EUCTR2016-004130-24-EEActive, not recruitingPhase 1
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) – SELECT – PsA 1
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 1,705
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or female, at least 18 years of age
- •2. Diagnosed with psoriatic arthritis with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR)
- •3. Subject 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
- •4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
- •5. Subject is on current treatment with = 2 nonbiologic DMARDs
- •6. Subject has had an inadequate response to previous or current treatment with at least 1 non-biologic DMARD (MTX, SSZ, LEF, cyclosporine, apremilast, bucillamine, or iguratimod), or subject has an intolerance to or contraindication for DMARDs
- •7. Presence of either at Screening:
- •= 1 erosion on x-ray
- •hs-CRP > laboratory-defined upper limit of normal (ULN)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1468
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 237
Exclusion Criteria
- •1. Prior exposure to any Janus Kinase (JAK) inhibitor
- •2. Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than MTX, SSZ, LEF, apremilast, HCQ, bucillamine, or iguratimod; or use of MTX in combination with LEF.
Investigators
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