Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Abatacept; Placebo
Intervention description: Solution, intravenous, monthly, short-term = 24 weeks (6 months); Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine an optimal abatacept dosing regimen for the
      treatment of active arthritis due to psoriatic arthritis in patients who have had a prior
      inadequate response to disease-modifying antirheumatic drugs, including methotrexate and
      tumor necrosis factor alpha-blockade compounds.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Meeting classification criteria for psoriatic arthritis for a duration of disease of
             at least 3 months

          -  Prior failure (inefficacy or intolerance) of therapy with disease-modifying
             antirheumatic drugs; if patient had prior failure of methotrexate, he or she must have
             been taking at least 15 mg per week for at least 2 months

          -  If recent failure(inefficacy or intolerance) of a tumor necrosis factor α-blockade
             compound, participant must be washed out prior to first dose: 56 days for infliximab
             and 28 days for etanercept and adalimumab

          -  Disease activity as defined by a tender joint count of ≥3, swollen joint count of ≥3,
             and clinically detectable synovitis at screening and Day 01 (prior to infusion)

          -  Active psoriasis with a qualifying target lesion ≥2 cm in diameter

          -  Able to undergo magnetic resonance imaging

          -  Use of appropriate birth control by women of child bearing potential (WOCBP)

        Key Exclusion Criteria:

          -  WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
             the entire study period and for up to 10 weeks after the last dose of investigational
             product

          -  Women who are pregnant or breastfeeding or who plan to become pregnant or to start
             breastfeeding during the duration of the study

          -  Women with a positive pregnancy test on enrollment or prior to investigational product
             administration.

          -  Participants scheduled for or anticipating joint replacement surgery.

          -  Those with a recent history of clinically significant drug or alcohol abuse

          -  Concomitant illness that in the investigator's opinion is likely to require systemic
             glucocorticosteroid therapy during the study (for example: moderate to severe asthma)

          -  Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic,
             pulmonary, cardiac, neurologic, ophthalmologic, or cerebral disease.

          -  Unwillingness or inability to undergo screening based on current local or country
             guidelines/standards to evaluate the presence of cancer

          -  Cancer within the last 5 years

          -  Current malignancy or signs of possible malignancy detected by screening procedures
             for which the workup to exclude malignancy has not been completed or malignancy cannot
             be excluded

          -  At risk for or history (within 3 years) of tuberculosis

          -  Any serious bacterial infection within the last 3 months, not treated and resolved
             with antibiotics, or any chronic bacterial infection (such as, but not limited to,
             chronic pyelonephritis, osteomyelitis, and bronchiectasis)

          -  Evidence of active or latent bacterial or viral infection infections at the time of
             potential enrollment

          -  Herpes zoster or cytomegalovirus resolving less than 2 months prior to signing
             informed consent

          -  Receipt of any live vaccines within 3 months of the anticipated first dose of study
             medication or anticipation of the need for a live vaccine at any time during and for 3
             months after the duration of the study

        Long-term period participants: Must have met eligibility criteria for short-term period and
        completed short-term (24-week) period of the study