A Study to Compare Upadacitinib (ABT-494) to Placebo in A... | NCT02720523 | Trialant
NCT02720523
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jun 7, 2023Actual
Enrollment
197Actual
Phase
Phase 2Phase 3
Conditions
Rheumatoid Arthritis
Interventions
Placebo
Upadacitinib
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT02720523
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M14-663
Secondary IDs
Not provided
Brief Title
A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
Official Title
A Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Japanese Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
Acronym
SELECTSUNRISE
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jun 2023
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
Mar 22, 2016Actual
Primary Completion Date
Aug 3, 2017Actual
Completion Date
Jun 7, 2022Actual
First Submitted Date
Mar 22, 2016
First Submission Date that Met QC Criteria
Mar 22, 2016
First Posted Date
Mar 28, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 13, 2019
Results First Submitted that Met QC Criteria
Oct 17, 2019
Results First Posted Date
Oct 21, 2019Actual
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 5, 2023
Last Update Posted Date
Jun 7, 2023Actual
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
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a randomized, double-blind study comparing ABT-494 to placebo in Japanese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response.
Following marketing approval of upadacitinib for rheumatoid arthritis in Japan, this study will become a post-marketing clinical study and include a long-term extension period.
Detailed Description
This study consisted of a 35-day screening period; a 12-week randomized, double-blind, parallel-group, placebo-controlled treatment period (Period 1); a 248-week blinded long-term extension period (Period 2); and a 30-day follow-up period (call or visit).
Participants who met eligibility criteria were randomized in a 3:3:3:1:1:1 ratio to one of six treatment groups:
Period 1: Participants will receive placebo once daily for 12 weeks.
Period 2: Participants will receive Upadacitinib 7.5 mg once daily for 248 weeks.
Drug: Placebo
Drug: Upadacitinib
Placebo / Upadacitinib 15 mg
Experimental
Period 1: Participants will receive placebo once daily for 12 weeks.
Period 2: Participants will receive upadacitinib 15 mg once daily for 248 weeks.
Drug: Placebo
Drug: Upadacitinib
Placebo / Upadacitinib 30 mg
Experimental
Period 1: Participants will receive placebo once daily for 12 weeks.
Period 2: Participants will receive upadacitinib 30 mg once daily until regulatory approval of RA indication in Japan at which point they will switch to receive upadacitinib 15 mg once daily. Participants will receive upadacitinib for 248 weeks.
Drug: Placebo
Drug: Upadacitinib
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
Experimental
Period 1: Participants will receive upadacitinib 7.5 mg once daily for 12 weeks.
Period 2: Participants will receive upadacitinib 7.5 mg once daily for 248 weeks.
Drug: Upadacitinib
Upadacitinib 15 mg / Upadacitinib 15 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Tablet; Oral
Placebo / Upadacitinib 15 mg
Placebo / Upadacitinib 30 mg
Placebo / Upadacitinib 7.5 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Baseline and Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of rheumatoid arthritis (RA) for >= 3 months who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
Subjects have been receiving conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy >= 3 months and on a stable dose for >= 4 weeks prior to the first dose of study drug.
Subject has >= 6 swollen joints (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
Subjects with prior exposure to at most one biological disease-modifying anti-rheumatic drug (bDMARD) may be enrolled (up to 20% of total number of subjects) after the required washout period. Specifically, prior to enrollment:
Subjects with limited exposure to bDMARD (< 3 months) OR
Subjects who are responding to bDMARD therapy but had to discontinue due to intolerability (regardless of treatment duration).
Exclusion Criteria:
Prior exposure to any Janus kinase (JAK) inhibitor
Subjects who are considered inadequate responders (lack of efficacy) to bDMARD therapy, after minimum 3 months treatment, as determined by the Investigator.
History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis [SpA] including ankylosing spondylitis and non-radiographic axial SpA, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]). Current diagnosis of secondary Sjogren's Syndrome is permitted.
Kameda H, Takeuchi T, Yamaoka K, Oribe M, Kawano M, Zhou Y, Othman AA, Pangan AL, Kitamura S, Meerwein S, Tanaka Y. Efficacy and safety of upadacitinib in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE): a placebo-controlled phase IIb/III study. Rheumatology (Oxford). 2020 Nov 1;59(11):3303-3313. doi: 10.1093/rheumatology/keaa084.
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.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Participants were randomized to 1 of 3 doses of upadacitinib or placebo in Period 1. Participants who completed week 12 could continue in the study; participants in the upadacitinib groups continued on the same dose of upadacitinib, participants in the placebo group switched to upadacitinib 7.5, 15, or 30 mg per the pre-specified randomization.
Recruitment Details
Participants with active rheumatoid arthritis (RA) and an inadequate response to conventional synthetic disease-modifying anti-rheumatic drug (csDMARDs) were enrolled at 49 sites in Japan.
The study is currently ongoing, results are reported up to Week 60, as of the data cutoff date of 12 July 2018.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Period 1: Placebo
Participants randomized to receive placebo once daily (QD) for 12 weeks in Period 1.
FG001
Period 1: Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
Period 1: Participants will receive upadacitinib 15 mg once daily for 12 weeks.
Period 2: Participants will receive upadacitinib 15 mg once daily for 248 weeks.
Drug: Upadacitinib
Upadacitinib 30 mg / Upadacitinib 30 mg
Experimental
Period 1: Participants will receive upadacitinib 30 mg once daily for 12 weeks.
Period 2: Participants will receive upadacitinib 30 mg once daily until regulatory approval of RA indication in Japan at which point they will switch to receive upadacitinib 15 mg once daily. Participants will receive upadacitinib for 248 weeks.
Drug: Upadacitinib
Upadacitinib
Drug
Tablet; Oral
Placebo / Upadacitinib 15 mg
Placebo / Upadacitinib 30 mg
Placebo / Upadacitinib 7.5 mg
Upadacitinib 15 mg / Upadacitinib 15 mg
Upadacitinib 30 mg / Upadacitinib 30 mg
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
ABT-494
RINVOQ™
Baseline and Week 12
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Baseline and Week 12
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Baseline and Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
Low disease activity. was defined as a DAS28 score less than or equal to 3.2. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Week 12
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Week 12
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Baseline and Week 1
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) at Week 12
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
Baseline and Week 12
Change From Baseline in Rheumatoid Arthritis Work Instability Scale (RA-WIS) at Week 12
RA-WIS is a simple validated tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23.
A score < 10 means low risk and no action is needed, scores between 10 and 17 indicate medium risk and appropriate advice and information should be given. If the score is > 17, it means high risk and it could warrant referral.
A negative change from Baseline indicates improvement.
Baseline and Week 12
Change From Baseline in the Severity of Morning Stiffness at Week 12
Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness).
Baseline and Week 12
Fukuoka
Fukuoka
810-8539
Japan
Kyushu University Hospital /ID# 148008
Fukuoka
Fukuoka
812-8582
Japan
Inoue Hospital /ID# 147966
Takasaki
Gunma
3700053
Japan
National Hospital Organization Asahikawa Medical Center /ID# 147994
The Hospital of Hyogo College of Medicine /ID# 147978
Nishinomiya-shi
Hyōgo
663-8501
Japan
National Hospital Organization Sagamihara National Hospital /ID# 148221
Sagamihara-shi
Kanagawa
252-0315
Japan
NHO Osaka Minami Med Ctr /ID# 147986
Osaka
Kawachinagano-shi
586-8521
Japan
Kumamoto Orthopaedic Hospital /ID# 147972
Kumamoto
Kumamoto
862-0976
Japan
Tohoku University Hospital /ID# 148435
Sendai
Miyagi
980-8574
Japan
Medical Corporation Keiai Kai Clinic /ID# 147975
Miyazaki
Miyazaki
880-0053
Japan
Nagaoka Red Cross Hospital /ID# 147974
Nagaoka-shi
Niigata
940-2108
Japan
Niigata Rheumatic Center /ID# 148002
Shibata-shi
Niigata
957-0054
Japan
Saitama Medical Center, Saitama Medical University /ID# 147965
Kawagoe-shi
Saitama
350-8550
Japan
Jichi Medical University Hospital /ID# 148220
Shimotsuke-shi
Tochigi
329-0498
Japan
St.Luke's International Hospital /ID# 147969
Chuo-ku
Tokyo
104-8560
Japan
Ichinomiya Municipal Hospital /ID# 147992
Ichinomiya-shi
Tokyo
491-8558
Japan
Toho University Ohashi Medical Center /ID# 148003
Meguro-ku
Tokyo
1538515
Japan
Setagaya Rheumatic Clinic /ID# 148009
Setagaya-ku
Tokyo
156-0052
Japan
Keio University Hospital /ID# 147982
Shinjuku-ku
Tokyo
160-8582
Japan
Tokyo Women's Medical University Hospital /ID# 148007
Shinjuku-ku
Tokyo
162-8666
Japan
Medical Corporation Uchida Clinic /ID# 148219
Sumida-ku
Tokyo
130-0013
Japan
Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 147980
Shimonoseki-shi
Yamaguchi
752-0976
Japan
NHO Chiba-East-Hospital /ID# 147996
Chiba
260-8712
Japan
Sugimoto Rheumatology and Internal Medicine Clinic /ID# 147989
Fukui
910-0068
Japan
Hopsital of the University of Occupational and Enviromental Health /ID# 147970
Fukuoka
8078556
Japan
Shono Rheumatism Clinic /ID# 147971
Fukuoka
814-0002
Japan
Hiroshima Rheumatology Clinic /ID# 147981
Hiroshima
730-0017
Japan
Matsubara Mayflower Hospital /ID# 147967
Katō
673-1462
Japan
Kumamoto Rheumatology Clinic /ID# 147988
Kumamoto
861-5515
Japan
St. Mary's Hospital /ID# 147979
Kurume
830-8543
Japan
Kagawa University Hospital /ID# 148001
Kyoto
615-8256
Japan
Marunouchi Hospital /ID# 147973
Matsumoto
390-0841
Japan
Yu Family Clinic /ID# 147990
Miyagi
981-0112
Japan
JP Red Cross Nagoya Daiichi /ID# 147995
Nagoya
453-8511
Japan
Kondo Clinic for Ortho & Rheum /ID# 147984
Nagoya
464-0071
Japan
Okayama City Gen Med Ctr /ID# 148000
Okayama
700-8557
Japan
Oribe Clinic of Rheumatology and Internal Medicine /ID# 149308
Ōita
870-0823
Japan
Miyashita Rheumatology Clinic /ID# 147997
Ōmura
856-0836
Japan
Sagawa Akira Rheumatology Clin /ID# 147987
Sapporo
060-0001
Japan
Sapporo City General Hospital /ID# 147968
Sapporo
060-8604
Japan
Hikarigaoka Spellman Hospital /ID# 147993
Sendai
983-0833
Japan
Honjo Rheumatism Clinic /ID# 147983
Takaoka
933-0874
Japan
Takikawa Municipal Hospital /ID# 149309
Takikawa
073-0022
Japan
Juntendo University Hospital /ID# 147999
Tokyo
113-8431
Japan
National Hospital Organization Tokyo Medical Center /ID# 147998
Tokyo
152-8902
Japan
Nihon University Itabashi Hosp /ID# 147977
Tokyo
173-0032
Japan
Oki Medical Clinic /ID# 147985
Tomakomai
053-0018
Japan
Toneyama National Hospital /ID# 148006
Toyonaka
560-8552
Japan
Derived
Kameda H, Takeuchi T, Yamaoka K, Oribe M, Kawano M, Konishi Y, Chonan S, Ikeda K, Camp HS, Tanaka Y. Long-term safety and efficacy of upadacitinib in Japanese patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: 5-year results from the SELECT-SUNRISE randomised controlled trial. RMD Open. 2025 Nov 4;11(4):e006213. doi: 10.1136/rmdopen-2025-006213.
Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.
Kameda H, Takeuchi T, Yamaoka K, Oribe M, Kawano M, Yokoyama M, Pangan AL, Konishi Y, Meerwein S, Tanaka Y. Efficacy and safety of upadacitinib over 84 weeks in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE). Arthritis Res Ther. 2021 Jan 6;23(1):9. doi: 10.1186/s13075-020-02387-6.
FG002
Period 1: Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
FG003
Period 1: Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
FG004
Period 2: Upadacitinib 7.5 mg
Participants received upadacitinib 7.5 mg QD from Week 12 to Week 260 during the long-term extension period.
FG005
Period 2: Upadacitinib 15 mg
Participants received upadacitinib 15 mg QD from Week 12 to Week 260 during the long-term extension period.
FG006
Period 2: Upadacitinib 30 mg
Participants received upadacitinib 30 mg QD from Week 12 to Week 260 during the long-term extension period.
FG00049 subjects
FG00149 subjects
FG00249 subjects
FG00350 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG00047 subjects
FG00149 subjects
FG00247 subjects
FG00344 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0036 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0035 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Period 2: Long-term Extension Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00465 subjectsIncludes participants originally randomized to placebo and upadacitinib 7.5 mg
FG00562 subjectsIncludes participants originally randomized to placebo and upadacitinib 15 mg
FG00660 subjectsIncludes participants originally randomized to placebo and upadacitinib 30 mg
COMPLETED
Completed study as of the data cutoff date of 12 July 2018
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Ongoing
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
BG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
BG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
BG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00049
BG00149
BG00249
BG00350
BG004197
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
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG00249
ParticipantsBG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Japanese
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Duration of RA Diagnosis
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Prior Biological Disease-modifying Anti-rheumatic Drug (bDMARD) Use
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Tender Joint Count
A total of 68 joints were assessed for the presence or absence of tenderness.
Mean
Standard Deviation
joints
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Swollen Joint Count
A total of 66 joints were assessed for the presence or absence of swelling.
Mean
Standard Deviation
joints
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Patient's Assessment of Pain
Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale (VAS) from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain."
Mean
Standard Deviation
mm
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Patient's Global Assessment of Disease Activity
The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.
Mean
Standard Deviation
mm
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Physician's Global Assessment of Disease Activity
The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a VAS scale from 0 to 100 mm, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.
Participants with available data
Mean
Standard Deviation
mm
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG001
High-sensitivity C-reactive Protein (hsCRP)
Mean
Standard Deviation
mg/L
Title
Denominators
Categories
ParticipantsBG00049
ParticipantsBG00149
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
OG003
Upadacitinib 30 mg
Participants randomized to receive upadacitinib 30 mg once daily for 12 weeks in Period 1.
Units
Counts
Participants
OG00049
OG00149
OG00249
OG003
Title
Denominators
Categories
Title
Measurements
OG00042.9(29.0 to 56.7)
OG00175.5(63.5 to 87.6)
OG00283.7(73.3 to 94.0)
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
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.
<0.001
Response Rate Difference
32.7
2-Sided
95
14.3
51.0
Response Rate Difference = Upadacitinib - Placebo
Superiority
OG000
OG002
Secondary
Change From Baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Full analysis set; multiple imputation was used for missing data.
Posted
Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
OG003
Upadacitinib 30 mg
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Full analysis set participants with available data at baseline; multiple imputation was used for missing data.
Posted
Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Secondary
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Secondary
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Secondary
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.
Posted
Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Secondary
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
Low disease activity. was defined as a DAS28 score less than or equal to 3.2. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Secondary
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Secondary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Full analysis set; participants who prematurely discontinued from study drug prior to Week 1 or for whom ACR data were missing at Week 1 were considered non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 1
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Secondary
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) at Week 12
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.
Posted
Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Secondary
Change From Baseline in Rheumatoid Arthritis Work Instability Scale (RA-WIS) at Week 12
RA-WIS is a simple validated tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23.
A score < 10 means low risk and no action is needed, scores between 10 and 17 indicate medium risk and appropriate advice and information should be given. If the score is > 17, it means high risk and it could warrant referral.
A negative change from Baseline indicates improvement.
Full analysis set participants who were working and with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.
Posted
Geometric Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Secondary
Change From Baseline in the Severity of Morning Stiffness at Week 12
Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness).
Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.
Posted
Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo once daily for 12 weeks in Period 1.
OG001
Upadacitinib 7.5 mg
Participants randomized to receive upadacitinib 7.5 mg once daily for 12 weeks in Period 1.
OG002
Upadacitinib 15 mg
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
OG003
Upadacitinib 30 mg
Time Frame
Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Period 1: Placebo
Participants received placebo once daily for 12 weeks in Period 1.
0
49
0
49
11
49
EG001
Period 1: Upadacitinib 7.5 mg
Participants received upadacitinib 7.5 mg once daily for 12 weeks in Period 1
0
49
1
49
20
49
EG002
Period 1: Upadacitinib 15 mg
Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1
0
49
1
49
15
49
EG003
Period 1: Upadacitinib 30 mg
Participants received upadacitinib 30 mg once daily for 12 weeks in Period 1.
0
50
5
50
27
50
EG004
Period 1+2: Upadacitinib 7.5 mg
Participants originally randomized to upadacitinib 7.5 mg received upadacitinib 7.5 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 7.5 mg from Week 12 to Week 60.
0
65
9
65
55
65
EG005
Period 1+2: Upadacitinib 15 mg
Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 15 mg from Week 12 to Week 60.
0
64
14
64
55
64
EG006
Period 1+2: Upadacitinib 30 mg
Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg once daily for 12 weeks in Period 1 and up to Week 60 in Period 2. Participants originally randomized to placebo received upadacitinib 30 mg from Week 12 to Week 60.
2
66
18
66
60
66
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Sudden hearing loss
Ear and labyrinth disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG0030 events0 affected50 at risk
EG0040 events0 affected65 at risk
EG0051 events1 affected64 at risk
EG0060 events0 affected66 at risk
Colitis ischaemic
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected49 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Philadelphia chromosome positive
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Acute lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Epiglottic cyst
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG0032 events2 affected50 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected64 at risk
EG0068 events5 affected66 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected49 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0012 events2 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected49 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected49 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected49 at risk
EG0013 events3 affected49 at risk
EG0021 events1 affected49 at risk
EG003
Pyrexia
General disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected49 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected49 at risk
EG0021 events1 affected49 at risk
EG003
Cystitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected49 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0022 events1 affected49 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Influenza
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0008 events5 affected49 at risk
EG0016 events5 affected49 at risk
EG0026 events6 affected49 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected49 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected49 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected49 at risk
EG003
Liver function test increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected49 at risk
EG0023 events3 affected49 at risk
EG003
Weight increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected49 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected49 at risk
EG0020 events0 affected49 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0013 events3 affected49 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.