A Study to Evaluate the Safety and Efficacy of Upadacitin... | NCT02819635 | Trialant
NCT02819635
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jun 30, 2022Actual
Enrollment
1,302Actual
Phase
Phase 2Phase 3
Conditions
Ulcerative Colitis (UC)
Interventions
Placebo
Upadacitinib
Countries
United States
Argentina
Australia
Austria
Belarus
Belgium
Bosnia and Herzegovina
Brazil
Canada
Chile
China
Colombia
Croatia
Czechia
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Israel
Italy
Japan
Latvia
Lithuania
Malaysia
Mexico
Netherlands
Norway
Poland
Portugal
Puerto Rico
Russia
Serbia
Singapore
Slovakia
South Africa
South Korea
Spain
Sweden
Switzerland
Taiwan
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02819635
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M14-234
Secondary IDs
ID
Type
Description
Link
2016-000641-31
EudraCT Number
Brief Title
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jun 2022
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
Sep 26, 2016Actual
Primary Completion Date
Dec 13, 2021Actual
Completion Date
Dec 13, 2021Actual
First Submitted Date
Jun 28, 2016
First Submission Date that Met QC Criteria
Jun 28, 2016
First Posted Date
Jun 30, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 3, 2022
Results First Submitted that Met QC Criteria
Jun 3, 2022
Results First Posted Date
Jun 30, 2022Actual
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
Jun 3, 2022
Last Update Posted Date
Jun 30, 2022Actual
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 was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
Detailed Description
Substudy 1 was a Phase 2b dose-ranging study designed to evaluate the efficacy and safety of different oral doses of upadacitinib compared to placebo as 8-week induction therapy in participants with moderately to severely active UC. Approximately 250 participants were planned to be randomized 1:1:1:1:1 to the placebo group and 4 upadacitinib doses (7.5, 15, 30, and 45 mg). Randomization was stratified by previous biologic therapy use (yes/no), Baseline corticosteroid use (yes/no), and Baseline Adapted Mayo score (≤ 7 or > 7). The study duration included a Screening Period of up to 5 weeks and an 8-week double-blind (DB) Induction Period. After all randomized participants completed the 8-week induction, a dose-selection analysis of efficacy and safety (selected laboratory parameters) of upadacitinib versus placebo was performed. Based on this dose-selection analysis, one induction dose (upadacitinib 45 mg) was identified for further evaluation in two Phase 3 induction studies, M14-234 Substudy 2 and M14-675 (NCT03653026). During the analysis period, 132 additional participants were randomized into Groups 3 and 4 of Substudy 1 (upadacitinib 30 mg and 45 mg dose groups; approximately 66 participants per dose group). The objectives of enrolling these additional participants were to avoid interrupting the study activities during the analysis period and to support a sufficient number of participants with clinical response to be re-randomized into the maintenance portion in Substudy 3. Substudy 1 main participants are defined as those first 250 randomized 250, and additional participants are defined as those who were randomized after the main participants.
Substudy 2 was a two-part Phase 3 dose-confirming study designed to evaluate the efficacy and safety of oral administration of upadacitinib 45 mg compared to placebo as induction therapy for up to 16 weeks in participants with moderately to severely active UC. Substudy 2 included a Screening Period of up to 5 weeks, Part 1, and Part 2. Part 1 was a randomized, DB, placebo-controlled 8-week induction period. Part 2 was an open-label, 8-week extended treatment period for clinical non-responders from Part 1 of Substudy 2. Part 1 was planned to enroll 462 subjects; actual enrollment was 474 subjects. Eligible participants were randomized in a 2:1 ratio to one of the two treatment groups (DB upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization was stratified by bio-IR status (Biologic inadequate responders [bio-IR] vs Non-biologic-inadequate responders [non-bio-IR], corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or > 7) at Baseline. Within bio-IR, the randomization was further stratified by number of prior biologic treatments (≤ 1 or > 1). Within non-bio-IR, the randomization was further stratified by previous biologic use (yes or no). Part 2 was an open label, 8-week Extended Treatment Period for those who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1. All participants received upadacitinib 45 mg.
Substudy 3 was a Phase 3 maintenance study designed to evaluate the efficacy and safety of upadacitinib 15 and 30 mg once daily (QD) compared to placebo in achieving clinical remission per Adapted Mayo score in participants with moderately to severely active UC who achieved clinical response per Adapted Mayo score following induction therapy from Substudy 1, Substudy 2, or Study M14-675. A total of 1,046 subjects who achieved clinical response per Adapted Mayo score after completion of induction treatment or Extended Treatment Period in Study M14-234 Substudy 1, Substudy 2, or Study M14-675 entered Substudy 3, and 1,044 were treated with a blinded treatment assignment for up to 52 weeks. Substudy 3 included 4 cohorts. Cohort 1: 847 participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, and received upadacitinib 15, 30, or 45 mg QD. The treatment groups in Cohort 1 were Group 1: upadacitinib 15 mg QD; Group 2: upadacitinib 30 mg QD; and Group 3: placebo QD. Those who achieved clinical response and received upadacitinib 15 mg QD in Substudy 1 were re-randomized 1:1 to only receive upadacitinib 15 mg QD or placebo QD (treatment Group 1 or 3). Cohort 2: 104 participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3. Cohort 3: 75 participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 were re-randomized 1:1 and received blinded upadacitinib 30 mg QD or upadacitinib 15 mg QD in Substudy 3. Cohort 4: 20 participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3.
Conditions Module
Conditions
Ulcerative Colitis (UC)
Keywords
Upadacitinib (ABT-494)
Moderately to Severely Active UC
RINVOQ
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,302Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
SS1: Placebo
Placebo Comparator
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Drug: Placebo
SS1: Upadacitinib 7.5 mg
Experimental
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Drug: Upadacitinib
SS1: Upadacitinib 15 mg
Experimental
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Drug: Upadacitinib
SS1: Upadacitinib 30 mg
Experimental
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Drug: Upadacitinib
SS1: Upadacitinib 45 mg
Experimental
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Film-coated tablet for oral administration
SS1: Placebo
SS2: Placebo/Upadacitinib 45 mg
SS3: M14-675 clinical responders
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1.
At Week 8
Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 2, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
At Week 8
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Secondary Outcomes
Measure
Description
Time Frame
Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Note: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants ≥18 years old will be enrolled. Adolescents must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.
Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator.
Note: Participants who have had inadequate response, loss of response to conventional therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease) and must meet criteria for inadequate response, loss of response or intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.
If female, participant must meet the criteria for Contraception Recommendations
Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.
Exclusion Criteria:
Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC)
Current diagnosis of fulminant colitis and/or toxic megacolon
Participant with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy
Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline
Participant on azathioprine or 6-mercaptopurine within 10 days of Baseline
Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
Screening laboratory and other analyses show any abnormal results meeting the exclusion criteria
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
For details on when studies are available for sharing, please refer to the link below.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Intent-to-treat (ITT) analysis set: Substudy 1 (all randomized participants who received at least one dose of study drug in Substudy 1); Substudy 2 (all randomized participants who received at least one dose of doubleblinded study drug in Part 1 and all participants who received at least one dose of upadacitinib 45 mg in Part 2); Substudy 3 (all participants who received at least one dose of study drug in Substudy 3)
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
Drug: Placebo
Drug: Upadacitinib
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
Experimental
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
Drug: Upadacitinib
SS3: M14-675 clinical responders
Experimental
Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were re-randomized and treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth [QD], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
Drug: Placebo
Drug: Upadacitinib
Upadacitinib
Drug
Film-coated tablet for oral administration
SS1: Upadacitinib 15 mg
SS1: Upadacitinib 30 mg
SS1: Upadacitinib 45 mg
SS1: Upadacitinib 7.5 mg
SS2: Placebo/Upadacitinib 45 mg
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
SS3: M14-675 clinical responders
ABT-494
RINVOQ
At Week 52
At Week 8
Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
At Week 8
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
At Week 8
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
At Week 2
Substudy 1: Change in Full Mayo Score From Baseline to Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Baseline (Week 0), Week 8
Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
At Week 8
Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Histologic improvement was defined as decrease from baseline in Geboes score.
At Week 8
Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
At Week 8
Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
At Week 8
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
At Week 8
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical response per Partial Mayo Score is defined as a decrease from Baseline ≥ 1 point and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
At Week 2
Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.
The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
At Week 8
Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8
Bowel urgency was assessed by participants in a subject diary completed once a day.
At Week 8
Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8
Abdominal pain was assessed by participants in a subject diary completed once a day.
At Week 8
Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. Histologic improvement was defined as decrease from baseline in Geboes score.
At Week 8
Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Baseline (Week 0), Week 8
Substudy 2: Percentage Of Participants With Mucosal Healing at Week 8
Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
At Week 8
Substudy 2: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8
The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.
Baseline (Week 0), Week 8
Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
At Week 52
Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
At Week 52
Substudy 3: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Wk 52 and Were Corticosteroid Free for ≥ 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
At Week 52
Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
At Week 52
Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
At Week 52
Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
At Week 52
Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52
Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.
The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
At Week 52
Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Baseline (Week 0), Week 52
Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52
Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
At Week 52
Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52
Bowel urgency was assessed by participants in a subject diary completed once a day.
At Week 52
Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52
Abdominal pain was assessed by participants in a subject diary completed once a day.
At Week 52
Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52
The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.
Baseline (Week 0), Week 52
Mobile
Alabama
36606
United States
CB Flock Research Corporation /ID# 165980
Mobile
Alabama
36608
United States
Delsol Research Management, Ll /Id# 170131
Chandler
Arizona
85224
United States
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885
Pauls Stradins Clinical University Hospital /ID# 151409
Riga
1002
Latvia
Riga East Clinical University Hospital /ID# 150354
Riga
LV-1079
Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150357
Kaunas
50161
Lithuania
Klaipeda Seamens Hospital /ID# 154319
Klaipėda
92288
Lithuania
Klaipeda University Hospital /ID# 158862
Klaipėda
92288
Lithuania
Vilnius University Hospital /ID# 154318
Vilnius
LT-08661
Lithuania
Hospital Sultanah Bahiyah /ID# 151687
Alor Star
Kedah
05460
Malaysia
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 151689
Kuala Lumpur
Selangor
56000
Malaysia
Hospital Ampang /ID# 151298
Ampang
68000
Malaysia
Uni Malaya MC /ID# 150359
Kuala Lumpur
59100
Malaysia
Morales Vargas Centro de Investigacion S.C. /ID# 211325
León
Guanajuato
37000
Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 150710
Guadalajara
Jalisco
44650
Mexico
Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150256
Monterrey
Nuevo León
64610
Mexico
Radboud Universitair Medisch Centrum /ID# 151700
Nijmegen
Gelderland
6525 GA
Netherlands
Erasmus Medisch Centrum /ID# 150308
Rotterdam
South Holland
3015 GD
Netherlands
Academisch Medisch Centrum /ID# 150647
Amsterdam
1105 AZ
Netherlands
Leids Universitair Medisch Centrum /ID# 152624
Leiden
2333 ZA
Netherlands
Universitair Medisch Centrum Utrecht /ID# 152775
Utrecht
3584 CX
Netherlands
Akershus universitetssykehus /ID# 150317
Nordbyhagen
Akershus
1474
Norway
Universitetssykehuset Nord-Norge /ID# 152835
Tromsø
Troms
9019
Norway
Gastromed /Id# 216197
Torun
Kuyavian-Pomeranian Voivodeship
87-100
Poland
Centrum Zdrowia MDM /ID# 150351
Warsaw
Masovian Voivodeship
00-635
Poland
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 150580
Warsaw
Masovian Voivodeship
02-507
Poland
Centrum Medyczne Reuma Park /ID# 150349
Warsaw
Masovian Voivodeship
02-665
Poland
NZOZ Vivamed /ID# 216742
Warsaw
Masovian Voivodeship
03-580
Poland
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215732
Warsaw
Masovian Voivodeship
04-730
Poland
Endoskopia Sp. z o.o. /ID# 150765
Sopot
Pomeranian Voivodeship
81-756
Poland
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151607
Guimarães
Braga District
4835-044
Portugal
Centro Hospitalar de Entre Douro e Vouga /ID# 152335
Santa Maria DA Feira
Porto District
4520-211
Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151609
Ponte de Lima
Viana do Castelo District
4990-041
Portugal
Hospital Garcia de Orta, EPE /ID# 151613
Almada
2805-267
Portugal
CCA Braga - Hospital de Braga /ID# 151608
Braga
4710-243
Portugal
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 151611
Lisbon
1169-050
Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151606
Lisbon
1649-035
Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151610
Porto
4200-319
Portugal
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150358
San Juan
00935
Puerto Rico
Immanuel Kant Baltic Federal University /ID# 200719
Kaliningrad
Kaliningrad Oblast
236016
Russia
NW State Medical Univ na Mechn /ID# 169322
Saint Petersburg
Leningradskaya Oblast'
191015
Russia
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150386
Perm
Permskiy Kray
614109
Russia
Medical Company Hepatolog /ID# 200197
Samara
Samara Oblast
443063
Russia
LLC Novaya Klinika /ID# 208107
Pyatigorsk
Stavropol Kray
357500
Russia
Kazan State Medical University /ID# 166042
Kazan'
Tatarstan, Respublika
420012
Russia
Olla-Med Clinic /ID# 215332
Moscow
105554
Russia
City Clinical Hospital #24 /ID# 150395
Moscow
127015
Russia
Republican hospital named after V.A. Baranov /ID# 206506
Petrozavodsk
185019
Russia
Euromedservice /ID# 203800
Pushkin
196603
Russia
Duplicate_Stavropol State Medical Univ /ID# 150387
Stavropol
355017
Russia
Clinical Hosp Center Zvezdara /ID# 150427
Belgrade
Beograd
11000
Serbia
Military Medical Academy /ID# 150429
Belgrade
Beograd
11000
Serbia
University Clinical Center Serbia /ID# 150428
Belgrade
Beograd
11000
Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 150426
Belgrade
Beograd
11080
Serbia
University Clinical Center of Nis /ID# 151903
Niš
Nisavski Okrug
18000
Serbia
University Clinical Center Kragujevac /ID# 150430
Kragujevac
Sumadijski Okrug
34000
Serbia
Clinical Center Vojvodina /ID# 150764
Novi Sad
Vojvodina
21000
Serbia
General Hospital Leskovac /ID# 217880
Leskovac
16000
Serbia
National University Hospital /ID# 150453
Singapore
119074
Singapore
Gleneagles Medical Centre /ID# 206018
Singapore
258499
Singapore
Tan Tock Seng Hospital /ID# 150443
Singapore
308433
Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150868
Banská Bystrica
975 17
Slovakia
Medak s.r.o. /ID# 150480
Bratislava
851 01
Slovakia
Slovak Research Center Team Me /ID# 150257
Ilava
019 01
Slovakia
B+B MED, s.r.o. /ID# 150471
Košice
040 01
Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211370
Nové Zámky
940 34
Slovakia
GASTRO I., s.r.o. /ID# 150472
Prešov
080 01
Slovakia
MD Search /ID# 167293
Boksburg North
Gauteng
1460
South Africa
Clinresco Centers /ID# 163622
Johannesburg
Gauteng
1619
South Africa
Lenasia Clinical Trial Centre /ID# 214344
Johannesburg
Gauteng
1820
South Africa
Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 150785
Johannesburg
Gauteng
2193
South Africa
Wits Clinical Research Site /ID# 150496
Johannesburg
Gauteng
2193
South Africa
Kingsbury Hospital /ID# 150497
Cape Town
Western Cape
7708
South Africa
Private Practice Dr MN Rajabally /ID# 155144
Cape Town
Western Cape
7800
South Africa
Spoke Research Inc /ID# 162202
CAPE TOWN Milnerton
Western Cape
7441
South Africa
Hayang University GuriHospital /ID# 150344
Guri-si
Gyeonggido
11923
South Korea
CHA University Bundang Medical Center /ID# 159479
Seongnam-si
Gyeonggido
13496
South Korea
The Catholic University of Korea, ST. Vincent's Hospital /ID# 150347
Suwon
Gyeonggido
16247
South Korea
Kangbuk Samsung Hospital /ID# 150348
Seoul
Seoul Teugbyeolsi
03181
South Korea
Yonsei University Health System Severance Hospital /ID# 159478
Seoul
Seoul Teugbyeolsi
03722
South Korea
Dong-A University Hospital /ID# 159480
Busan
49201
South Korea
Pusan National University Hospital /ID# 159481
Busan
49241
South Korea
Yeungnam University Medical Center /ID# 150345
Daegu
42415
South Korea
Asan Medical Center /ID# 150900
Seoul
05505
South Korea
Samsung Medical Center /ID# 150346
Seoul
06351
South Korea
Hospital Clínico Universitario de Santiago-CHUS /ID# 151065
Santiago de Compostela
A Coruna
15706
Spain
Hospital Unversitario Marques de Valdecilla /ID# 216620
Santander
Cantabria
39008
Spain
Hospital Universitario Dr. Negrin /ID# 203937
Las Palmas de Gran Canaria
Las Palmas
35019
Spain
Hospital Universitario A Coruna - CHUAC /ID# 203911
A Coruña
15006
Spain
Hospital Clinic de Barcelona /ID# 150612
Barcelona
08036
Spain
Hospital Universitario Reina Sofia /ID# 151066
Córdoba
14004
Spain
Hospital Universitario Ramon y Cajal /ID# 151067
Madrid
28034
Spain
Hospital Universitario La Paz /ID# 214539
Madrid
28046
Spain
Hospital Universitario de Salamanca /ID# 150509
Salamanca
37711
Spain
Hospital Universitario y Politecnico La Fe /ID# 150611
Valencia
46026
Spain
Sahlgrenska University Hospital /ID# 151496
Gothenburg
Västra Götaland County
413 45
Sweden
Universitätsspital Basel /ID# 161731
Basel
Canton of Basel-City
4031
Switzerland
Kantonsspital St. Gallen /ID# 152599
Sankt Gallen
Canton of St. Gallen
9007
Switzerland
Universitätsspital Zürich /ID# 152591
Zurich
Canton of Zurich
8091
Switzerland
Inselspital, Universitätsspital Bern /ID# 152590
Bern
3010
Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150575
Kaohsiung City
807
Taiwan
Chung Shan Medical University Hospital /ID# 150573
Taichung
40201
Taiwan
China Medical University Hospital /ID# 150571
Taichung
40447
Taiwan
National Cheng Kung University Hospital /ID# 151749
Tainan
704
Taiwan
National Taiwan University Hospital /ID# 150574
Taipei
100
Taiwan
Taipei Veterans General Hosp /ID# 151748
Taipei
11217
Taiwan
Erciyes University Medical Fac /ID# 150129
Melikgazi
Kayseri
38030
Turkey (Türkiye)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 150125
Istanbul
34098
Turkey (Türkiye)
Umraniye Training and Res Hosp /ID# 162659
Istanbul
34764
Turkey (Türkiye)
Marmara University Medical Fac /ID# 213969
Istanbul
34899
Turkey (Türkiye)
Mersin University Medical /ID# 157849
Mersin
33343
Turkey (Türkiye)
Gazi Universitesi Tip Fakultes /ID# 150127
Yenimahalle
06560
Turkey (Türkiye)
Medical Center of the "Health /ID# 151274
Vinnytsia
Vinnytsia Oblast
21009
Ukraine
Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207723
Dnipro
49005
Ukraine
CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206940
Kharkiv
61058
Ukraine
PE PMC Acinus, Medical and Diagnostic Center /ID# 217216
Kropyvnytskyi
25006
Ukraine
Kyiv Municipal Clinical Hospital #18 /ID# 150372
Kyiv
01030
Ukraine
Medical Center CONSILIUM MEDICAL /ID# 217446
Kyiv
04050
Ukraine
CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217372
Kyiv
04073
Ukraine
Lviv Regional Clinical Hospital /ID# 150375
Lviv
79010
Ukraine
Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 151275
Odesa
65025
Ukraine
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216297
Vinnytsia
21028
Ukraine
Royal Devon and Exeter NHS Trust Hospital /ID# 150379
Exeter
Devon
EX2 5DW
United Kingdom
Hampshire Hospitals NHS Foundation Trust /ID# 150380
Basingstoke
Essex
RG24 9NA
United Kingdom
Barts Health NHS Trust /ID# 150384
London
London, City of
E1 2ES
United Kingdom
NHS Greater Glasgow and Clyde /ID# 163787
Glasgow
Scotland
G12 0XH
United Kingdom
Royal United Hospitals Bath /ID# 151532
Bath
BA1 3NG
United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 150382
Birmingham
B15 2TH
United Kingdom
Calderdale and Huddersfield NHS Foundation Trust /ID# 217658
Huddersfield
HX3 0PW
United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 208374
Tooting
SW17 0QT
United Kingdom
Derived
Panes J, Dubinsky MC, Ishiguro Y, Shukla N, Dubcenco E, Remple V, Sharma D, Panaccione R. Achievement of long-term treatment goals in upadacitinib-treated patients with moderately to severely active ulcerative colitis: a post hoc analysis of phase 3 trial data. J Crohns Colitis. 2025 Jul 3;19(7):jjaf095. doi: 10.1093/ecco-jcc/jjaf095.
Panaccione R, Danese S, Zhou W, Klaff J, Ilo D, Yao X, Levy G, Higgins PDR, Loftus EV Jr, Chen S, Gonzalez YS, Leonard C, Hebuterne X, Lindsay JO, Cao Q, Nakase H, Colombel JF, Vermeire S. Efficacy and safety of upadacitinib for 16-week extended induction and 52-week maintenance therapy in patients with moderately to severely active ulcerative colitis. Aliment Pharmacol Ther. 2024 Feb;59(3):393-408. doi: 10.1111/apt.17816. Epub 2023 Nov 27.
Raine T, Ishiguro Y, Rubin DT, Finney-Hayward T, Vladea R, Liu J, Phillips C, Cheng E, Targownik L, Loftus EV Jr. Impact of Baseline Corticosteroid Use on the Efficacy and Safety of Upadacitinib in Patients with Ulcerative Colitis: A Post Hoc Analysis of the Phase 3 Clinical Trial Programme. J Crohns Colitis. 2024 May 31;18(5):695-707. doi: 10.1093/ecco-jcc/jjad190.
Vermeire S, Danese S, Zhou W, Ilo D, Klaff J, Levy G, Yao X, Chen S, Sanchez Gonzalez Y, Hebuterne X, Lindsay JO, Higgins PDR, Cao Q, Nakase H, Colombel JF, Loftus EV Jr, Panaccione R. Efficacy and safety of upadacitinib maintenance therapy for moderately to severely active ulcerative colitis in patients responding to 8 week induction therapy (U-ACHIEVE Maintenance): overall results from the randomised, placebo-controlled, double-blind, phase 3 maintenance study. Lancet Gastroenterol Hepatol. 2023 Nov;8(11):976-989. doi: 10.1016/S2468-1253(23)00208-X. Epub 2023 Sep 9.
Loftus EV Jr, Ananthakrishnan AN, Lee WJ, Gonzalez YS, Fitzgerald KA, Wallace K, Zhou W, Litcher-Kelly L, Ollis SB, Su S, Danese S. Content Validity and Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Patients with Crohn's Disease and Ulcerative Colitis. Pharmacoecon Open. 2023 Sep;7(5):823-840. doi: 10.1007/s41669-023-00419-w. Epub 2023 Jun 9.
Danese S, Tran J, D'Haens G, Rubin DT, Aoyama N, Zhou W, Ilo D, Yao X, Sanchez Gonzalez Y, Panaccione R. Upadacitinib Induction and Maintenance Therapy Improves Abdominal Pain, Bowel Urgency, and Fatigue in Patients With Ulcerative Colitis: A Post Hoc Analysis of Phase 3 Data. Inflamm Bowel Dis. 2023 Nov 2;29(11):1723-1729. doi: 10.1093/ibd/izad016.
Panes J, Loftus EV, Higgins PDR, Lindsay JO, Zhou W, Yao X, Ilo D, Phillips C, Tran J, Sanchez Gonzalez Y, Vermeire S. Induction and Maintenance Treatment With Upadacitinib Improves Health-Related Quality of Life in Patients With Moderately to Severely Active Ulcerative Colitis: Phase 3 Study Results. Inflamm Bowel Dis. 2023 Sep 1;29(9):1421-1430. doi: 10.1093/ibd/izac260.
Loftus EV Jr, Colombel JF, Takeuchi K, Gao X, Panaccione R, Danese S, Dubinsky M, Schreiber S, Ilo D, Finney-Hayward T, Zhou W, Phillips C, Gonzalez YS, Shu L, Yao X, Zhou Q, Vermeire S. Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1 of Induction Treatment. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2347-2358.e6. doi: 10.1016/j.cgh.2022.11.029. Epub 2022 Dec 1.
Sandborn WJ, Ghosh S, Panes J, Schreiber S, D'Haens G, Tanida S, Siffledeen J, Enejosa J, Zhou W, Othman AA, Huang B, Higgins PDR. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020 Jun;158(8):2139-2149.e14. doi: 10.1053/j.gastro.2020.02.030. Epub 2020 Feb 22.
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
FG002
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
FG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
FG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
FG005
SS2: Placebo/Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
FG006
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
FG007
SS3: M14-675 Clinical Responders
Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth [QD], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
FG008
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
FG009
SS3: UPA 7.5 mg
Participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3 for up to 52 weeks.
FG010
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 15 mg QD in Substudy 3.
FG011
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 30 mg QD in Substudy 3.
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FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG00041 subjects
FG00145 subjects
FG00245 subjects
FG003105 subjects
FG004113 subjects
FG005135 subjects
FG006306 subjects
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FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0005 subjects
FG0012 subjects
FG0024 subjects
FG00312 subjects
FG00410 subjects
FG00520 subjects
FG00613 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0011 subjects
FG0023 subjects
FG0035 subjects
FG0044 subjects
FG0059 subjects
FG0066 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Withdrew consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COVID-19 Logistical Restrictions
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other, not specified
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0037 subjects
FG004
Substudy 2, Part 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00585 subjects
FG00659 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Substudy 3
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008386 subjects
FG00920 subjects
FG010324 subjects
FG011316 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Intent-to-treat (ITT) analysis set: Substudy 1 (all randomized participants who received at least one dose of study drug in Substudy 1); Substudy 2 (all randomized participants who received at least one dose of doubleblinded study drug in Part 1 and all participants who received at least one dose of upadacitinib 45 mg in Part 2); Substudy 3 (all M14-675 participants who received at least one dose of study drug in Substudy 3)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
BG001
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
BG002
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
BG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
BG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
BG005
SS2: Placebo/Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
BG006
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
BG007
SS3: M14-675 Clinical Responders
Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth [QD], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00046
BG00147
BG00249
BG003117
BG004123
BG005155
BG006319
BG007446
BG0081302
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
ParticipantsBG00046
ParticipantsBG00147
ParticipantsBG00249
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00046
ParticipantsBG00147
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
White
ParticipantsBG00046
ParticipantsBG00147
ParticipantsBG002
Average Stool Frequency Subscore
Participants recorded stool frequency using an electronic subject diary on a daily basis. The stool frequency subscore (SFS) ranges from 0 to 3 according to the following scale:
Score 0: Normal number of stools
Score 1: 1 to 2 stools more than normal
Score 2: 3 to 4 stools more than normal
Score 3: 5 or more stools more than normal
Participants with available data
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG00046
ParticipantsBG00147
Average Rectal Bleeding Subscore
Participants recorded rectal bleeding in an electronic subject diary on a daily basis. The rectal bleeding subscore ranges from 0 to 3 according to the following scale:
Score 0: No blood seen
Score 1: Streaks of blood with stool less than half the time
Score 2: Obvious blood with stool most of the time
Score 3: Blood alone passed
Participants with available data
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG00046
ParticipantsBG00147
Average Endoscopy Subscore
Findings on endoscopy were scored according to the following:
Score 2: Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions)
Score 3: Severe disease (spontaneous bleeding, ulceration)
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG00046
ParticipantsBG00147
ParticipantsBG002
Previous Biologic Use
Participants with available data
Count of Participants
Participants
No
Title
Denominators
Categories
Yes
ParticipantsBG00046
ParticipantsBG00147
ParticipantsBG002
Biologic-inadequate Responder (Bio-IR) Status
Biologic-inadequate responders (Bio-IR) are defined as participants who had inadequate response, loss of response, or intolerance to biologic therapy.
Non-biologic-inadequate responders (non-bio-IR) are defined as participants who had inadequate response, loss of response, or intolerance to conventional therapy but had not failed biologic therapy.
Participants with available data
Count of Participants
Participants
No
Title
Denominators
Categories
Bio-IR
ParticipantsBG0000
ParticipantsBG0010
Baseline Corticosteroid Use
Count of Participants
Participants
No
Title
Denominators
Categories
Yes
ParticipantsBG00046
ParticipantsBG00147
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1.
SS1 main population (ITT1A): those randomized to ≥1 dose of study drug during the initial part of SS1. Non-responder imputation (NRI) was used to impute missing values.
Posted
Number
percentage of participants
At Week 8
ID
Title
Description
OG000
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG002
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
OG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Units
Counts
Participants
OG00046
OG00147
OG00249
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0018.5
OG00214.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 1: Upadacitinib 7.5 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.049
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
8.4
2-Sided
95
0.0
16.8
Difference = Upadacitinib 7.5 mg - Placebo
Primary
Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 2, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
SS2, Part 1 population (ITT1): all randomized participants in the 8-week double-blind induction period who received ≥1 dose of study drug. NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used for SS2, with participants analyzed according to treatment groups to which they were randomized.
Posted
Number
percentage of participants
At Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
Primary
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
Secondary
Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
Posted
Number
percentage of participants
At Week 8
ID
Title
Description
OG000
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG002
SS1: Upadacitinib 15 mg
Secondary
Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
Posted
Number
percentage of participants
At Week 8
ID
Title
Description
OG000
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG002
Secondary
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
Posted
Number
percentage of participants
At Week 8
ID
Title
Description
OG000
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Secondary
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
Posted
Number
percentage of participants
At Week 2
ID
Title
Description
OG000
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Secondary
Substudy 1: Change in Full Mayo Score From Baseline to Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Last observation carried forward (LOCF) was used for missing data.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 0), Week 8
ID
Title
Description
OG000
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG002
Secondary
Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
Posted
Number
percentage of participants
At Week 8
ID
Title
Description
OG000
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG002
SS1: Upadacitinib 15 mg
Secondary
Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Histologic improvement was defined as decrease from baseline in Geboes score.
The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
Posted
Number
percentage of participants
At Week 8
ID
Title
Description
OG000
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Secondary
Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Secondary
Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Secondary
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
Secondary
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical response per Partial Mayo Score is defined as a decrease from Baseline ≥ 1 point and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 2
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Secondary
Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.
The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
Secondary
Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8
Bowel urgency was assessed by participants in a subject diary completed once a day.
The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Units
Counts
Participants
Secondary
Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8
Abdominal pain was assessed by participants in a subject diary completed once a day.
The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Units
Counts
Participants
Secondary
Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. Histologic improvement was defined as decrease from baseline in Geboes score.
The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Secondary
Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
The Substudy 2, Part 1 ITT1 population with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases up to Week 8 was used except for measurements at or after the occurrence of UC-related corticosteroids intercurrent event were excluded
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline (Week 0), Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Secondary
Substudy 2: Percentage Of Participants With Mucosal Healing at Week 8
Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
Secondary
Substudy 2: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8
The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.
The Substudy 2, Part 1 ITT1 population with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases up to Week 8 was used except for measurements at or after the occurrence of UC-related corticosteroids intercurrent event were excluded
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline (Week 0), Week 8
ID
Title
Description
OG000
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG001
SS2: Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Secondary
Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
Secondary
Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved clinical remission per Adapted Mayo Score in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
Secondary
Substudy 3: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Wk 52 and Were Corticosteroid Free for ≥ 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved clinical remission per Adapted Mayo Score in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
Secondary
Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved endoscopic improvement in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
OG001
Secondary
Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
Secondary
Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved clinical response per Adapted Mayo Score in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
Secondary
Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52
Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.
The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
Secondary
Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Substudy 3 ITT_A population with available data: Baseline is defined as the last non-missing value prior to the first dose in Phase 2b Induction or Induction Studies. Multiple Imputation Incorporating Return-to-Baseline (RTB-MI) was used to handle missing data.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline (Week 0), Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
OG001
SS3: UPA 15 mg
Secondary
Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52
Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
Secondary
Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52
Bowel urgency was assessed by participants in a subject diary completed once a day.
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks.
OG002
Secondary
Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52
Abdominal pain was assessed by participants in a subject diary completed once a day.
Substudy 3 ITT_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Posted
Number
95% Confidence Interval
percentage of participants
At Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
OG002
Secondary
Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52
The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.
Substudy 3 ITT_A population with available data: Baseline is defined as the last non-missing value prior to the first dose in Phase 2b Induction or Induction Studies. Multiple Imputation Incorporating Return-to-Baseline (RTB-MI) was used to handle missing data.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline (Week 0), Week 52
ID
Title
Description
OG000
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
Time Frame
All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
Description
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
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
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
0
46
5
46
27
46
EG001
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
0
47
0
47
18
47
EG002
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
0
49
2
49
22
49
EG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
0
117
5
117
58
117
EG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
0
123
6
123
50
123
EG005
SS2: Placebo
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
0
155
9
155
62
155
EG006
SS2: Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
0
319
8
319
121
319
EG007
SS2: Placebo/Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
0
85
2
85
36
85
EG008
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
0
59
2
59
17
59
EG009
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
0
385
32
385
216
385
EG010
SS3: Upadacitinib 7.5 mg
Participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3 for up to 52 weeks.
0
20
0
20
18
20
EG011
SS3: Upadacitinib 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 15 mg QD in Substudy 3.
0
323
24
323
181
323
EG012
SS3: Upadacitinib 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 30 mg QD in Substudy 3.
0
316
25
316
166
316
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG0030 events0 affected117 at risk
EG0040 events0 affected123 at risk
EG0050 events0 affected155 at risk
EG0060 events0 affected319 at risk
EG0072 events2 affected85 at risk
EG0080 events0 affected59 at risk
EG0090 events0 affected385 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected323 at risk
EG0121 events1 affected316 at risk
IRON DEFICIENCY ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ACUTE MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CATARACT
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ANAL FISTULA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
COLITIS ULCERATIVE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected46 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected49 at risk
EG003
COLON DYSPLASIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
DIAPHRAGMATIC HERNIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ILEUS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
DEVICE INTOLERANCE
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PYREXIA
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
HEPATITIS
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
LIVER DISORDER
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ABDOMINAL ABSCESS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ACUTE ENDOCARDITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ANAL ABSCESS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ARTHRITIS BACTERIAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
BREAST ABSCESS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
BURSITIS INFECTIVE
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
COVID-19 PNEUMONIA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CLOSTRIDIUM DIFFICILE INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
GASTROENTERITIS NOROVIRUS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
HERPES ZOSTER MENINGITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
INFECTIOUS MONONUCLEOSIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
LARGE INTESTINE INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
MASTITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
MUSCLE ABSCESS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PNEUMONIA CRYPTOCOCCAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PNEUMONIA PNEUMOCOCCAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
POST PROCEDURAL INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
RESPIRATORY SYNCYTIAL VIRUS INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
UROSEPSIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected49 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
VIRAL PHARYNGITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PULMONARY CONTUSION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
THORACIC VERTEBRAL FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CHONDROMALACIA
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ADENOCARCINOMA OF COLON
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
INVASIVE BREAST CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
SEBORRHOEIC KERATOSIS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
SMALL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CARPAL TUNNEL SYNDROME
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
SUBARACHNOID HAEMORRHAGE
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
MENTAL DISORDER
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CYSTITIS HAEMORRHAGIC
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CERVICAL DYSPLASIA
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
INTERSTITIAL LUNG DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
NONINFECTIVE BRONCHITIS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ERYTHEMA NODOSUM
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PANNICULITIS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ABORTION INDUCED
Surgical and medical procedures
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected46 at risk
EG0010 events0 affected47 at risk
EG0023 events3 affected49 at risk
EG0034 events4 affected117 at risk
EG0041 events1 affected123 at risk
EG0059 events9 affected155 at risk
EG0068 events8 affected319 at risk
EG0075 events5 affected85 at risk
EG0081 events1 affected59 at risk
EG00924 events20 affected385 at risk
EG0102 events1 affected20 at risk
EG01112 events11 affected323 at risk
EG0127 events7 affected316 at risk
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CERUMEN IMPACTION
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CATARACT
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
VISUAL IMPAIRMENT
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0013 events3 affected47 at risk
EG0021 events1 affected49 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected49 at risk
EG003
ABDOMINAL TENDERNESS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
APHTHOUS ULCER
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
COLITIS ULCERATIVE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected46 at risk
EG0011 events1 affected47 at risk
EG0022 events2 affected49 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected46 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected49 at risk
EG003
PERIANAL ERYTHEMA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected49 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PSEUDOPOLYP
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PYREXIA
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected49 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected49 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected46 at risk
EG0011 events1 affected47 at risk
EG0023 events3 affected49 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PULPITIS DENTAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
SKIN CANDIDA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected47 at risk
EG0024 events4 affected49 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected49 at risk
EG003
VAGINAL INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ACCIDENTAL OVERDOSE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected46 at risk
EG0010 events0 affected47 at risk
EG0022 events2 affected49 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0023 events3 affected49 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected49 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected49 at risk
EG003
LYMPHOCYTE COUNT INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected46 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected49 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected49 at risk
EG003
IRON DEFICIENCY
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected49 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
BURSITIS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected49 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected49 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
OSTEOPENIA
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
MALIGNANT MELANOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
MELANOCYTIC NAEVUS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected49 at risk
EG003
SKIN PAPILLOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected46 at risk
EG0014 events4 affected47 at risk
EG0024 events4 affected49 at risk
EG003
DEPRESSED MOOD
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
IRRITABILITY
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected49 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected47 at risk
EG0022 events2 affected49 at risk
EG003
PULMONARY MASS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected49 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected49 at risk
EG003
ROSACEA
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected49 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.
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.010
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
13.5
2-Sided
95
3.3
23.8
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG003
Substudy 1: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.007
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
13.8
2-Sided
95
3.8
23.9
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG000
OG004
Substudy 1: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
21.1
2-Sided
95
8.6
33.6
Difference = Upadacitinib 45 mg - Placebo
Superiority
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Units
Counts
Participants
OG000154
OG001319
Title
Denominators
Categories
Title
Measurements
OG0004.8
OG00126.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes vs. no) and Baseline Adapted Mayo score (≤ 7 vs. > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
21.6
2-Sided
95
15.8
27.4
Difference = Upadacitinib 45 mg - Placebo
Superiority
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG000149
OG001148
OG002154
Title
Denominators
Categories
Title
Measurements
OG00012.1(6.9 to 17.4)
OG00142.3(34.3 to 50.3)
OG00251.7(43.6 to 59.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
30.7
2-Sided
95
21.7
39.8
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
39.0
2-Sided
95
29.7
48.2
Difference = Upadacitinib 30 mg - Placebo
Superiority
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
OG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Units
Counts
Participants
OG00046
OG00147
OG00249
OG00352
OG00456
Title
Denominators
Categories
Title
Measurements
OG0002.2
OG00114.9
OG00230.6
OG00326.9
OG00435.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 1: Upadacitinib 7.5 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.030
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
13.1
2-Sided
95
1.2
25.0
Difference = Upadacitinib 7.5 mg - Placebo
Superiority
OG000
OG002
Substudy 1: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
27.6
2-Sided
95
13.1
42.1
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG003
Substudy 1: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
26.6
2-Sided
95
12.3
40.8
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG000
OG004
Substudy 1: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
35.4
2-Sided
95
19.2
51.7
Difference = Upadacitinib 45 mg - Placebo
Superiority
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
OG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Units
Counts
Participants
OG00046
OG00147
OG00249
OG00352
OG00456
Title
Denominators
Categories
Title
Measurements
OG0000
OG00110.6
OG00210.2
OG00311.5
OG00419.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 1: Upadacitinib 7.5 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.021
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
11.0
2-Sided
95
1.7
20.4
Difference = Upadacitinib 7.5 mg - Placebo
Superiority
OG000
OG002
Substudy 1: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.024
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
9.6
2-Sided
95
1.3
18.0
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG003
Substudy 1: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.015
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
12.2
2-Sided
95
2.3
22.0
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG000
OG004
Substudy 1: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
20.1
2-Sided
95
8.0
32.1
Difference = Upadacitinib 45 mg - Placebo
Superiority
OG002
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
OG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Units
Counts
Participants
OG00046
OG00147
OG00249
OG00352
OG00456
Title
Denominators
Categories
Title
Measurements
OG00013.0
OG00129.8
OG00249.0
OG00346.2
OG00455.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 1: Upadacitinib 7.5 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.038
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
16.7
2-Sided
95
0.9
32.5
Difference = Upadacitinib 7.5 mg - Placebo
Superiority
OG000
OG002
Substudy 1: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
35.2
2-Sided
95
17.5
52.8
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG003
Substudy 1: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
33.6
2-Sided
95
16.3
50.8
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG000
OG004
Substudy 1: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
45.1
2-Sided
95
26.2
63.9
Difference = Upadacitinib 45 mg - Placebo
Superiority
OG002
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
OG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Units
Counts
Participants
OG00046
OG00147
OG00249
OG00352
OG00456
Title
Denominators
Categories
Title
Measurements
OG00017.4
OG00123.4
OG00234.7
OG00336.5
OG00455.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 1: Upadacitinib 7.5 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.495
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
5.9
2-Sided
95
-11.1
22.9
Difference = Upadacitinib 7.5 mg - Placebo
Superiority
OG000
OG002
Substudy 1: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.074
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
15.9
2-Sided
95
-1.6
33.4
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG003
Substudy 1: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.033
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
19.2
2-Sided
95
1.6
36.9
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG000
OG004
Substudy 1: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
40.1
2-Sided
95
20.5
59.7
Difference = Upadacitinib 45 mg - Placebo
Superiority
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
OG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Units
Counts
Participants
OG00041
OG00143
OG00244
OG00344
OG00448
Title
Denominators
Categories
Title
Measurements
OG000-0.741± 2.3302
OG001-2.870± 2.9685
OG002-3.589± 2.4984
OG003-4.211± 3.0886
OG004-4.606± 2.8976
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 1: Upadacitinib 7.5 mg vs Placebo
ANCOVA
Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (<= 7 and > 7)), and Baseline value as covariate.
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
LS Mean Difference
-2.142
2-Sided
95
-3.2323
-1.0520
Difference = Upadacitinib 7.5 mg - Placebo
Superiority
OG000
OG002
Substudy 1: Upadacitinib 15 mg vs Placebo
ANCOVA
Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (<= 7 and > 7)), and Baseline value as covariate.
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
LS Mean Difference
-2.938
2-Sided
95
-4.0284
-1.8478
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG003
Substudy 1: Upadacitinib 30 mg vs Placebo
ANCOVA
Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (<= 7 and > 7)), and Baseline value as covariate.
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
LS Mean Difference
-3.736
2-Sided
95
-4.8247
-2.6470
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG000
OG004
Substudy 1: Upadacitinib 45 mg vs Placebo
ANCOVA
Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (<= 7 and > 7)), and Baseline value as covariate.
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
LS Mean Difference
-4.061
2-Sided
95
-5.1252
-2.9974
Difference = Upadacitinib 45 mg - Placebo
Superiority
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
OG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Units
Counts
Participants
OG00046
OG00147
OG00249
OG00352
OG00456
Title
Denominators
Categories
Title
Measurements
OG0000
OG0016.4
OG0024.1
OG0039.6
OG00417.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 1: Upadacitinib 7.5 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.075
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
6.6
2-Sided
95
-0.7
13.9
Difference = Upadacitinib 7.5 mg - Placebo
Superiority
OG000
OG002
Substudy 1: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.199
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
3.8
2-Sided
95
-2.0
9.6
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG003
Substudy 1: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.015
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
11.1
2-Sided
95
2.2
20.0
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG000
OG004
Substudy 1: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.004
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
17.8
2-Sided
95
5.8
29.9
Difference = Upadacitinib 45 mg - Placebo
Superiority
OG002
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
OG003
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
OG004
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Units
Counts
Participants
OG00046
OG00147
OG00249
OG00352
OG00456
Title
Denominators
Categories
Title
Measurements
OG0006.5
OG00131.9
OG00251.0
OG00344.2
OG00448.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 1: Upadacitinib 7.5 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
0.003
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
25.6
2-Sided
95
8.9
42.3
Difference = Upadacitinib 7.5 mg - Placebo
Superiority
OG000
OG002
Substudy 1: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
43.6
2-Sided
95
25.4
61.8
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG003
Substudy 1: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
39.4
2-Sided
95
21.3
57.5
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG000
OG004
Substudy 1: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
43.1
2-Sided
95
24.4
61.9
Difference = Upadacitinib 45 mg - Placebo
Superiority
Units
Counts
Participants
OG000154
OG001319
Title
Denominators
Categories
Title
Measurements
OG0007.4(3.2 to 11.5)
OG00136.3(31.0 to 41.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
29.3
2-Sided
95
22.6
35.9
Difference = Upadacitinib 45 mg - Placebo
Superiority
Units
Counts
Participants
OG000154
OG001319
Title
Denominators
Categories
Title
Measurements
OG0001.3(0.0 to 3.1)
OG00113.7(9.9 to 17.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
12.7
2-Sided
95
8.4
17.0
Difference = Upadacitinib 45 mg - Placebo
Superiority
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Units
Counts
Participants
OG000154
OG001319
Title
Denominators
Categories
Title
Measurements
OG00027.3(20.2 to 34.3)
OG00172.6(67.7 to 77.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
46.3
2-Sided
95
38.4
54.2
Difference = Upadacitinib 45 mg - Placebo
Superiority
Units
Counts
Participants
OG000154
OG001319
Title
Denominators
Categories
Title
Measurements
OG00027.3(20.2 to 34.3)
OG00160.1(54.7 to 65.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
33.3
2-Sided
95
24.8
41.8
Superiority
Difference = Upadacitinib 45 mg - Placebo
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Units
Counts
Participants
OG000154
OG001319
Title
Denominators
Categories
Title
Measurements
OG0006.6(2.6 to 10.5)
OG00130.1(25.0 to 35.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
23.7
2-Sided
95
17.5
30.0
Difference = Upadacitinib 45 mg - Placebo
Superiority
OG000154
OG001319
Title
Denominators
Categories
Title
Measurements
OG00021.4(14.9 to 27.9)
OG00148.4(42.9 to 53.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
27.4
2-Sided
95
19.2
35.6
Difference = Upadacitinib 45 mg - Placebo
Superiority
OG000154
OG001319
Title
Denominators
Categories
Title
Measurements
OG00023.4(16.7 to 30.1)
OG00146.6(41.1 to 52.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
23.6
2-Sided
95
15.1
32.1
Difference = Upadacitinib 45 mg - Placebo
Superiority
Units
Counts
Participants
OG000154
OG001319
Title
Denominators
Categories
Title
Measurements
OG00022.5(15.9 to 29.1)
OG00155.0(49.5 to 60.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. > 7)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
32.2
2-Sided
95
23.8
40.7
Difference = Upadacitinib 45 mg - Placebo
Superiority
Units
Counts
Participants
OG000125
OG001292
Title
Denominators
Categories
Title
Measurements
OG00021.7(16.03 to 27.28)
OG00155.3(51.54 to 59.15)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Mixed-effect model repeated measurement
MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Least Squares (LS) Mean Difference
33.7
Standard Error of the Mean
3.39
2-Sided
95
27.02
40.36
Difference = Upadacitinib 45 mg - Placebo
Superiority
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Units
Counts
Participants
OG000154
OG001319
Title
Denominators
Categories
Title
Measurements
OG0001.3(0.0 to 3.1)
OG00110.7(7.3 to 14.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or > 7), and bio-IR status (bio-IR or non-bio-IR)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Adjusted risk difference (%)
9.7
2-Sided
95
5.7
13.7
Difference = Upadacitinib 45 mg - Placebo
Superiority
Units
Counts
Participants
OG000125
OG001291
Title
Denominators
Categories
Title
Measurements
OG0002.8(1.23 to 4.44)
OG0019.5(8.44 to 10.61)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 2: Upadacitinib 45 mg vs Placebo
Mixed-effect model repeated measurement
MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status)
<0.001
The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).
Least Squares (LS) Mean Difference
6.7
Standard Error of the Mean
0.97
2-Sided
95
4.79
8.59
Difference = Upadacitinib 45 mg - Placebo
Superiority
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG000149
OG001148
OG002154
Title
Denominators
Categories
Title
Measurements
OG00014.5(8.7 to 20.3)
OG00148.7(40.5 to 56.8)
OG00261.6(53.6 to 69.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
34.4
2-Sided
95
25.1
43.7
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
46.3
2-Sided
95
36.7
55.8
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG00054
OG00147
OG00258
Title
Denominators
Categories
Title
Measurements
OG00022.2(11.1 to 33.3)
OG00159.2(45.1 to 73.4)
OG00269.7(57.7 to 81.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
37.4
2-Sided
95
20.3
54.6
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
47.0
2-Sided
95
30.7
63.3
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks.
Units
Counts
Participants
OG00054
OG00147
OG00258
Title
Denominators
Categories
Title
Measurements
OG00022.2(11.1 to 33.3)
OG00157.1(42.9 to 71.3)
OG00268.0(55.8 to 80.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
35.4
2-Sided
95
18.2
52.7
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
45.1
2-Sided
95
28.7
61.6
Difference = Upadacitinib 30 mg - Placebo
Superiority
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG00073
OG00163
OG00279
Title
Denominators
Categories
Title
Measurements
OG00019.2(9.9 to 28.4)
OG00161.6(49.6 to 73.7)
OG00269.5(59.1 to 80.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
42.0
2-Sided
95
27.8
56.2
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
48.6
2-Sided
95
35.5
61.7
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG000149
OG001148
OG002154
Title
Denominators
Categories
Title
Measurements
OG0005.6(1.8 to 9.3)
OG00124.2(17.3 to 31.2)
OG00225.9(18.8 to 33.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
18.7
2-Sided
95
11.0
26.4
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
19.4
2-Sided
95
11.7
27.2
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG000134
OG001135
OG002144
Title
Denominators
Categories
Title
Measurements
OG00018.8(12.1 to 25.5)
OG00163.0(54.8 to 71.1)
OG00276.6(69.6 to 83.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
44.6
2-Sided
95
34.5
54.7
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
56.6
2-Sided
95
47.2
66.0
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG000149
OG001148
OG002154
Title
Denominators
Categories
Title
Measurements
OG00011.9(6.7 to 17.2)
OG00135.0(27.1 to 42.8)
OG00249.8(41.5 to 58.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
23.8
2-Sided
95
14.8
32.8
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
37.3
2-Sided
95
27.8
46.8
Difference = Upadacitinib 30 mg - Placebo
Superiority
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG000149
OG001148
OG002154
Title
Denominators
Categories
Title
Measurements
OG00017.9(10.79 to 25.00)
OG00149.2(42.59 to 55.89)
OG00258.9(52.14 to 65.59)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
ANCOVA
Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
LS Mean Difference
31.3
Standard Error of the Mean
4.77
2-Sided
95
21.98
40.70
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
ANCOVA
Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
LS Mean Difference
41.0
Standard Error of the Mean
4.88
2-Sided
95
31.39
50.55
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG001
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG000149
OG001148
OG002154
Title
Denominators
Categories
Title
Measurements
OG0004.7(1.3 to 8.2)
OG00117.6(11.4 to 23.8)
OG00219.0(12.6 to 25.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
13.0
2-Sided
95
6.0
20.0
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
13.6
2-Sided
95
6.6
20.6
Difference = Upadacitinib 30 mg - Placebo
Superiority
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG000149
OG001148
OG002154
Title
Denominators
Categories
Title
Measurements
OG00017.4(11.4 to 23.5)
OG00156.1(48.1 to 64.1)
OG00263.6(56.0 to 71.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
38.7
2-Sided
95
28.9
48.5
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
45.1
2-Sided
95
35.5
54.8
Difference = Upadacitinib 30 mg - Placebo
Superiority
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG000149
OG001148
OG002154
Title
Denominators
Categories
Title
Measurements
OG00020.8(14.2 to 27.3)
OG00145.9(37.9 to 54.0)
OG00255.3(47.4 to 63.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
24.3
2-Sided
95
14.2
34.5
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
Cochran-Mantel-Haenszel
Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
Adjusted risk difference (%)
33.7
2-Sided
95
23.6
43.9
Difference = Upadacitinib 30 mg - Placebo
Superiority
OG002
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks
Units
Counts
Participants
OG000149
OG001148
OG002154
Title
Denominators
Categories
Title
Measurements
OG0003.7(1.88 to 5.43)
OG0018.7(7.01 to 10.49)
OG0029.5(7.80 to 11.22)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Substudy 3: Upadacitinib 15 mg vs Placebo
ANCOVA
Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).
LS Mean Difference
5.1
2-Sided
95
2.67
7.52
Difference = Upadacitinib 15 mg - Placebo
Superiority
OG000
OG002
Substudy 3: Upadacitinib 30 mg vs Placebo
ANCOVA
Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)
<0.001
The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).