Trial Search Results

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

This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in subjects with PsA who have completed Period 1.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AbbVie

Stanford Investigator(s):

Intervention(s):

  • Drug: Placebo
  • Drug: ABT-494

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting