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 (bDMARD)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Rheumatic Diseases
Intervention: Upadacitinib; Placebo
Intervention description: Oral tablet; Oral tablet
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 642.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arthritis; Psoriasis; Anti-Rheumatic; Anti-inflammatory; Joint disease; Musculoskeletal disease

Summary:

      The study objectives of Period 1 are to compare the efficacy, safety, and tolerability of
      upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo for the treatment of signs and
      symptoms in adults with moderately to severely active psoriatic arthritis (PsA) who have had
      an inadequate response or intolerance to biologic disease-modifying anti-rheumatic drug
      (bDMARD).

      The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of
      upadacitinib 15 mg QD and 30 mg QD in participants who have 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.