A Study Comparing Upadacitinib (ABT-494) to Placebo in Pa... | NCT03104374 | Trialant
NCT03104374
Sponsor
AbbVie
Status
Completed
Last Update Posted
Sep 11, 2025Actual
Enrollment
642Actual
Phase
Phase 3
Conditions
Psoriatic Arthritis
Interventions
Placebo
Upadacitinib
Countries
United States
Australia
Belgium
Brazil
Canada
Chile
Czechia
France
Greece
Hungary
Italy
Japan
Netherlands
New Zealand
Portugal
Puerto Rico
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03104374
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M15-554
Secondary IDs
ID
Type
Description
Link
2016-004152-30
EudraCT Number
Brief Title
A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
Official Title
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)
Acronym
SELECT - PsA 2
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 1, 2017Actual
Primary Completion Date
Jul 23, 2019Actual
Completion Date
Sep 30, 2024Actual
First Submitted Date
Apr 4, 2017
First Submission Date that Met QC Criteria
Apr 4, 2017
First Posted Date
Apr 7, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 27, 2021
Results First Submitted that Met QC Criteria
Dec 27, 2021
Results First Posted Date
Jan 25, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 14, 2020
Certification/Extension First Submitted that Passed QC Review
Jul 14, 2020
Certification/Extension First Posted Date
Jul 16, 2020Actual
Last Update Submitted Date
Aug 22, 2025
Last Update Posted Date
Sep 11, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 3 multicenter study that included two periods. Period 1 was designed to compare the safety, tolerability, and efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who had an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluated the safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who completed Period 1.
Detailed Description
The study included a 35-day screening period; a 56-week blinded period which included 24 weeks of randomized, double-blind, parallel-group, placebo-controlled treatment followed by an additional 32 weeks of treatment blinded to the dose of upadacitinib (Period 1); a long-term extension period of up to a total treatment duration of up to approximately 3 years (Period 2); and a 30-day follow-up call or visit.
All participants in Period 1 who were randomized to receive Placebo up to 24 weeks were pooled for the assessment of all outcome measures. All participants receiving upadacitinib 30 mg QD during Period 2 were switched to upadacitinib 15 mg QD following a protocol amendment and were pooled for AE reporting.
Conditions Module
Conditions
Psoriatic Arthritis
Keywords
Arthritis
Psoriasis
Anti-Rheumatic
Anti-inflammatory
Joint disease
Musculoskeletal disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
642Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Upadacitinib 15 mg
Experimental
Administered once daily.
Drug: Upadacitinib
Placebo / Upadacitinib 30 mg
Placebo Comparator
Administered once daily.
Drug: Placebo
Drug: Upadacitinib
Upadacitinib 30 mg
Experimental
Administered once daily.
Drug: Upadacitinib
Placebo / Upadacitinib 15 mg
Placebo Comparator
Administered once daily.
Drug: Placebo
Drug: Upadacitinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Oral tablet
Placebo / Upadacitinib 15 mg
Placebo / Upadacitinib 30 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response 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).
Baseline and Week 12
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD.
Exclusion Criteria:
Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than Methotrexate (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast, Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Participants were randomly assigned at a 1:1:2:2 ratio to one of four treatment groups below. Randomization was stratified by extent of psoriasis (≥ 3% body surface area [BSA] or < 3% BSA), current use of at least 1 DMARD, and number of prior failed biologic DMARDs (1 vs > 1), except for participants from Japan, for whom randomization was stratified by extent of psoriasis (≥ 3% BSA or < 3% BSA) only.
Recruitment Details
This study was conducted at 123 sites in 16 countries (Belgium, Brazil, Canada, Chile, Czech Republic, France, Greece, Hungary, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, United Kingdom, United States [including Puerto Rico]).
Adults with active psoriatic arthritis (PsA) and a history of inadequate response or intolerance to at least one biologic disease modifying anti-rheumatic drug (bDMARD) were enrolled.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo / Upadacitinib 15 mg
Participants randomized to receive placebo once daily up to week 24 followed by upadacitinib 15 mg once daily. All participants in Period 1 who were randomized to receive Placebo up to 24 weeks were pooled for the assessment of all outcome measures.
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe).
Baseline and Week 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).
The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score.
Baseline and Week 16
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.
Baseline and Week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Baseline and Week 12
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
A participant was classified as achieving MDA if 5 of the following 7 criteria were met:
Tender joint count (out of 68 joints) ≤ 1
Swollen joint count (out of 66 joints) ≤ 1
PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3%
Patient's assessment of pain ≤ 1.5 (NRS from 0 to 10)
Patient's Global Assessment of disease activity ≤ 2 (NRS from 0 to 10)
HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3)
Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)
Week 24
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16
The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement.
Baseline and Week 16
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).
Baseline and Week 12
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).
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
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).
Baseline and Week 2
Mesa
Arizona
85210-6871
United States
Sun Valley Arthritis Center Ltd. /ID# 161203
Peoria
Arizona
85381
United States
Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 160006
Phoenix
Arizona
85032-9306
United States
Osteoporosis Medical Center /ID# 161411
Beverly Hills
California
90211
United States
Covina Arthritis Clinic /ID# 159919
Covina
California
91722
United States
Triwest Research Associates /ID# 159915
El Cajon
California
92020
United States
Duplicate_Providence Medical Foundation /ID# 160005
Fullerton
California
92835
United States
C.V. Mehta MD, Med Corporation /ID# 161192
Hemet
California
92543
United States
Care Access Research, Huntington Beach /ID# 160049
Duplicate_Kitakyushu Municipal Medical Center /ID# 163516
Kitakyushu-shi
Fukuoka
802-8561
Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 161472
Kitakyushu-shi
Fukuoka
807-8556
Japan
Asahikawa Medical University Hospital /ID# 200684
Asahikawa-shi
Hokkaido
078-8510
Japan
Mie University Hospital /ID# 162085
Tsu
Mie-ken
514-8507
Japan
Tohoku University Hospital /ID# 164035
Sendai
Miyagi
9808574
Japan
Oribe Clinic of Rheumatism and Medicine /ID# 163704
Ōita
Oita Prefecture
870-0823
Japan
Kansai Medical University Hospital /ID# 162081
Hirakata-shi
Osaka
573-1191
Japan
National Hospital Organization Osaka Minami Medical Center /ID# 162589
Kawachinagano Shi
Osaka
586-8521
Japan
Osaka Metropolitan University Hospital /ID# 162082
Osaka
Osaka
545-8586
Japan
Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773
Osaka
Osaka
550-0006
Japan
Juntendo University Hospital /ID# 162089
Bunkyo-ku
Tokyo
113-8431
Japan
St.Luke's International Hospital /ID# 162013
Chuo-ku
Tokyo
104-8560
Japan
Keio University Hospital /ID# 162130
Shinjuku-ku
Tokyo
160-8582
Japan
Medisch Centrum Leeuwarden /ID# 163049
Leeuwarden
South Holland
8934 AD
Netherlands
Duplicate_Erasmus Medisch Centrum /ID# 163052
Rotterdam
South Holland
3015 GD
Netherlands
Maasstad Ziekenhuis /ID# 163050
Rotterdam
South Holland
3079 DZ
Netherlands
Sint Maartenskliniek /ID# 163703
Ubbergen
6574 NA
Netherlands
Duplicate_Middlemore Hospital /ID# 166411
Otahuhu
Auckland
2025
New Zealand
Timaru Medical Specialists Ltd /ID# 166410
Timaru
Canterbury
7910
New Zealand
Waikato Hospital /ID# 166412
Hamilton
Waikato Region
3240
New Zealand
Porter Rheumatology Ltd /ID# 200422
Nelson
7010
New Zealand
Duplicate_Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 165897
Vila Nova de Gaia
Porto District
4434-502
Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 165898
Ponte de Lima
Viana do Castelo District
4990-041
Portugal
Instituto Portugues De Reumatologia /ID# 165894
Lisbon
1050-034
Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 165896
Lisbon
1349-019
Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 165895
Lisbon
1649-035
Portugal
Alma M. Cruz Santana, MD-Private practice /ID# 163308
Carolina
00985
Puerto Rico
Ponce Medical School Foundation /ID# 163918
Ponce
00716-0377
Puerto Rico
GCM Medical Group PSC /ID# 163716
San Juan
00917-3104
Puerto Rico
Duplicate_Ajou University Hospital /ID# 163893
Suwon
Gyeonggido
16499
South Korea
Duplicate_Inha University Hospital /ID# 163892
Junggu
Incheon Gwang Yeogsi
22332
South Korea
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138
El Palmar
Murcia
30120
Spain
Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 161019
A Coruña
15006
Spain
Duplicate_Hospital Universitario Reina Sofia /ID# 170764
Córdoba
14004
Spain
Hospital Campus de la Salud /ID# 170768
Granada
18016
Spain
Hospital Universitario Ramon y Cajal /ID# 161020
Madrid
28034
Spain
Royal United Hospitals Bath /ID# 161054
Bath
Bath And North East Somerset
BA1 3NG
United Kingdom
Barts Health NHS Trust /ID# 161053
London
London, City of
E1 2ES
United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 161063
London
London, City of
SE1 9RT
United Kingdom
Duplicate_NHS Greater Glasgow and Clyde /ID# 162712
Glasgow
G12 0XH
United Kingdom
Duplicate_Bedfordshire Hospitals NHS Foundation Trust /ID# 162713
Luton
LU4 0DZ
United Kingdom
Duplicate_Christchurch University Hospitals Dorset NHS University Hospitals Dors /ID# 162711
Poole
BH15 2JB
United Kingdom
Derived
Burmester GR, Stigler J, Rubbert-Roth A, Tanaka Y, Azevedo VF, Coombs D, Lagunes I, Lippe R, Wung P, Gensler LS. Safety Profile of Upadacitinib up to 5 Years in Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis: An Integrated Analysis of Clinical Trials. Rheumatol Ther. 2024 Jun;11(3):737-753. doi: 10.1007/s40744-024-00671-4. Epub 2024 Apr 29.
Cantini F, Marchesoni A, Novelli L, Gualberti G, Marando F, McDearmon-Blondell EL, Gao T, McGonagle D, Salvarani C. Effects of upadacitinib on enthesitis in patients with psoriatic arthritis: a post hoc analysis of SELECT-PsA 1 and 2 trials. Rheumatology (Oxford). 2024 Nov 1;63(11):3146-3154. doi: 10.1093/rheumatology/keae057.
Rubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.
Mease P, Setty A, Papp K, Van den Bosch F, Tsuji S, Keiserman M, Carter K, Li Y, McCaskill R, McDearmon-Blondell E, Wung P, Tillett W. Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study. Clin Exp Rheumatol. 2023 Nov;41(11):2286-2297. doi: 10.55563/clinexprheumatol/8l7bbk. Epub 2023 Jul 5.
Mease P, Kavanaugh A, Gladman D, FitzGerald O, Soriano ER, Nash P, Feng D, Lertratanakul A, Douglas K, Lippe R, Gossec L. Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials. Rheumatol Ther. 2022 Aug;9(4):1181-1191. doi: 10.1007/s40744-022-00449-6. Epub 2022 May 23.
Burmester GR, Winthrop K, Blanco R, Nash P, Goupille P, Azevedo VF, Salvarani C, Rubbert-Roth A, Lesser E, Lippe R, Lertratanakul A, Mccaskill RM, Liu J, Ruderman EM. Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. Rheumatol Ther. 2022 Apr;9(2):521-539. doi: 10.1007/s40744-021-00410-z. Epub 2021 Dec 30.
Nash P, Richette P, Gossec L, Marchesoni A, Ritchlin C, Kato K, McDearmon-Blondell EL, Lesser E, McCaskill R, Feng D, Anderson JK, Ruderman EM. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology (Oxford). 2022 Aug 3;61(8):3257-3268. doi: 10.1093/rheumatology/keab905.
Strand V, Van den Bosch F, Ranza R, Leung YY, Drescher E, Zueger P, Saffore CD, Lertratanakul A, Lippe R, Nash P. Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2. Rheumatol Ther. 2021 Dec;8(4):1827-1844. doi: 10.1007/s40744-021-00377-x. Epub 2021 Oct 18.
Muensterman E, Engelhardt B, Gopalakrishnan S, Anderson JK, Mohamed MF. Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients - Analyses of phase III clinical trials. Clin Transl Sci. 2022 Jan;15(1):267-278. doi: 10.1111/cts.13146. Epub 2021 Oct 27.
Mease PJ, Lertratanakul A, Papp KA, van den Bosch FE, Tsuji S, Dokoupilova E, Keiserman MW, Bu X, Chen L, McCaskill RM, Zueger P, McDearmon-Blondell EL, Pangan AL, Tillett W. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021 Jun;8(2):903-919. doi: 10.1007/s40744-021-00305-z. Epub 2021 Apr 28.
Mease PJ, Lertratanakul A, Anderson JK, Papp K, Van den Bosch F, Tsuji S, Dokoupilova E, Keiserman M, Wang X, Zhong S, McCaskill RM, Zueger P, Pangan AL, Tillett W. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021 Mar;80(3):312-320. doi: 10.1136/annrheumdis-2020-218870. Epub 2020 Dec 3.
Placebo / Upadacitinib 30 mg
Participants randomized to receive placebo once daily up to week 24 followed by upadacitinib 30 mg once daily. All participants in Period 1 who were randomized to receive Placebo up to 24 weeks were pooled for the assessment of all outcome measures. Participants in this group were switched to upadacitinib 15mg QD during Period 2 after week 116, following a protocol amendment.
FG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily.
FG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg once daily. Participants in this group were switched to upadacitinib 15mg QD during Period 2 after week 116, following a protocol amendment.
FG000106 subjects
FG001106 subjects
FG002211 subjects
FG003219 subjects
Received Study Drug
FG000106 subjects
FG001106 subjects
FG002211 subjects
FG003218 subjectsOne randomized participant did not qualify per inclusion/exclusion criteria and discontinued prior to treatment.
Completed Week 24
FG00081 subjects
FG00192 subjects
FG002192 subjects
FG003195 subjects
COMPLETED
Completed Week 56 (Period 1)
FG00069 subjects
FG00177 subjects
FG002167 subjects
FG003166 subjects
NOT COMPLETED
FG00037 subjects
FG00129 subjects
FG00244 subjects
FG00353 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0017 subjects
FG00212 subjects
FG00314 subjects
Withdrawal by Subject
FG00018 subjects
FG0019 subjects
FG00210 subjects
FG00317 subjects
Lost to Follow-up
FG0004 subjects
FG0014 subjects
FG0026 subjects
FG0038 subjects
Lack of Efficacy
FG0006 subjects
FG0017 subjects
FG00212 subjects
FG0036 subjects
Other
FG0002 subjects
FG0012 subjects
FG0024 subjects
FG0037 subjects
One participant did not qualify per inclusion/exclusion criteria and discontinued prior to treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Period 2
Type
Comment
Milestone Data
STARTED
FG00069 subjects
FG00177 subjects
FG002167 subjects
FG003165 subjectsOne participant who completed Period 1 did not enter Period 2.
Switched to 15mg QD Upa Dosing in Period 2
Participants receiving 30 mg once daily switched to 15 mg once daily during Period 2.
FG0000 subjects
FG00128 subjects
FG0020 subjects
FG003
COMPLETED
FG00055 subjects
FG00155 subjects
FG002131 subjects
FG003126 subjects
NOT COMPLETED
FG00014 subjects
FG00122 subjects
FG00236 subjects
FG00339 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0017 subjects
FG00210 subjects
FG003
The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo once daily for 24 weeks. This group includes all participants who went on to receive upadacitinib 15 mg or upadacitinib 30 mg after week 24.
BG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
BG002
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000212
BG001211
BG002218
BG003641
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002218
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Extent of Psoriasis
The extent of psoriasis was measured by the physician as the total body surface area (BSA) involved with psoriasis. For purposes of clinical estimation, the total surface of the participant's palm and five digits was assumed to be approximately equivalent to 1% of BSA.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Number of Prior Failed Biologic DMARDs
Failed treatment with prior biologic DMARD is defined as lack of efficacy after a minimum 12 week duration of therapy. The zero category includes participants with intolerance but not inadequate response to a biologic DMARD.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Duration of Psoriatic Arthritis Symptoms
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Duration of PsA Diagnosis
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Tender Joint Count
A total of 68 joints were assessed for the presence or absence of tenderness.
Mean
Standard Deviation
joints
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Swollen Joint Count
A total of 66 joints were assessed for the presence or absence of swelling.
Mean
Standard Deviation
joints
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Patient's Assessment of Pain
Participants were asked to indicate the severity of their arthritis pain within the previous week on a numeric rating scale (NRS) from 0 to 10. A score of 0 indicates "no pain" and a score of 10 indicates "worst possible pain."
Participants with available data
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000209
ParticipantsBG001208
ParticipantsBG002
Patient's Global Assessment of Disease Activity
The participant was asked to rate their current psoriatic arthritis disease activity on a 0 to 10 NRS, where 0 indicates no disease activity and 10 indicates severe disease activity.
Participants with available data
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000209
ParticipantsBG001208
ParticipantsBG002
Physician's Global Assessment of Disease Activity
The physician rated the participant's current global psoriatic arthritis disease activity (independently from the participant's assessment) on a 0 to 10 NRS where 0 indicates no disease activity and 10 indicates severe disease activity.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Health Assessment Questionnaire - Disability Index (HAQ-DI)
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.
Participants with available data
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000209
ParticipantsBG001
High-sensitivity C-reactive Protein (hsCRP)
Mean
Standard Deviation
mg/L
Title
Denominators
Categories
ParticipantsBG000212
ParticipantsBG001211
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response 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).
Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
OG002
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
Units
Counts
Participants
OG000212
OG001211
OG002218
Title
Denominators
Categories
Title
Measurements
OG00024.1(18.3 to 29.8)
OG00156.9(50.2 to 63.6)
OG00263.8(57.4 to 70.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
32.8
2-Sided
95
24.0
41.6
Response Rate Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
Secondary
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.
Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
OG002
Upadacitinib 30 mg
Secondary
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe).
Full analysis set participants with a Baseline sIGA score ≥ 2; participants who prematurely discontinued from study drug prior to Week 16 or for whom sIGA data were missing at Week 16 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
OG002
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
Secondary
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).
The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score.
Full analysis set participants with Baseline psoriasis BSA involvement ≥ 3%; participants who prematurely discontinued from study drug prior to Week 16 or for whom PASI data were missing at Week 16 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
Secondary
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.
Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
OG002
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
OG002
Secondary
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
A participant was classified as achieving MDA if 5 of the following 7 criteria were met:
Tender joint count (out of 68 joints) ≤ 1
Swollen joint count (out of 66 joints) ≤ 1
PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3%
Patient's assessment of pain ≤ 1.5 (NRS from 0 to 10)
Patient's Global Assessment of disease activity ≤ 2 (NRS from 0 to 10)
HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3)
Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)
Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom data were missing at Week 24, or who met rescue criteria at Week 16 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
OG002
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
Secondary
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16
The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement.
Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 16 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
OG002
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
Secondary
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).
Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
OG002
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
Secondary
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).
Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
OG002
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
Secondary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
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 analysis set; participants who prematurely discontinued from study drug prior to Week 2 or for whom ACR data were missing at Week 2 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 2
ID
Title
Description
OG000
Placebo
Participants received placebo once daily for 24 weeks.
OG001
Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 24 weeks.
OG002
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
Time Frame
All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. For Period 1, the median time participants were followed was: 414 days (15mg Upa); 413 days (30mg Upa); 190 days (Pooled Placebo ICF to week 24); 415 days (Pbo 15mg Upa); and 415 days (Pbo 30mg Upa). For Period 2, the median time participants were followed was: 712 days (15mg Upa); 701 days (30mg Upa); 703 days (Pbo 15mg Upa); 672 days (Pbo 30mg Upa); and 223 days (Switched to 15mg Upa).
Description
Participants receiving Upadacitinib 30 mg once daily were switched to Upadacitinib 15 mg once daily during Period 2. Following the switch, adverse events were pooled for these participants to end-of-study (EOS).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Period 1: Upadacitinib 15 mg (ICF to Week 56)
Participants randomized to receive Upadacitinib 15 mg once daily to Week 56.
0
211
22
211
111
211
EG001
Period 1: Upadacitinib 30 mg (ICF to Week 56)
Participants randomized to receive Upadacitinib 30 mg once daily to Week 56.
0
219
25
219
139
219
EG002
Period 1: Pooled Placebo (ICF to Week 24)
This group includes all participants in Period 1 who were randomized to receive Placebo once daily to Week 24.
1
212
5
212
87
212
EG003
Period 1: Placebo / Upadacitinib 15 mg (Week 24 to Week 56)
Participants were randomized to receive placebo once daily for 24 weeks followed by upadacitinib 15 mg once daily to Week 56. AEs in this group were reported while participants received 15 mg upadacitinib from Week 24 to Week 56.
0
79
3
79
32
79
EG004
Period 1: Placebo / Upadacitinib 30 mg (Week 24 to Week 56)
Participants were randomized to receive placebo once daily for 24 weeks followed by upadacitinib 30 mg once daily to Week 56. AEs in this group were reported while participants received 30 mg upadacitinib from Week 24 to Week 56.
0
90
6
90
34
90
EG005
Period 2: Upadacitinib 15 mg (Week 56 to EOS)
Participants randomized to receive upadacitinib 15 mg once daily in Period 2 from Week 56 to EOS.
5
167
24
167
111
167
EG006
Period 2: Upadacitinib 30 mg (Week 56 to EOS)
Participants randomized to receive upadacitinib 30 mg once daily in Period 2 from Week 56 to EOS. Participants in this group were switched to upadacitinib 15 mg once daily during Period 2 after week 116, following a protocol amendment.
0
165
19
165
99
165
EG007
Period 2: Placebo / Upadacitinib 15 mg (Week 56 to Week EOS)
Participants from the Period 1 Placebo / Upadacitinib 15 mg group received 15 mg upadacitinib once daily from Week 56 to EOS.
0
69
7
69
42
69
EG008
Period 2: Placebo / Upadacitinib 30 mg (Week 56 to EOS)
Participants from the Period 1 Placebo / Upadacitinib 30 mg group were to receive 30 mg upadacitinib once daily from Week 56 to EOS. Participants in this group were switched to upadacitinib 15 mg once daily during Period 2 after week 116, following a protocol amendment.
2
77
12
77
49
77
EG009
Period 2: Pooled Upadacitinib Groups Who Switched From 30 mg to 15 mg in Period 2
All participants in Period 2 who switched from 30 mg to 15 mg upadacitinib to EOS during Period 2. This group includes all participants who received any upadacitinib 30 mg in Period 2 and switched dose to upadacitinib 15 mg once daily during Period 2 (following a protocol amendment, after week 116). The AEs in this group were reported while participants received 15 mg upadacitinib once daily.
0
87
5
87
34
87
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
BLOOD LOSS ANAEMIA
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected167 at risk
EG0061 events1 affected165 at risk
EG0070 events0 affected69 at risk
EG0080 events0 affected77 at risk
EG0090 events0 affected87 at risk
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ACUTE MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ANGINA PECTORIS
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ANGINA UNSTABLE
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0021 events1 affected212 at risk
EG003
AORTIC VALVE STENOSIS
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
BRADYCARDIA
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CARDIO-RESPIRATORY ARREST
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CORONARY ARTERY STENOSIS
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
VENTRICULAR FIBRILLATION
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ADRENAL INSUFFICIENCY
Endocrine disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
GOITRE
Endocrine disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
RETINAL DETACHMENT
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
COLITIS ULCERATIVE
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
DUODENAL ULCER
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
DUODENAL ULCER HAEMORRHAGE
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
GASTRITIS EROSIVE
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
HAEMATEMESIS
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
INGUINAL HERNIA
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PANCREATITIS ACUTE
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SMALL INTESTINE ULCER
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CHEST PAIN
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0021 events1 affected212 at risk
EG003
DEATH
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PYREXIA
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CHOLECYSTITIS ACUTE
Hepatobiliary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
DRUG-INDUCED LIVER INJURY
Hepatobiliary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ABSCESS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ANAL ABSCESS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
BRONCHIOLITIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
BURSITIS INFECTIVE STAPHYLOCOCCAL
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0021 events1 affected212 at risk
EG003
COVID-19
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
COVID-19 PNEUMONIA
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CYTOMEGALOVIRUS INFECTION
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
EXTRADURAL ABSCESS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
HIV INFECTION
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
LIVER ABSCESS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION BACTERIAL
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
MENINGITIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
OSTEOMYELITIS ACUTE
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0003 events3 affected211 at risk
EG0013 events3 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PNEUMONIA INFLUENZAL
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SEPSIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SUBCUTANEOUS ABSCESS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CERVICAL VERTEBRAL FRACTURE
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
FEMORAL NECK FRACTURE
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
FIBULA FRACTURE
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0021 events1 affected212 at risk
EG003
LUMBAR VERTEBRAL FRACTURE
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
POST PROCEDURAL BILE LEAK
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0021 events1 affected212 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0021 events1 affected212 at risk
EG003
SKULL FRACTURED BASE
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SUBDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
TENDON RUPTURE
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
THORACIC VERTEBRAL FRACTURE
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
TRAUMATIC HAEMOTHORAX
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
VASCULAR PSEUDOANEURYSM
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0021 events1 affected212 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
DIABETIC KETOACIDOSIS
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
METABOLIC ACIDOSIS
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
TYPE 1 DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PSORIATIC ARTHROPATHY
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0002 events2 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
RAPIDLY PROGRESSIVE OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SYSTEMIC LUPUS ERYTHEMATOSUS
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ADENOCARCINOMA OF COLON
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ANOGENITAL WARTS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
GASTROINTESTINAL CANCER METASTATIC
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
GASTROINTESTINAL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
INTRADUCTAL PAPILLARY BREAST NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
MALIGNANT MELANOMA STAGE III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
NEOPLASM MALIGNANT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
NEUROENDOCRINE CARCINOMA OF THE SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
OROPHARYNGEAL SQUAMOUS CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
OVARIAN CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
OVARIAN THECA CELL TUMOUR
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PARATHYROID TUMOUR BENIGN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PROSTATE CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
RECTAL ADENOCARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
RECTAL CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
UTERINE LEIOMYOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0021 events1 affected212 at risk
EG003
BRAIN OEDEMA
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CAROTID ARTERY INSUFFICIENCY
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
FACIAL PARALYSIS
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
GENERALISED TONIC-CLONIC SEIZURE
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SPEECH DISORDER
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SUBARACHNOID HAEMORRHAGE
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
TRANSIENT GLOBAL AMNESIA
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ABORTION SPONTANEOUS
Pregnancy, puerperium and perinatal conditions
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ECTOPIC PREGNANCY
Pregnancy, puerperium and perinatal conditions
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
DEVICE DISLOCATION
Product Issues
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
DISORIENTATION
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
MENTAL STATUS CHANGES
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SUICIDE ATTEMPT
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0002 events2 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
BENIGN PROSTATIC HYPERPLASIA
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CERVICAL DYSPLASIA
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
HAEMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0021 events1 affected212 at risk
EG003
INTERSTITIAL LUNG DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
SUBCUTANEOUS EMPHYSEMA
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
CIRCULATORY COLLAPSE
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
DIARRHOEA
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0008 events8 affected211 at risk
EG00118 events15 affected219 at risk
EG00213 events12 affected212 at risk
EG0034 events3 affected79 at risk
EG0043 events3 affected90 at risk
EG0055 events5 affected167 at risk
EG0065 events3 affected165 at risk
EG0071 events1 affected69 at risk
EG0082 events2 affected77 at risk
EG0094 events4 affected87 at risk
NAUSEA
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0008 events8 affected211 at risk
EG00112 events12 affected219 at risk
EG0028 events7 affected212 at risk
EG003
HEPATIC STEATOSIS
Hepatobiliary disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0013 events3 affected219 at risk
EG0021 events1 affected212 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG00020 events17 affected211 at risk
EG00116 events15 affected219 at risk
EG0025 events5 affected212 at risk
EG003
COVID-19
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0010 events0 affected219 at risk
EG0020 events0 affected212 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0008 events8 affected211 at risk
EG00113 events13 affected219 at risk
EG0022 events2 affected212 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG00016 events14 affected211 at risk
EG00114 events13 affected219 at risk
EG0023 events3 affected212 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG00029 events24 affected211 at risk
EG00134 events29 affected219 at risk
EG00218 events17 affected212 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected211 at risk
EG0013 events3 affected219 at risk
EG0022 events2 affected212 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0009 events8 affected211 at risk
EG00110 events9 affected219 at risk
EG00211 events9 affected212 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0003 events3 affected211 at risk
EG0014 events3 affected219 at risk
EG0021 events1 affected212 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG00027 events22 affected211 at risk
EG00134 events29 affected219 at risk
EG00213 events10 affected212 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG00024 events19 affected211 at risk
EG00118 events16 affected219 at risk
EG00214 events12 affected212 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (27.0)
Systematic Assessment
EG0005 events5 affected211 at risk
EG00113 events11 affected219 at risk
EG0021 events1 affected212 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
MedDRA (27.0)
Systematic Assessment
EG00010 events9 affected211 at risk
EG00129 events22 affected219 at risk
EG0024 events4 affected212 at risk
EG003
DYSLIPIDAEMIA
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected211 at risk
EG0011 events1 affected219 at risk
EG0020 events0 affected212 at risk
EG003
PSORIATIC ARTHROPATHY
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG00014 events13 affected211 at risk
EG0018 events7 affected219 at risk
EG00212 events11 affected212 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0009 events8 affected211 at risk
EG00110 events10 affected219 at risk
EG00212 events10 affected212 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
39.7
2-Sided
95
31.1
48.3
Response Rate Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
Participants received upadacitinib 30 mg once daily for 24 weeks.
Units
Counts
Participants
OG000180
OG001199
OG002204
Title
Denominators
Categories
Title
Measurements
OG000-0.10(-0.16 to -0.03)
OG001-0.30(-0.37 to -0.24)
OG002-0.41(-0.47 to -0.35)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Effect Model Repeated Measurement
MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.
<0.0001
Least Squares (LS) Mean Difference
-0.21
2-Sided
95
-0.30
-0.12
Treatment Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
OG000
OG002
Mixed Effect Model Repeated Measurement
MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.
<0.0001
LS Mean Difference
-0.31
2-Sided
95
-0.40
-0.22
Treatment Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
Units
Counts
Participants
OG000163
OG001171
OG002164
Title
Denominators
Categories
Title
Measurements
OG0009.2(4.8 to 13.6)
OG00136.8(29.6 to 44.1)
OG00240.2(32.7 to 47.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
27.6
2-Sided
95
19.2
36.1
Response Rate Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
31.0
2-Sided
95
22.3
39.8
Response Rate Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
OG002
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
Units
Counts
Participants
OG000131
OG001130
OG002131
Title
Denominators
Categories
Title
Measurements
OG00016.0(9.7 to 22.3)
OG00152.3(43.7 to 60.9)
OG00256.5(48.0 to 65.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
36.3
2-Sided
95
25.6
46.9
Response Rate Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
40.5
2-Sided
95
29.9
51.0
Response Rate Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
Units
Counts
Participants
OG000185
OG001201
OG002206
Title
Denominators
Categories
Title
Measurements
OG0001.62(0.58 to 2.67)
OG0015.15(4.14 to 6.15)
OG0027.06(6.07 to 8.06)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Effect Model Repeated Measurement
MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.
<0.0001
LS Mean Difference
3.52
2-Sided
95
2.07
4.98
Treatment Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
OG000
OG002
Mixed Effect Model Repeated Measurement
MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.
<0.0001
LS Mean Difference
5.44
2-Sided
95
3.99
6.88
Treatment Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 24 weeks.
Units
Counts
Participants
OG000184
OG001201
OG002206
Title
Denominators
Categories
Title
Measurements
OG0001.3(0.1 to 2.5)
OG0015.0(3.8 to 6.1)
OG0026.1(4.9 to 7.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Effect Model Repeated Measurement
MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.
<0.0001
LS Mean Difference
3.7
2-Sided
95
2.0
5.4
Treatment Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
OG000
OG002
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
Mixed Effect Model Repeated Measurement
MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.
<0.0001
LS Mean Difference
4.8
2-Sided
95
3.1
6.4
Treatment Difference = Upadacitinib - Placebo
Superiority
Units
Counts
Participants
OG000212
OG001211
OG002218
Title
Denominators
Categories
Title
Measurements
OG0002.8(0.6 to 5.1)
OG00125.1(19.3 to 31.0)
OG00228.9(22.9 to 34.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
22.3
2-Sided
95
16.0
28.6
Response Rate Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
26.1
2-Sided
95
19.7
32.5
Response Rate Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
Units
Counts
Participants
OG000182
OG001191
OG002200
Title
Denominators
Categories
Title
Measurements
OG000-1.5(-4.7 to 1.8)
OG001-24.4(-27.5 to -21.2)
OG002-29.7(-32.8 to -26.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Effect Model Repeated Measurement
MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.
<0.0001
LS Mean Difference
-22.9
2-Sided
95
-27.4
-18.4
Treatment Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
OG000
OG002
Mixed Effect Model Repeated Measurement
MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.
<0.0001
LS Mean Difference
-28.2
2-Sided
95
-32.7
-23.8
Treatment Difference = Upadacitinib - Placebo
Superiority
The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.
Units
Counts
Participants
OG000212
OG001211
OG002218
Title
Denominators
Categories
Title
Measurements
OG0004.7(1.9 to 7.6)
OG00131.8(25.5 to 38.0)
OG00237.6(31.2 to 44.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
27.0
2-Sided
95
20.1
33.9
Response Rate Difference = Upadacitinib - Placebo
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
32.9
2-Sided
95
25.9
39.9
Response Rate Difference = Upadacitinib - Placebo
Superiority
Units
Counts
Participants
OG000212
OG001211
OG002218
Title
Denominators
Categories
Title
Measurements
OG0000.5(0.0 to 1.4)
OG0018.5(4.8 to 12.3)
OG00216.5(11.6 to 21.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
8.1
2-Sided
95
4.2
11.9
Response Rate Difference = Upadacitinib - Placebo
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
16.0
2-Sided
95
11.0
21.1
Response Rate Difference = Upadacitinib - Placebo
Superiority
Units
Counts
Participants
OG000212
OG001211
OG002218
Title
Denominators
Categories
Title
Measurements
OG00010.8(6.7 to 15.0)
OG00132.7(26.4 to 39.0)
OG00233.5(27.2 to 39.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).
<0.0001
Response Rate Difference
21.9
2-Sided
95
14.3
29.4
Response Rate Difference = Upadacitinib - Placebo
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).