal Code
80337
Country
Germany
Facility Name
MVZ Planegg /ID# 142565
City
Planegg
ZIP/Postal Code
82152
Country
Germany
Facility Name
Knappschaftsklinikum Saar /ID# 142562
City
Püttlingen
ZIP/Postal Code
66346
Country
Germany
Facility Name
General Hospital of Athens Laiko /ID# 142579
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Vital Medical Center Orvosi es /ID# 142586
City
Veszprém
State/Province
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Revita Reumatologiai Rendelo /ID# 142590
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142587
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Bekes Megyei Pandy Kalman Korh /ID# 142588
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
St Vincent's University Hosp /ID# 142593
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Tel Aviv Sourasky Medical Ctr /ID# 142597
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Bnai Zion Medical Center /ID# 151945
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
The Lady Davis Carmel MC /ID# 142599
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Hanyang University Seoul Hospi /ID# 150883
City
Seoul
State/Province
Seongdong-gu
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Inha University Hospital /ID# 150881
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 142622
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
LTD M+M Centers /ID# 142624
City
Adazi
ZIP/Postal Code
2164
Country
Latvia
Facility Name
P. Stradins Clinical Univ Hosp /ID# 142623
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Arthritis Clinic Ltd /ID# 153560
City
Riga
ZIP/Postal Code
LV-1050
Country
Latvia
Facility Name
Timaru Medical Specialists Ltd /ID# 142657
City
Timaru
ZIP/Postal Code
7910
Country
New Zealand
Facility Name
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 142665
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Pratia MCM Krakow /ID# 142664
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa /ID# 142667
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01-869
Country
Poland
Facility Name
Centrum Medyczne AMED Warszawa Targowek /ID# 142663
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia /ID# 142666
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Centro Hospitalar De Vila Nova /ID# 142670
City
Vila Nova De Gaia
State/Province
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, EPE /ID# 142668
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
GCM Medical Group /ID# 142671
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Family Outpatient clinic#4,LLC /ID# 150910
City
Korolev
State/Province
Moskva
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
ARTROMAC n.o. /ID# 142692
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Nemocnica Kosice Saca, a.s. /ID# 142693
City
Kosice
ZIP/Postal Code
040 15
Country
Slovakia
Facility Name
Narodny ustav reumatickych chorob Piestany /ID# 142691
City
Pieštany
ZIP/Postal Code
921 12
Country
Slovakia
Facility Name
H. Un. Marques de Valdecilla /ID# 142706
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Regional de Malaga /ID# 142707
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Comple Hosp Univ de A Coruna /ID# 142708
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Clin Univ San Carlos /ID# 142711
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clinica Gaias /ID# 142709
City
Santiago de Compostela
ZIP/Postal Code
15702
Country
Spain
Facility Name
Hospital Universitario La Fe /ID# 142716
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Sahlgrenska University Hosp /ID# 142720
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Capio Movement Halmstad /ID# 148236
City
Halmstad
ZIP/Postal Code
302 33
Country
Sweden
Facility Name
Orebro Universitetssjukhuset /ID# 142718
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Vastmanlands Sjukhus /ID# 142721
City
Vasteras
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Universitaetsspital Basel /ID# 145610
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
HFR Fribourg - Hopital Canton /ID# 142723
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
Hacettepe University Medical Faculty /ID# 142729
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Ataturk Training & Res /ID# 142727
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Ondokuz mayis University Facul /ID# 142728
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Whipps Cross Univ Hospital /ID# 145957
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
The Royal Free Hospital /ID# 142733
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Mid Essex Hospitals NHS Trust /ID# 148992
City
Chelmsford
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Western General Hospital /ID# 142732
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
West Suffolk Hospital /ID# 148993
City
Ipswich
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Facility Name
Queen Alexandra Hospital /ID# 142735
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Arrowe Park Hospital /ID# 148991
City
Wirral
ZIP/Postal Code
CH49 5PE
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
For details on when studies are available for sharing, please refer to the link below.
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
29908670
Citation
Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, Zhou Y, Mohamed MF, Meerwein S, Pangan AL. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. 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
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
31791386
Citation
Strand V, Schiff M, Tundia N, Friedman A, Meerwein S, Pangan A, Ganguli A, Fuldeore M, Song Y, Pope J. Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs. Arthritis Res Ther. 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8.
Results Reference
derived
PubMed Identifier
31610021
Citation
Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.
Results Reference
derived
Links:
URL
https://www.rxabbvie.com/
Description
Related Info.
Learn more about this trial
A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
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