Phase 3
Completed N=661
A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone
Source: ClinicalTrials.gov NCT02675426 ↗Enrolled (actual)
661
Serious AEs
15.8%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 — 35.7; 63.8; 66.2 percentage of participants — p=<0.001
◆ Published Evidence
Established
51citations · ~17 / year
Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme.
Summary
The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.
Linked Publications (5)
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Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme.
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MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
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Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis.
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Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease.
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Upadacitinib in Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs: Efficacy and Safety Through 5 Years (SELECT-NEXT).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 |
35.7; 63.8; 66.2 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 |
17.2; 48.4; 47.9 | <0.001 sig |
| SECONDARY Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12 |
-1.02; -2.20; -2.34 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 |
-0.25; -0.59; -0.54 | <0.001 sig |
| SECONDARY Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary (PCS) Score at Week 12 |
3.03; 7.58; 8.01 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12 |
10.0; 30.8; 28.3 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12 |
19.0; 40.3; 42.0 | <0.001 sig |
| SECONDARY Change From Baseline in Duration of Morning Stiffness at Week 12 |
-34.27; -85.28; -85.13 | <0.001 sig |
| SECONDARY Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12 |
2.96; 7.91; 7.74 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 |
14.9; 38.0; 43.4 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 |
5.9; 20.8; 26.5 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1 |
8.6; 22.2; 28.3 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Adult male or female, at least 18 years old.
- Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months.
- Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
- Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
- Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods.
Exclusion Criteria
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
- Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
Data sourced from ClinicalTrials.gov (NCT02675426) 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.