Phase 3
Completed N=197
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
Source: ClinicalTrials.gov NCT02720523 ↗Enrolled (actual)
197
Serious AEs
12.2%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 — 42.9; 75.5; 83.7; 80.0 percentage of participants — p=<0.001
◆ Published Evidence
Established
65citations · ~11 / year
Efficacy and safety of upadacitinib in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE): a placebo-controlled phase IIb/III study.
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.
Linked Publications (4)
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Efficacy and safety of upadacitinib in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE): a placebo-controlled phase IIb/III study.
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Efficacy and safety of upadacitinib over 84 weeks in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE).
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The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 |
42.9; 75.5; 83.7; 80.0 | <0.001 sig |
| SECONDARY Change From Baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12 |
-0.79; -2.08; -2.39; -2.41 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12 |
-0.10; -0.41; -0.45; -0.49 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 |
16.3; 40.8; 65.3; 58.0 | 0.007 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 |
2.0; 20.4; 34.7; 28.0 | 0.004 sig |
| SECONDARY Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 |
2.88; 7.21; 6.38; 8.81 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 |
18.4; 53.1; 69.4; 72.0 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12 |
6.1; 36.7; 57.1; 50.0 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1 |
8.2; 30.6; 24.5; 34.0 | 0.006 sig |
| SECONDARY Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) at Week 12 |
1.81; 4.47; 3.60; 2.66 | 0.040 sig |
| SECONDARY Change From Baseline in Rheumatoid Arthritis Work Instability Scale (RA-WIS) at Week 12 |
-0.69; -3.22; -2.74; -2.24 | 0.021 sig |
| SECONDARY Change From Baseline in the Severity of Morning Stiffness at Week 12 |
-1.02; -2.83; -2.84; -2.98 | <0.001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02720523) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.