A Study to Evaluate the Safety and Efficacy of Upadacitin... | NCT03725202 | Trialant
NCT03725202
Sponsor
AbbVie
Status
Completed
Last Update Posted
Feb 24, 2026Actual
Enrollment
429Actual
Phase
Phase 3
Conditions
Giant Cell Arteritis (GCA)
Interventions
Upadacitinib
Corticosteroid (CS)
Placebo
Countries
United States
Australia
Austria
Belgium
Canada
Czechia
Denmark
France
Germany
Greece
Hungary
Israel
Italy
Japan
Netherlands
New Zealand
Norway
Portugal
Romania
Russia
Spain
Sweden
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03725202
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M16-852
Secondary IDs
ID
Type
Description
Link
2023-505476-29-00
Other Identifier
EU CT
2017-003978-13
EudraCT Number
Brief Title
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA
Acronym
SELECT-GCA
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Feb 2026
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
Jan 24, 2019Actual
Primary Completion Date
Feb 6, 2024Actual
Completion Date
Mar 11, 2025Actual
First Submitted Date
Oct 27, 2018
First Submission Date that Met QC Criteria
Oct 27, 2018
First Posted Date
Oct 30, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jan 30, 2025
Results First Submitted that Met QC Criteria
Feb 25, 2025
Results First Posted Date
Mar 7, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 4, 2026
Last Update Posted Date
Feb 24, 2026Actual
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 study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.
Detailed Description
Not provided
Conditions Module
Conditions
Giant Cell Arteritis (GCA)
Keywords
Giant Cell Arteritis (GCA)
ABT-494
Upadacitinib
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
429Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo + 52-week CS taper
Placebo Comparator
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
Drug: Corticosteroid (CS)
Other: Placebo
7.5 mg Upadacitinib + 26-week CS taper
Experimental
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Drug: Upadacitinib
Drug: Corticosteroid (CS)
15 mg Upadacitinib + 26-week CS taper
Experimental
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Drug: Upadacitinib
Drug: Corticosteroid (CS)
Placebo + 52-week CS taper -> Placebo
Placebo Comparator
Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR at remission at the Week 52 visit only who were assigned to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
Percentage of Participants Achieving Sustained Remission at Week 52
Sustained remission is defined as having achieved absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52, and adherence to the protocol-defined corticosteroid (CS) taper regimen.
From Week 12 to Week 52
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52
Sustained complete remission is defined as having absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52; normalization of erythrocyte sedimentation rate (ESR); normalization of high sensitivity C-reactive protein (hs-CRP) and adherence to the protocol-defined CS taper regimen.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of giant cell arteritis (GCA) according to the following criteria:
History of erythrocyte sedimentation rate (ESR) >= 50 mm/hour or high sensitivity C-reactive protein (hsCRP)/CRP >=1.0 mg/dL
Presence of at least one of the following: Unequivocal cranial symptoms of GCA or Unequivocal symptoms of polymyalgia rheumatica (PMR)
Presence of at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large vessel vasculitis by angiography or cross-sectional imaging such as ultrasound, magnetic resonance imaging (MRI), computed tomography (CT) or positron emission tomography (PET).
Active GCA, either new onset or relapsing, within 8 weeks of Baseline.
Participants must have received treatment with >=40 mg prednisone (or equivalent) at any time prior to Baseline and be receiving prednisone (or equivalent) >= 20 mg once daily (QD) at Baseline.
Participants must have GCA that, in the opinion of the investigator, is clinically stable to allow the participant to safely initiate the protocol-defined corticosteroid (CS) taper regimen.
Females must either be postmenopausal or permanently surgically sterile or, practicing at least 1 specified method of birth control through the study.
Exclusion Criteria:
Prior exposure to any Janus Kinase (JAK) inhibitor.
Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or prior treatment with an IL-6 inhibitor and experienced a disease flare during treatment.
Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start:
Anakinra within 1 week of study start.
Methotrexate, hydroxychloroquine, cyclosporine, azathioprine, or mycophenolate within 4 weeks of study start.
Oral corticosteroid (CS) for conditions other than GCA within 4 week of study start, or intravenous CS within 4 weeks of study start.
Greater than or equal to 8 weeks for leflunomide if no elimination procedure was followed, or adhere to an elimination procedure.
Cell-depleting agents or alkylating agents including cyclophosphamide within 6 months of study start.
Current or past history of infection including herpes zoster or herpes simplex, human immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
Female who is pregnant, breastfeeding, or considering pregnancy during the study.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
ABBVIE INC.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Rheum Assoc of North Alabama /ID# 168668
Huntsville
Alabama
35801
United States
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Those assigned to upadacitinib who achieved sustained remission for at least 24 consecutive weeks prior to Week 52 visit (at the end of Period 1) were re-randomized in a 2:1 ratio to either stay on upadacitinib or switch to placebo in Period 2. Those on placebo who achieved sustained remission for at least 24 weeks prior to Week 52 visit continued on placebo in Period 2.
Recruitment Details
This trial was conducted at 100 sites in 23 countries. Participants were randomized via in a 2:1:1 ratio to receive either upadacitinib 15 mg or 7.5 mg once daily in combination with a predefined 26-week CS taper regimen, or placebo with a predefined 52-week CS taper regimen
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo + 52-week CS Taper
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
At Baseline, all participants switched to corticosteroids (CS) provided by the sponsor with the oral prednisone or prednisolone dose at 20, 30, 40, 50, or 60 mg QD. The initial dose of prednisone or prednisolone was at the discretion of the investigator, based on disease severity and comorbid medical conditions, at a minimum of 20 mg QD at Baseline. At Baseline, if a participant was on a dose other than 20, 30, 40, 50, or 60 mg QD, the dose was rounded up or down, as clinically indicated per investigator discretion, to the nearest of these doses. Prednisone or prednisolone was tapered according to a predefined schedule over a 26- or 52-week period. Open-label prednisone or prednisolone was provided until the dose was tapered to 20 mg/day. Subsequently, blinded prednisone or prednisolone was provided for the remaining blinded taper regimen through Week 52.
15 mg Upadacitinib + 26-week CS taper
7.5 mg Upadacitinib + 26-week CS taper
Placebo + 52-week CS taper
Placebo
Other
Administered orally once a day
15 mg Upadacitinib + 26-week CS taper -> Placebo
7.5 mg Upadacitinib + 26-week CS taper -> Placebo
Placebo + 52-week CS taper
Placebo + 52-week CS taper -> Placebo
Week 12 through Week 52
Cumulative Corticosteroid (CS) Exposure Through Week 52
The cumulative exposure to corticosteroid(s) through Week 52 of the study was documented.
Baseline up to Week 52
Time to First Disease Flare Through Week 52
Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement > 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose.
Baseline up to Week 52
Percentage of Participants Who Experience at Least 1 Disease Flare Through Week 52
The percentage of participants who experience at least 1 disease flare was calculated. Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement > 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose.
Baseline up to Week 52
Percentage of Participants in Complete Remission at Week 52
Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to < 30 mm/hr-- if ESR ≥30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to < 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen.
At Week 52
Percentage of Participants in Complete Remission at Week 24
Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to < 30 mm/hr-- if ESR ≥30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to < 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen.
At Week 24
Change From Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 52
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component summary (PCS) is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from the Baseline score indicates improvement.
Baseline, Week 52
Number of Disease Flares Per Participant Through Week 52
The number of disease flares per participant during Period 1 was documented, and was adjusted by the duration of study participation.
Baseline up to Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Week 52
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, functional fatigue, emotional fatigue, and social consequences of fatigue. 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 items worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Baseline, Week 52
Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale at Week 52
The Treatment Satisfaction Questionnaire for Medications (TSQM) is a generic ePRO measure of treatment satisfaction, developed to compare treatment satisfaction between medication types and conditions. TSQM comprises of 14 items to assess 4 domains (effectiveness, side effects, convenience, and global satisfaction). The TSQM items are rated on a Likert scale (1 = extremely dissatisfied to 7 = extremely satisfied). Scores for each of the 4 domains range from 0 to 100, with higher scores corresponding to higher satisfaction. A positive change from Baseline indicates improvement.
At Week 52
Rate of Corticosteroid-related Adverse Events Though Week 52
The rate of corticosteroid-related adverse events was calculated, and was adjusted by duration of study drug exposure.
Baseline up to Week 52
Glendale
Arizona
85306-9802
United States
VA Long Beach Healthcare System /ID# 203833
Long Beach
California
90822-5201
United States
Robin K. Dore MD, Inc /ID# 201950
Tustin
California
92780
United States
Denver Arthritis Clinic /ID# 171552
Denver
Colorado
80230
United States
Duplicate_Western Connecticut Health Network- Germantown Rd /ID# 205071
Danbury
Connecticut
06810-5038
United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040
Boca Raton
Florida
33486
United States
Lakes Research, LLC /ID# 210442
Miami
Florida
33014
United States
Ctr Arthritis & Rheumatic Dise /ID# 168667
Miami
Florida
33173
United States
Medallion Clinical Research Institute, LLC /ID# 168666
Naples
Florida
34102
United States
Omega Research Group /ID# 201903
Orlando
Florida
32808
United States
IRIS Research and Development, LLC /ID# 169406
Plantation
Florida
33324
United States
Clinical Research of West Florida - Tampa /ID# 201899
Tampa
Florida
33606-1246
United States
Clinical Research of West Florida, Inc /ID# 201901
Tampa
Florida
33606-1246
United States
Duplicate_University of South Florida /ID# 207077
Tampa
Florida
33612-2201
United States
Lovelace Scientific Resources /ID# 169041
Venice
Florida
34292
United States
Arthritis and Rheumatology /ID# 170295
Atlanta
Georgia
30342
United States
Institute of Arthritis Research /ID# 168490
Idaho Falls
Idaho
83404
United States
Duplicate_Rush University Medical Center /ID# 224581
Chicago
Illinois
60612
United States
Ochsner Clinic Foundation /ID# 200723
Baton Rouge
Louisiana
70836-6455
United States
The Arthritis & Diabetes Clinic, Inc. /ID# 171199
Monroe
Louisiana
71203
United States
Ochsner Clinic Foundation-New Orleans /ID# 171200
New Orleans
Louisiana
70121
United States
Louisiana State Univ HSC /ID# 202646
Shreveport
Louisiana
71130
United States
Rheumatology Associates PA - Portland /ID# 225011
Portland
Maine
04102-2643
United States
The Center for Rheumatology and Bone Research /ID# 168652
Wheaton
Maryland
20902
United States
University of Michigan Hospitals /ID# 168645
Ann Arbor
Michigan
48109-5008
United States
Wayne State University Health Center /ID# 212755
Detroit
Michigan
48201-2153
United States
Henry Ford Medical Center - New Center One /ID# 207456
Detroit
Michigan
48202-3046
United States
Duplicate_AA Medical Research Center - Grand Blanc /ID# 201854
Grand Blanc
Michigan
48439
United States
Duplicate_West Michigan Rheumatology /ID# 168647
Grand Rapids
Michigan
49546
United States
Clinvest Research LLC /ID# 208182
Springfield
Missouri
65807
United States
Physician Research Collaboration, LLC /ID# 168610
Lincoln
Nebraska
68516
United States
University Clinical Research Center /ID# 202504
Somerset
New Jersey
08873-3448
United States
University of Rochester Medical Center /ID# 213527
Rochester
New York
14642
United States
Marietta Memorial Hospital /ID# 210834
Marietta
Ohio
45750-1635
United States
STAT Research, Inc. /ID# 200436
Vandalia
Ohio
45377-9464
United States
University of Pennsylvania /ID# 168655
Philadelphia
Pennsylvania
19104-5502
United States
Piedmont Arthritis Clinic, PA /ID# 212431
Greenville
South Carolina
29601
United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761
Summerville
South Carolina
29486-7887
United States
West Tennessee Research Institute /ID# 209256
Jackson
Tennessee
38305
United States
Arthritis Associates of Kingsport /ID# 212756
Kingsport
Tennessee
37660
United States
Allen Arthritis /ID# 225527
Allen
Texas
75013
United States
Tekton Research, L.L.C /ID# 201801
Austin
Texas
78745
United States
Precision Comprehensive Clinical Research Solutions /ID# 201798
Colleyville
Texas
76034
United States
West Texas Clinical Research /ID# 204834
Lubbock
Texas
79424
United States
Arthritis and Rheumatology Institute, PLLC /ID# 214612
Plano
Texas
75093-6419
United States
Baylor Scott & White Center for Diagnostic Medicine /ID# 213529
Temple
Texas
76508
United States
University of Vermont Medical Center /ID# 211179
Burlington
Vermont
05401-1473
United States
Carilion Clinic /ID# 212928
Roanoke
Virginia
24016
United States
Kadlec Clinic Rheumatology /ID# 201618
Kennewick
Washington
99336
United States
University of Washington /ID# 201619
Seattle
Washington
98109
United States
Aurora Rheumatology and Immunotherapy Center /ID# 201853
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946
Nagoya
Aichi-ken
455-8530
Japan
Kagawa University Hospital /ID# 200171
Kita-gun
Kagawa-ken
761-0793
Japan
St. Marianna University Hospital /ID# 218692
Kawasaki-shi
Kanagawa
216-8511
Japan
Duplicate_Japanese Red Cross Kumamoto Hospital /ID# 203507
Kumamoto
Kumamoto
861-8520
Japan
Tohoku University Hospital /ID# 200172
Sendai
Miyagi
9808574
Japan
Okayama University Hospital /ID# 203156
Okayama
Okayama-ken
700-8558
Japan
Tomishiro Central Hospital /ID# 203897
Tomigusuku-shi
Okinawa
901-0243
Japan
Sakai City Medical Center /ID# 202643
Sakai-shi
Osaka
593-8304
Japan
Duplicate_Jichi Medical University Hosp /ID# 200169
Shimotsuke-shi
Tochigi
329-0431
Japan
St.Luke's International Hospital /ID# 200170
Chuo-ku
Tokyo
104-8560
Japan
Radboud Universitair Medisch Centrum /ID# 212925
Nijmegen
Gelderland
6525 GA
Netherlands
Zuyderland Medisch Centrum /ID# 224551
Heerlen
Limburg
6419 PC
Netherlands
ZiekenhuisGroep Twente /ID# 200038
Almelo
Overijssel
7609 PP
Netherlands
Medisch Centrum Leeuwarden /ID# 201716
Leeuwarden
Provincie Friesland
8934 AD
Netherlands
Duplicate_Erasmus Medisch Centrum /ID# 201717
Rotterdam
South Holland
3015 GD
Netherlands
Universitair Medisch Centrum Groningen /ID# 201715
Groningen
9713 GZ
Netherlands
Optimal Clinical Trials Ltd /ID# 201946
Grafotn
Auckland
1010
New Zealand
Aotearoa Clinical Trials /ID# 201942
Papatoetoe
Auckland
2025
New Zealand
Timaru Medical Specialists Ltd /ID# 201943
Timaru
Canterbury
7910
New Zealand
Waikato Hospital /ID# 201944
Hamilton
Waikato Region
3240
New Zealand
CGM Research Trust /ID# 224061
Christchurch Central
8011
New Zealand
Porter Rheumatology Ltd /ID# 223830
Nelson
7010
New Zealand
Drammen Sykehus /ID# 201560
Drammen
Buskerud
3004
Norway
Haukeland universitetssjukehus /ID# 201602
Bergen
Hordaland
5021
Norway
Rikshospitalet OUS HF /ID# 202004
Oslo
0450
Norway
Unidade Local de Saude de Gaia/Espinho, EPE /ID# 208151
Vila Nova de Gaia
Porto District
4434-502
Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186
Ponte de Lima
Viana do Castelo District
4990-041
Portugal
Unidade Local de Saúde da Guarda, EPE /ID# 224878
Guarda
6300-035
Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 203530
Lisbon
1649-035
Portugal
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887
Cluj-Napoca
Cluj
400006
Romania
Cabinet Medical Dr. Avram S.R.L /ID# 224336
Timișoara
TimiÈ™ County
300134
Romania
Spitalul Clinic Sf. Maria /ID# 203809
Bucharest
011172
Romania
Spitalul Clinic Colentina /ID# 204889
Bucharest
020121
Romania
Kemerovo State Medical University /ID# 203676
Kemerovo
Kemerovo Oblast
650056
Russia
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643
Moscow
Moscow Oblast
129110
Russia
Practicheskaya Medicina Clinic /ID# 224612
Moscow
115372
Russia
First Moscow State Medical University n.a I.M. Sechenov /ID# 203673
Moscow
119992
Russia
Euromedservice /ID# 205345
Pushkin
196603
Russia
Clinical Rheumatologic Hospital No 25 /ID# 208950
Saint Petersburg
190068
Russia
Complejo Hospitalario Universitario A Coruña /ID# 224731
A Coruña
A Coruna
15006
Spain
Hospital Universitario Marques de Valdecilla /ID# 201604
Santander
Cantabria
39008
Spain
Hospital Meixoeiro (CHUVI) /ID# 212084
Vigo
Pontevedra
36213
Spain
Hospital Universitario Canarias /ID# 224928
San Cristóbal de La Laguna
Santa Cruz De Tenerife
38320
Spain
Hospital Universitario Basurto /ID# 224730
Bilbao
Vizcaya
48013
Spain
Hospital Clinic de Barcelona /ID# 201878
Barcelona
08036
Spain
Hospital Universitario Virgen de las Nieves /ID# 224726
Granada
18014
Spain
Hospital General Universitario Gregorio Maranon /ID# 201326
Madrid
28007
Spain
Hospital Clinico San Carlos /ID# 204871
Madrid
28040
Spain
Hospital Universitario La Paz /ID# 241848
Madrid
28046
Spain
Skane University hospital /ID# 171407
Malmö
Skåne County
214 28
Sweden
Karolinska University Hospital Solna /ID# 204945
Solna
Stockholm County
171 64
Sweden
Uppsala University Hospital /ID# 171403
Uppsala
Uppsala County
75185
Sweden
Sahlgrenska Universitetssjukhuset /ID# 171405
Gothenburg
Västra Götaland County
413 46
Sweden
Duplicate_Danderyds sjukhus /ID# 171404
Stockholm
182 88
Sweden
Duplicate_Vastmanlands Sjukhus /ID# 171429
Västerås
723 35
Sweden
Universitätsspital Basel /ID# 201767
Basel Town
Canton of Basel-City
4031
Switzerland
Kantonsspital St. Gallen /ID# 201134
Sankt Gallen
Canton of St. Gallen
9007
Switzerland
Inselspital, Universitaetsspital Bern /ID# 201364
Bern
3010
Switzerland
HFR Fribourg - Hôpital cantonal /ID# 201114
Fribourg
1708
Switzerland
Royal United Hospitals Bath /ID# 239850
Bath
Bath And North East Somerset
BA1 3NG
United Kingdom
Royal Devon & Exeter Hospital /ID# 202834
Exeter
Devon
EX2 5DW
United Kingdom
University Hospitals Dorset NHS Foundation Trust /ID# 202836
Poole
Dorset
BH15 2JB
United Kingdom
Barts Health NHS Trust /ID# 210511
London
Greater London
E1 2ES
United Kingdom
UH Coventry & Warwickshire /ID# 202838
Coventry
Warwickshire
CV2 2DX
United Kingdom
Liverpool University University Hospitals NHS Foundation Trust /ID# 240391
Liverpool
L9 7AL
United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 225002
Portsmouth
PO6 3LY
United Kingdom
Southend Hospital /ID# 202839
Southend
SS0 0RY
United Kingdom
Torbay and South Devon Nhs Foundation Trust /Id# 224689
Torquay
TQ2 7AA
United Kingdom
Derived
Loricera J, Tofade T, Prieto-Pena D, Romero-Yuste S, de Miguel E, Riveros-Frutos A, Ferraz-Amaro I, Labrador E, Maiz O, Becerra E, Narvaez J, Galindez-Agirregoikoa E, Gonzalez-Fernandez I, Urruticoechea-Arana A, Ramos-Calvo A, Lopez-Gutierrez F, Castaneda S, Unizony S, Blanco R. Effectiveness of janus kinase inhibitors in relapsing giant cell arteritis in real-world clinical practice and review of the literature. Arthritis Res Ther. 2024 Jun 5;26(1):116. doi: 10.1186/s13075-024-03314-9.
Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
FG002
15 mg Upadacitinib + 26-week CS Taper
Participants randomized to receive 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
FG003
Placebo + 52-week CS Taper -> Placebo
Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR who had absence of GCA signs and symptoms and were CS-free at the Week 52 visit who were randomized to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
Participants randomized to receive 15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
FG007
15 mg Upadacitinib + 26-week CS Taper -> Placebo
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
FG000112 subjects
FG001107 subjects
FG002210 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Randomized
FG000112 subjects
FG001107 subjects
FG002210 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Received Randomized Study Drug
FG000112 subjects
FG001107 subjects
FG002209 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG00086 subjects
FG00185 subjects
FG002177 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG00026 subjects
FG00122 subjects
FG00233 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Adverse Event
FG00013 subjects
FG00111 subjects
FG00217 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Withdrew consent
FG0005 subjects
FG0016 subjects
FG00210 subjects
FG0030 subjects
FG004
COVID-19 logistical restrictions
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Failure to meet continuation criteria
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other, not specified
FG0005 subjects
FG0015 subjects
FG0025 subjects
FG0030 subjects
FG004
Did not receive randomized study drug
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Period 2 (Week 52 - Week 104)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00343 subjects
FG00439 subjects
FG00514 subjects
FG00692 subjects
FG00735 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00338 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
BG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
BG002
15 mg Upadacitinib + 26-week CS Taper
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000112
BG001107
BG002209
BG003428
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
Title
Measurements
BG00071.6± 7.33
BG00171.1± 7.55
BG00270.8± 7.31
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00077
BG00180
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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 Achieving Sustained Remission at Week 52
Sustained remission is defined as having achieved absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52, and adherence to the protocol-defined corticosteroid (CS) taper regimen.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used.
Posted
Number
95% Confidence Interval
percentage of participants
From Week 12 to Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
OG002
15 mg Upadacitinib + 26-week CS Taper
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.
Secondary
Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52
Sustained complete remission is defined as having absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52; normalization of erythrocyte sedimentation rate (ESR); normalization of high sensitivity C-reactive protein (hs-CRP) and adherence to the protocol-defined CS taper regimen.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12 through Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
OG002
15 mg Upadacitinib + 26-week CS Taper
Secondary
Cumulative Corticosteroid (CS) Exposure Through Week 52
The cumulative exposure to corticosteroid(s) through Week 52 of the study was documented.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1. As observed analysis; participants who did not have an evaluation on a scheduled visit were excluded from the analysis for that visit.
Posted
Median
95% Confidence Interval
mg
Baseline up to Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
OG002
15 mg Upadacitinib + 26-week CS Taper
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Secondary
Time to First Disease Flare Through Week 52
Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement > 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1
Posted
Median
95% Confidence Interval
days
Baseline up to Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
OG002
15 mg Upadacitinib + 26-week CS Taper
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Secondary
Percentage of Participants Who Experience at Least 1 Disease Flare Through Week 52
The percentage of participants who experience at least 1 disease flare was calculated. Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement > 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; as observed analysis
Posted
Number
95% Confidence Interval
percentage of participants
Baseline up to Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
OG002
15 mg Upadacitinib + 26-week CS Taper
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Secondary
Percentage of Participants in Complete Remission at Week 52
Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to < 30 mm/hr-- if ESR ≥30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to < 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
OG002
15 mg Upadacitinib + 26-week CS Taper
Secondary
Percentage of Participants in Complete Remission at Week 24
Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to < 30 mm/hr-- if ESR ≥30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to < 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 24
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
OG002
15 mg Upadacitinib + 26-week CS Taper
Secondary
Change From Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 52
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component summary (PCS) is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from the Baseline score indicates improvement.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1 with both Baseline and post-Baseline visit values
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Secondary
Number of Disease Flares Per Participant Through Week 52
The number of disease flares per participant during Period 1 was documented, and was adjusted by the duration of study participation.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; as observed analysis
Posted
Mean
95% Confidence Interval
Disease Flare per Participant per Year
Baseline up to Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
OG002
15 mg Upadacitinib + 26-week CS Taper
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Week 52
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, functional fatigue, emotional fatigue, and social consequences of fatigue. 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 items worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1 with both Baseline and post-Baseline visit values
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Secondary
Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale at Week 52
The Treatment Satisfaction Questionnaire for Medications (TSQM) is a generic ePRO measure of treatment satisfaction, developed to compare treatment satisfaction between medication types and conditions. TSQM comprises of 14 items to assess 4 domains (effectiveness, side effects, convenience, and global satisfaction). The TSQM items are rated on a Likert scale (1 = extremely dissatisfied to 7 = extremely satisfied). Scores for each of the 4 domains range from 0 to 100, with higher scores corresponding to higher satisfaction. A positive change from Baseline indicates improvement.
Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1 with both Baseline and post-Baseline visit values
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
At Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Secondary
Rate of Corticosteroid-related Adverse Events Though Week 52
The rate of corticosteroid-related adverse events was calculated, and was adjusted by duration of study drug exposure.
Safety Analysis Set in Period 1: all participants who received at least 1 dose of study drug in Period 1
Posted
Mean
95% Confidence Interval
CS-related AE per participant per year
Baseline up to Week 52
ID
Title
Description
OG000
Placebo + 52-week CS Taper
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
OG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
OG002
15 mg Upadacitinib + 26-week CS Taper
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Time Frame
All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 364 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 363.5 days for 7.5 mg Upa -> Pbo (Period 2); 364 days for 15 mg Upa -> 15 mg Upa (Period 2); and 364 days for 15 mg Upa -> Pbo (Period 2).
Description
Not provided
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
Placebo + 52-week CS Taper
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
2
112
24
112
90
112
EG001
7.5 mg Upadacitinib + 26-week CS Taper
Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
0
107
14
107
88
107
EG002
15 mg Upadacitinib + 26-week CS Taper
Participants randomized to receive 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
3
210
50
210
174
210
EG003
Placebo + 52-week CS Taper -> Placebo
Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR who had absence of GCA signs and symptoms and were CS-free at the Week 52 visit who were randomized to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
Participants randomized to receive15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
0
92
14
92
67
92
EG007
15 mg Upadacitinib + 26-week CS Taper -> Placebo
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
0
35
5
35
31
35
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG0030 events0 affected43 at risk
EG0040 events0 affected39 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected92 at risk
EG0070 events0 affected35 at risk
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected210 at risk
EG003
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0022 events2 affected210 at risk
EG003
ENDOCARDITIS FIBROPLASTICA
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
MITRAL VALVE INCOMPETENCE
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
MYOCARDIAL ISCHAEMIA
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
TRICUSPID VALVE INCOMPETENCE
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
TOXIC NODULAR GOITRE
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
DIPLOPIA
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
GLAUCOMA
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
MACULAR OEDEMA
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
RETINAL DETACHMENT
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
COLITIS ISCHAEMIC
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
COLITIS ULCERATIVE
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
GASTROINTESTINAL ANGIODYSPLASIA
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
LARGE INTESTINE POLYP
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
MALLORY-WEISS SYNDROME
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PANCREATITIS ACUTE
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events2 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected210 at risk
EG003
DEATH
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
FATIGUE
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
CHOLECYSTITIS CHRONIC
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
HEPATITIS ACUTE
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
ASPERGILLUS INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
COVID-19 PNEUMONIA
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0022 events2 affected210 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
ERYSIPELAS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
FEBRILE INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
GASTROENTERITIS CLOSTRIDIAL
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
GENITOURINARY TRACT INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
INTERVERTEBRAL DISCITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
OPHTHALMIC HERPES ZOSTER
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0023 events3 affected210 at risk
EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected112 at risk
EG0013 events3 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PNEUMONIA BACTERIAL
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PSEUDOMONAL BACTERAEMIA
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
RESPIRATORY SYNCYTIAL VIRUS INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
SALMONELLOSIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
SEPTIC ARTHRITIS STREPTOCOCCAL
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
STAPHYLOCOCCAL SEPSIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
SYSTEMIC BACTERIAL INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
UROSEPSIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
WOUND INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
FOOT FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
HEAD INJURY
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PATELLA FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
RADIUS FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
SPINAL FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
TROPONIN T INCREASED
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0012 events2 affected107 at risk
EG0020 events0 affected210 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
FRACTURE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
LUMBAR SPINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
MENISCAL DEGENERATION
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0022 events2 affected210 at risk
EG003
OSTEONECROSIS OF JAW
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
OSTEOPOROTIC FRACTURE
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
VERTEBRAL FORAMINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
LUNG ADENOCARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
MALIGNANT NEOPLASM OF AMPULLA OF VATER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
MYXOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PAPILLARY THYROID CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PROSTATE CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PROSTATIC ADENOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
SQUAMOUS CELL CARCINOMA OF LUNG
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
SQUAMOUS CELL CARCINOMA OF SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
TONSIL CANCER METASTATIC
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
CEREBELLAR ATAXIA
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
CEREBRAL AMYLOID ANGIOPATHY
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
CEREBRAL INFARCTION
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
CEREBROSPINAL FISTULA
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
QUADRANTANOPIA
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
MAJOR DEPRESSION
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
SUBSTANCE-INDUCED PSYCHOTIC DISORDER
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
CERVICAL DYSPLASIA
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
HAEMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected112 at risk
EG0011 events1 affected107 at risk
EG0025 events5 affected210 at risk
EG003
PULMONARY MASS
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
AORTIC DISSECTION
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
AORTIC THROMBOSIS
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0023 events3 affected210 at risk
EG003
GIANT CELL ARTERITIS
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0011 events1 affected107 at risk
EG0024 events4 affected210 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0022 events1 affected210 at risk
EG003
PERIPHERAL EMBOLISM
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
PERIPHERAL ISCHAEMIA
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CATARACT
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected112 at risk
EG0017 events6 affected107 at risk
EG00210 events10 affected210 at risk
EG0034 events3 affected43 at risk
EG0040 events0 affected39 at risk
EG0051 events1 affected14 at risk
EG0062 events2 affected92 at risk
EG0070 events0 affected35 at risk
OCULAR HYPERAEMIA
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected112 at risk
EG0010 events0 affected107 at risk
EG00213 events11 affected210 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected112 at risk
EG0018 events8 affected107 at risk
EG00211 events11 affected210 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00012 events12 affected112 at risk
EG0016 events5 affected107 at risk
EG00220 events17 affected210 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0006 events4 affected112 at risk
EG0017 events6 affected107 at risk
EG00217 events11 affected210 at risk
EG003
FATIGUE
General disorders
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected112 at risk
EG0014 events4 affected107 at risk
EG00221 events18 affected210 at risk
EG003
MALAISE
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0026 events5 affected210 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 27.1
Systematic Assessment
EG0004 events2 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected112 at risk
EG0018 events7 affected107 at risk
EG00216 events15 affected210 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected112 at risk
EG0010 events0 affected107 at risk
EG0025 events5 affected210 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0029 events8 affected210 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00012 events12 affected112 at risk
EG00112 events12 affected107 at risk
EG00228 events27 affected210 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected112 at risk
EG0015 events5 affected107 at risk
EG00219 events14 affected210 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0013 events3 affected107 at risk
EG0024 events4 affected210 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00015 events14 affected112 at risk
EG0017 events6 affected107 at risk
EG00221 events18 affected210 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0013 events3 affected107 at risk
EG0021 events1 affected210 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0024 events3 affected210 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0012 events2 affected107 at risk
EG0023 events3 affected210 at risk
EG003
TOOTH ABSCESS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0022 events2 affected210 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected112 at risk
EG0014 events3 affected107 at risk
EG0021 events1 affected210 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00010 events8 affected112 at risk
EG0018 events8 affected107 at risk
EG00211 events11 affected210 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00026 events17 affected112 at risk
EG00118 events15 affected107 at risk
EG00225 events21 affected210 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected112 at risk
EG0015 events5 affected107 at risk
EG0028 events7 affected210 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected112 at risk
EG0016 events4 affected107 at risk
EG0027 events7 affected210 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected112 at risk
EG0010 events0 affected107 at risk
EG0022 events2 affected210 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
GLUCOSE URINE PRESENT
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
OCCULT BLOOD POSITIVE
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected112 at risk
EG0016 events6 affected107 at risk
EG0027 events7 affected210 at risk
EG003
DYSLIPIDAEMIA
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0012 events2 affected107 at risk
EG0023 events3 affected210 at risk
EG003
HYPERCHOLESTEROLAEMIA
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0022 events2 affected210 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00016 events15 affected112 at risk
EG0018 events7 affected107 at risk
EG00232 events28 affected210 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00015 events14 affected112 at risk
EG0017 events6 affected107 at risk
EG00228 events25 affected210 at risk
EG003
GREATER TROCHANTERIC PAIN SYNDROME
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected112 at risk
EG0012 events2 affected107 at risk
EG0022 events2 affected210 at risk
EG003
JOINT EFFUSION
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected210 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0008 events8 affected112 at risk
EG0016 events6 affected107 at risk
EG00213 events13 affected210 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected112 at risk
EG0019 events7 affected107 at risk
EG0029 events9 affected210 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected112 at risk
EG0011 events1 affected107 at risk
EG0024 events3 affected210 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected112 at risk
EG0013 events3 affected107 at risk
EG00213 events12 affected210 at risk
EG003
OSTEOPOROSIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected112 at risk
EG0014 events4 affected107 at risk
EG0027 events7 affected210 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected112 at risk
EG0014 events4 affected107 at risk
EG00216 events15 affected210 at risk
EG003
ROTATOR CUFF SYNDROME
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected112 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected210 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected112 at risk
EG0010 events0 affected107 at risk
EG0022 events2 affected210 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected112 at risk
EG0017 events6 affected107 at risk
EG00210 events10 affected210 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG00014 events13 affected112 at risk
EG00123 events16 affected107 at risk
EG00246 events33 affected210 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0010 events0 affected107 at risk
EG0024 events3 affected210 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected112 at risk
EG0014 events4 affected107 at risk
EG0024 events4 affected210 at risk
EG003
BENIGN PROSTATIC HYPERPLASIA
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected210 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected112 at risk
EG0018 events5 affected107 at risk
EG00217 events14 affected210 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0011 events1 affected107 at risk
EG0023 events3 affected210 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected112 at risk
EG0013 events3 affected107 at risk
EG0025 events5 affected210 at risk
EG003
INGROWING NAIL
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected112 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected210 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected112 at risk
EG0010 events0 affected107 at risk
EG0022 events2 affected210 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected112 at risk
EG0013 events3 affected107 at risk
EG00211 events11 affected210 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected210 at risk
EG003
GIANT CELL ARTERITIS
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG00041 events34 affected112 at risk
EG00135 events27 affected107 at risk
EG00257 events45 affected210 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG00013 events13 affected112 at risk
EG00117 events16 affected107 at risk
EG00231 events28 affected210 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.
Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.
Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.
P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).
P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).
Units
Counts
Participants
OG000112
OG001107
OG002209
Title
Denominators
Categories
Title
Measurements
OG000323.0(249.00 to NA)Not calculable/estimable due to low number of participants with events
OG001NA(316.00 to NA)Not calculable/estimable due to low number of participants with events
OG002NA(NA to NA)Not calculable/estimable due to low number of participants with events
Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates
Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates
This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.
=0.0014
Odds Ratio (OR)
0.47
2-Sided
95
0.29
0.74
Superiority
The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.
This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.
=0.0633
Odds Ratio (OR)
0.60
2-Sided
95
0.35
1.03
Superiority
The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.
Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.
Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone > 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
OG002
15 mg Upadacitinib + 26-week CS Taper
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone >30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.
The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone >30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.
Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.
Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.
OG002
15 mg Upadacitinib + 26-week CS Taper
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone >30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.
The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone >30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.
OG002
15 mg Upadacitinib + 26-week CS Taper
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone >30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.
The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone >30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.
Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.
Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.