Back to resultsA 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 (SELECTSUNRISE)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Upadacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, ABT-494, Japanese, Antirheumatic agents
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.
Sites / Locations
- Nagoya University Hospital /ID# 148005
- Hamanomachi Hospital /ID# 147991
- Kyushu University Hospital /ID# 148008
- Inoue Hospital /ID# 147966
- National Hospital Organization Asahikawa Medical Center /ID# 147994
- Katayama Orthopedic Rheumatology Clinic /ID# 147976
- The Hospital of Hyogo College of Medicine /ID# 147978
- National Hospital Organization Sagamihara National Hospital /ID# 148221
- NHO Osaka Minami Med Ctr /ID# 147986
- Kumamoto Orthopaedic Hospital /ID# 147972
- Tohoku University Hospital /ID# 148435
- Medical Corporation Keiai Kai Clinic /ID# 147975
- Nagaoka Red Cross Hospital /ID# 147974
- Niigata Rheumatic Center /ID# 148002
- Saitama Medical Center, Saitama Medical University /ID# 147965
- Jichi Medical University Hospital /ID# 148220
- St.Luke's International Hospital /ID# 147969
- Ichinomiya Municipal Hospital /ID# 147992
- Toho University Ohashi Medical Center /ID# 148003
- Setagaya Rheumatic Clinic /ID# 148009
- Keio University Hospital /ID# 147982
- Tokyo Women's Medical University Hospital /ID# 148007
- Medical Corporation Uchida Clinic /ID# 148219
- Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 147980
- NHO Chiba-East-Hospital /ID# 147996
- Sugimoto Rheumatology and Internal Medicine Clinic /ID# 147989
- Hopsital of the University of Occupational and Enviromental Health /ID# 147970
- Shono Rheumatism Clinic /ID# 147971
- Hiroshima Rheumatology Clinic /ID# 147981
- Matsubara Mayflower Hospital /ID# 147967
- Kumamoto Rheumatology Clinic /ID# 147988
- St. Mary's Hospital /ID# 147979
- Kagawa University Hospital /ID# 148001
- Marunouchi Hospital /ID# 147973
- Yu Family Clinic /ID# 147990
- JP Red Cross Nagoya Daiichi /ID# 147995
- Kondo Clinic for Ortho & Rheum /ID# 147984
- Oribe Clinic of Rheumatology and Internal Medicine /ID# 149308
- Okayama City Gen Med Ctr /ID# 148000
- Miyashita Rheumatology Clinic /ID# 147997
- Sagawa Akira Rheumatology Clin /ID# 147987
- Sapporo City General Hospital /ID# 147968
- Hikarigaoka Spellman Hospital /ID# 147993
- Honjo Rheumatism Clinic /ID# 147983
- Takikawa Municipal Hospital /ID# 149309
- Juntendo University Hospital /ID# 147999
- National Hospital Organization Tokyo Medical Center /ID# 147998
- Nihon University Itabashi Hosp /ID# 147977
- Oki Medical Clinic /ID# 147985
- Toneyama National Hospital /ID# 148006
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo / Upadacitinib 7.5 mg
Placebo / Upadacitinib 15 mg
Placebo / Upadacitinib 30 mg
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
Upadacitinib 15 mg / Upadacitinib 15 mg
Upadacitinib 30 mg / Upadacitinib 30 mg
Arm Description
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.
Period 1: Participants will receive placebo once daily for 12 weeks. Period 2: Participants will receive upadacitinib 15 mg once daily for 248 weeks.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Percentage of Participants 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.
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.
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).
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.
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.
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 Information
1. Study Identification
Unique Protocol Identification Number
NCT02720523
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
Acronym
SELECTSUNRISE
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2016 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
June 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Group 1: Upadacitinib 7.5 mg QD (Period 1) → upadacitinib 7.5 mg QD (Period 2)
Group 2: Upadacitinib 15 mg QD (Period 1) → upadacitinib 15 mg QD (Period 2)
Group 3: Upadacitinib 30 mg QD (Period 1) → upadacitinib 30 mg QD (Period 2)
Group 4: Placebo (Period 1) → upadacitinib 7.5 mg QD (Period 2)
Group 5: Placebo (Period 1) → upadacitinib 15 mg QD (Period 2)
Group 6: Placebo (Period 1) → upadacitinib 30 mg QD (Period 2)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, ABT-494, Japanese, Antirheumatic agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo / Upadacitinib 7.5 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo / Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
Period 1: Participants will receive placebo once daily for 12 weeks.
Period 2: Participants will receive upadacitinib 15 mg once daily for 248 weeks.
Arm Title
Placebo / Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Upadacitinib 15 mg / Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Upadacitinib 30 mg / Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ™
Intervention Description
Tablet; Oral
Primary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12
Description
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12
Description
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
≥ 70% improvement in 68-tender joint count;
≥ 70% improvement in 66-swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 12
Title
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Description
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Time Frame
Baseline and Week 1
Title
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Rheumatoid Arthritis Work Instability Scale (RA-WIS) at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in the Severity of Morning Stiffness at Week 12
Description
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).
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya University Hospital /ID# 148005
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Hamanomachi Hospital /ID# 147991
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-8539
Country
Japan
Facility Name
Kyushu University Hospital /ID# 148008
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Inoue Hospital /ID# 147966
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
3700053
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center /ID# 147994
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Katayama Orthopedic Rheumatology Clinic /ID# 147976
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8243
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine /ID# 147978
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
National Hospital Organization Sagamihara National Hospital /ID# 148221
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-0315
Country
Japan
Facility Name
NHO Osaka Minami Med Ctr /ID# 147986
City
Osaka
State/Province
Kawachinagano-shi
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Kumamoto Orthopaedic Hospital /ID# 147972
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Tohoku University Hospital /ID# 148435
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Medical Corporation Keiai Kai Clinic /ID# 147975
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
880-0053
Country
Japan
Facility Name
Nagaoka Red Cross Hospital /ID# 147974
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-2108
Country
Japan
Facility Name
Niigata Rheumatic Center /ID# 148002
City
Shibata-shi
State/Province
Niigata
ZIP/Postal Code
957-0054
Country
Japan
Facility Name
Saitama Medical Center, Saitama Medical University /ID# 147965
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Jichi Medical University Hospital /ID# 148220
City
Shimotsuke-shi
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
St.Luke's International Hospital /ID# 147969
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Ichinomiya Municipal Hospital /ID# 147992
City
Ichinomiya-shi
State/Province
Tokyo
ZIP/Postal Code
491-8558
Country
Japan
Facility Name
Toho University Ohashi Medical Center /ID# 148003
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
1538515
Country
Japan
Facility Name
Setagaya Rheumatic Clinic /ID# 148009
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
156-0052
Country
Japan
Facility Name
Keio University Hospital /ID# 147982
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital /ID# 148007
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Medical Corporation Uchida Clinic /ID# 148219
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
130-0013
Country
Japan
Facility Name
Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 147980
City
Shimonoseki-shi
State/Province
Yamaguchi
ZIP/Postal Code
752-0976
Country
Japan
Facility Name
NHO Chiba-East-Hospital /ID# 147996
City
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Sugimoto Rheumatology and Internal Medicine Clinic /ID# 147989
City
Fukui
ZIP/Postal Code
910-0068
Country
Japan
Facility Name
Hopsital of the University of Occupational and Enviromental Health /ID# 147970
City
Fukuoka
ZIP/Postal Code
8078556
Country
Japan
Facility Name
Shono Rheumatism Clinic /ID# 147971
City
Fukuoka
ZIP/Postal Code
814-0002
Country
Japan
Facility Name
Hiroshima Rheumatology Clinic /ID# 147981
City
Hiroshima-Shi
ZIP/Postal Code
730-0017
Country
Japan
Facility Name
Matsubara Mayflower Hospital /ID# 147967
City
Kato
ZIP/Postal Code
673-1462
Country
Japan
Facility Name
Kumamoto Rheumatology Clinic /ID# 147988
City
Kumamoto
ZIP/Postal Code
861-5515
Country
Japan
Facility Name
St. Mary's Hospital /ID# 147979
City
Kurume
ZIP/Postal Code
830-8543
Country
Japan
Facility Name
Kagawa University Hospital /ID# 148001
City
Kyoto
ZIP/Postal Code
615-8256
Country
Japan
Facility Name
Marunouchi Hospital /ID# 147973
City
Matsumoto
ZIP/Postal Code
390-0841
Country
Japan
Facility Name
Yu Family Clinic /ID# 147990
City
Miyagi
ZIP/Postal Code
981-0112
Country
Japan
Facility Name
JP Red Cross Nagoya Daiichi /ID# 147995
City
Nagoya
ZIP/Postal Code
453-8511
Country
Japan
Facility Name
Kondo Clinic for Ortho & Rheum /ID# 147984
City
Nagoya
ZIP/Postal Code
464-0071
Country
Japan
Facility Name
Oribe Clinic of Rheumatology and Internal Medicine /ID# 149308
City
Oita
ZIP/Postal Code
870-0823
Country
Japan
Facility Name
Okayama City Gen Med Ctr /ID# 148000
City
Okayama
ZIP/Postal Code
700-8557
Country
Japan
Facility Name
Miyashita Rheumatology Clinic /ID# 147997
City
Omura
ZIP/Postal Code
856-0836
Country
Japan
Facility Name
Sagawa Akira Rheumatology Clin /ID# 147987
City
Sapporo
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Sapporo City General Hospital /ID# 147968
City
Sapporo
ZIP/Postal Code
060-8604
Country
Japan
Facility Name
Hikarigaoka Spellman Hospital /ID# 147993
City
Sendai
ZIP/Postal Code
983-0833
Country
Japan
Facility Name
Honjo Rheumatism Clinic /ID# 147983
City
Takaoka
ZIP/Postal Code
933-0874
Country
Japan
Facility Name
Takikawa Municipal Hospital /ID# 149309
City
Takikawa
ZIP/Postal Code
073-0022
Country
Japan
Facility Name
Juntendo University Hospital /ID# 147999
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center /ID# 147998
City
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Nihon University Itabashi Hosp /ID# 147977
City
Tokyo
ZIP/Postal Code
173-0032
Country
Japan
Facility Name
Oki Medical Clinic /ID# 147985
City
Tomakomai
ZIP/Postal Code
053-0018
Country
Japan
Facility Name
Toneyama National Hospital /ID# 148006
City
Toyonaka
ZIP/Postal Code
560-8552
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
32277824
Citation
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.
Results Reference
background
PubMed Identifier
34041702
Citation
Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.
Results Reference
derived
PubMed Identifier
33407801
Citation
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.
Results Reference
derived
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M14-663#additional-resources-section
Description
clinical study report synopsis
Learn more about this trial
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
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