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
SELECTSUNRISE
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
1 other identifier
interventional
197
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Mar 2016
Longer than P75 for phase_2 rheumatoid-arthritis
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2016
CompletedStudy Start
First participant enrolled
March 22, 2016
CompletedFirst Posted
Study publicly available on registry
March 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2017
CompletedResults Posted
Study results publicly available
October 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2022
CompletedJune 7, 2023
June 1, 2023
1.4 years
March 22, 2016
September 13, 2019
June 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 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 (11)
Change From Baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12
Baseline and Week 12
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Baseline and Week 12
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Baseline and Week 12
- +6 more secondary outcomes
Study Arms (6)
Placebo / Upadacitinib 7.5 mg
EXPERIMENTALPeriod 1: Participants will receive placebo once daily for 12 weeks. Period 2: Participants will receive Upadacitinib 7.5 mg once daily for 248 weeks.
Placebo / Upadacitinib 15 mg
EXPERIMENTALPeriod 1: Participants will receive placebo once daily for 12 weeks. Period 2: Participants will receive upadacitinib 15 mg once daily for 248 weeks.
Placebo / Upadacitinib 30 mg
EXPERIMENTALPeriod 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.
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
EXPERIMENTALPeriod 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.
Upadacitinib 15 mg / Upadacitinib 15 mg
EXPERIMENTALPeriod 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.
Upadacitinib 30 mg / Upadacitinib 30 mg
EXPERIMENTALPeriod 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.
Interventions
Tablet; Oral
Tablet; Oral
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (50)
Nagoya University Hospital /ID# 148005
Nagoya, Aichi-ken, 466-8560, Japan
Hamanomachi Hospital /ID# 147991
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
Asahikawa, Hokkaido, 070-8644, Japan
Katayama Orthopedic Rheumatology Clinic /ID# 147976
Asahikawa, Hokkaido, 078-8243, Japan
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
Related Publications (3)
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.
PMID: 32277824BACKGROUNDYamaoka 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.
PMID: 34041702DERIVEDKameda 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.
PMID: 33407801DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2016
First Posted
March 28, 2016
Study Start
March 22, 2016
Primary Completion
August 3, 2017
Study Completion
June 7, 2022
Last Updated
June 7, 2023
Results First Posted
October 21, 2019
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.