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)
Rheumatoid Arthritis
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
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
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
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.