Phase 3
Completed N=648
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Source: ClinicalTrials.gov NCT02706951 ↗Enrolled (actual)
648
Serious AEs
14.6%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14 — 41.2; 67.7; 71.2 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 study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX.
The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
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 as monotherapy in patients with rheumatoid arthritis and prior inadequate response to methotrexate: results at 260 weeks from the SELECT-MONOTHERAPY randomised study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14 |
41.2; 67.7; 71.2 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14 |
19.4; 44.7; 53.0 | <0.001 sig |
| SECONDARY Change From Baseline in in Disease Activity Score 28 (CRP) at Week 14 |
-1.20; -2.29; -2.61 | <0.001 sig |
| SECONDARY Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14 |
-0.32; -0.65; -0.73 | <0.001 sig |
| SECONDARY Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14 |
4.32; 8.28; 10.19 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 14 |
8.3; 28.1; 40.5 | <0.001 sig |
| SECONDARY Change From Baseline in Duration of Morning Stiffness at Week 14 |
-53.03; -94.56; -102.34 | 0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 14 |
15.3; 41.9; 52.1 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 14 |
2.8; 22.6; 33.0 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of RA for >= 3 months.
- Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable dose for >= 4 weeks prior to first dose of study drug.
- Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.
- Meets the following minimum disease activity criteria: >= 6 swollen joints (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
Exclusion Criteria
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
- Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.
Data sourced from ClinicalTrials.gov (NCT02706951) 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.