Phase 3
N=642
A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03104374 ↗Enrolled (actual)
642
Serious AEs
9.3%
Results posted
Jan 2022
Primary outcome: Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 — 24.1; 56.9; 63.8 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Upadacitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 |
24.1; 56.9; 63.8 | <0.0001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 |
-0.10; -0.30; -0.41 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16 |
9.2; 36.8; 40.2 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16 |
16.0; 52.3; 56.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 |
1.62; 5.15; 7.06 | <0.0001 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12 |
1.3; 5.0; 6.1 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 |
2.8; 25.1; 28.9 | <0.0001 sig |
| SECONDARY Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16 |
-1.5; -24.4; -29.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 |
4.7; 31.8; 37.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 |
0.5; 8.5; 16.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2 |
10.8; 32.7; 33.5 | <0.0001 sig |
Summary
This is a Phase 3 multicenter study that included two periods. Period 1 was designed to compare the safety, tolerability, and efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who had an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluated the safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who completed Period 1.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
- Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
- Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
- Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD.
Exclusion Criteria
- Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
- Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than Methotrexate (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast, Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
- History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.
Data sourced from ClinicalTrials.gov (NCT03104374). 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.