A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: adalimumab; ABT-122
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Safety; Efficacy; Methotrexate

Summary:

      This study is a Phase 2 randomized, double-blind, double-dummy, active- and
      placebo-controlled, parallel-group study designed to assess the safety, tolerability,
      efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants
      with active PsA who are inadequately responding to MTX treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PsA diagnosis of at least 3 months duration prior to the date of first screening with
             ClASsification of Psoriatic ARthritis (CASPAR) confirmed diagnosis at Screening.

          -  Have active psoriasis defined by at least 1 psoriasis lesion >= 2 cm diameter in areas
             other than the axilla or groin.

          -  Have active arthritis defined by minimum disease activity criteria:

               1. >= 3 swollen joints (based on 66 joint counts) at Screening

               2. >= 3 tender joints (based on 68 joint counts) at Screening

          -  On a stable dose of methotrexate (MTX) defined as:

               1. Oral or parenteral treatment >= 3 months

               2. On a stable dose with an unchanged mode of application for at least 4 weeks prior
                  to baseline

               3. Stable MTX dose of >= 10 mg/week and <= the upper limit of the applicable
                  approved local label

               4. Can also be on stable doses of nonsteroidal anti-inflammatory drugs,
                  sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate

        Exclusion Criteria:

          -  Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be
             enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or safety
             concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior
             to the Baseline visit.

          -  Subjects on prior adalimumab may not be enrolled in the study

          -  Prior exposure to other non-TNF inhibitor biological disease-modifying antirheumatic
             drugs (DMARDs) will be permitted if the subject is washed out at least 5 half-lives of
             these drugs prior to the baseline visit.

          -  Current treatment with traditional oral/intramuscular DMARDs, including conventional
             synthetic DMARDs (csDMARDs; except for concomitant treatment with sulfasalazine and/or
             hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5
             half-lives of a drug apart from MTX prior to the Baseline visit.

             a. Subject could have been exposed to prior Janus kinase (JAK) or phosphodiesterase
             type 4 (PDE4) inhibitors so long as they have been off therapy for at least 5
             half-lives.

          -  Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within
             the 30 days of the Baseline visit.

          -  Intra-articular or parenteral administration of corticosteroids in the preceding 4
             weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are
             allowed.

          -  Laboratory values of the following at the Screening Visit:

               1. Confirmed hemoglobin < 9 g/dL for males and < 8.5 g/dL for females

               2. Absolute neutrophil count (ANC) < 1500 mm^3, (or < 1200 cells/µL for subjects of
                  African descent who are black)

               3. Aspartate aminotransferase or alanine aminotransferase > 1.5 x the upper limit of
                  normal (ULN) or bilirubin >= 3 mg/dL

               4. Serum creatinine > 1.5 x the ULN

               5. Platelets < 100,000 cells/[mm^3] (10^9/L),

               6. Clinically significant abnormal screening laboratory results as evaluated by the
                  Investigator