Phase 3
Completed N=499
A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
Source: ClinicalTrials.gov NCT02706847 ↗Enrolled (actual)
499
Serious AEs
18.0%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 — 28.4; 64.6; 56.4 percentage of participants — p=<0.001
◆ Published Evidence
Established
52citations · ~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 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.
The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who 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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Long-term sustainability of response to upadacitinib among patients with active rheumatoid arthritis refractory to biological treatments: results up to 5 years from SELECT-BEYOND.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 |
28.4; 64.6; 56.4 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 |
14.2; 43.3; 42.4 | <0.001 sig |
| SECONDARY Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12 |
-1.02; -2.31; -2.29 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 |
-0.17; -0.39; -0.42 | <0.001 sig |
| SECONDARY Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 |
2.39; 5.83; 7.02 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 |
11.8; 34.1; 35.8 | <0.001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 |
6.5; 11.6; 23.0 | 0.110 |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1 |
10.7; 27.4; 24.8 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of rheumatoid arthritis (RA) for≥ 3 months.
- Treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug.
- Participant has been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
- Meets both of the following criteria:
- ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
- hsCRP ≥ 3mg/L at Screening Visit.
Exclusion Criteria
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- 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 including ankylosing spondylitis and non-radiographic axial spondyloarthritis, 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 (NCT02706847) 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.