Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Abatacept; Placebo
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 489.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of
      psoriatic arthritis
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects at least 18 years of age who have a diagnosis of PsA by Classification
             Criteria for Psoriatic Arthritis (CASPAR)

          -  Subjects have active PsA as shown by a minimum of ≥3 swollen joints and ≥3 tender
             joints (66/68 joint counts) at screening and randomization/Day 1 (prior to study drug
             administration). At least one of the swollen joints must be in the digit of the hand
             or foot

          -  Subjects with at least one confirmed ≥2 cm target lesion of plaque psoriasis in a
             region of the body that can be evaluated excluding the axilla, genitals, groin, palms,
             and soles

          -  Subjects must have had an inadequate response or intolerance to at least one
             non-biologic disease-modifying anti-rheumatic drug (DMARD)

          -  Subjects may have been exposed to TNFi therapy. Subjects may have discontinued for any
             reason (inadequate response, intolerance or other)

          -  Subjects may enroll on certain concomitant non-biologic DMARDs (Methotrexate,
             Leflunomide, Sulfasalazine, or Hydroxychloroquine) provided the medication has been
             used for at least 3 months with a stable dose for at least 28 days prior to
             randomization (Day 1)

          -  If using oral corticosteroids (≤10 mg mg/day Prednisone equivalent), dose must be
             stable ≥14 days prior to randomization (Day 1)

          -  Subjects may enroll on systemic retinoids (eg: Acitretin) provided the medication has
             been used for at least 3 months with a stable dose for at least 28 days prior to
             randomization (Day 1)

        Exclusion Criteria:

          -  Subjects with guttate, pustular, or erythrodermic psoriasis

          -  Subjects who have had prior exposure to Abatacept (CTLA 4Ig) or other CTLA4 therapies

          -  Subjects who have been exposed to any investigational drug within 4 weeks or 5 half
             lives, whichever is longer

          -  Female subjects who had a breast cancer screening study that is suspicious for
             malignancy, and in whom the possibility of malignancy cannot be reasonably excluded
             following additional clinical, laboratory or other diagnostic evaluations

          -  Subjects with a history of cancer within the last 5 years (other than non-melanoma
             skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers
             must be removed prior to dosing. Subjects with carcinoma in situ, treated with
             definitive surgical intervention prior to study enrollment are allowed

          -  Subjects with any bacterial infection within the last 60 days prior to screening
             (enrollment), unless treated and resolved with antibiotics, or any chronic bacterial
             infection (such as chronic pyelonephritis, osteomyelitis and bronchiectasis)

          -  Subjects at risk for tuberculosis (TB). Specifically, subjects with:

               -  Current clinical, radiographic or laboratory evidence of active TB

               -  A history of active TB within the last 3 years even if it was treated

               -  A history of active TB greater than 3 years ago unless there is documentation
                  that the prior anti-TB treatment was appropriate in duration and type

               -  Latent TB which was not successfully treated

               -  Subjects with a positive TB screening test indicative of latent TB will not be
                  eligible for the study unless they have no evidence of current TB on chest x-ray
                  at screening and they are actively being treated for TB with isoniazid (INH) or
                  other therapy for latent TB given according to local health authority guidelines
                  (eg: Center for Disease Control). Treatment must have been given for at least 4
                  weeks prior to randomization (Day 1). These subjects should complete treatment
                  according to local health authority guidelines

          -  Subjects with herpes zoster that resolved less than 2 months prior to enrollment

          -  Subjects with evidence (as measured by the investigator) of active or latent
             bacterial, active viral, or serious latent viral infections at the time of enrollment,
             including subjects with evidence of Immunodeficiency Virus (HIV) infection

          -  Subjects who are not currently treated with a non-biologic DMARD and have clinical or
             radiographic evidence of arthritis mutilans (eg: digital telescoping or
             "pencil-in-cup" radiographic changes)

          -  Subjects who have failed more than 2 TNFi due to inefficacy defined as inadequate
             response after 3 months treatment at a therapeutic dose

          -  Subjects who have received TNFi therapy within 4 weeks for etanercept or within 8
             weeks for adalimumab, certolizumab, infliximab, or golimumab

          -  Subjects who have received prior use of apremilast within 4 weeks, ustekinumab within
             20 weeks or briakinumab within 8 weeks

          -  Subjects who have discontinued a non-biologic DMARD or systemic retinoid within four
             weeks or five half-lives, whichever is longer, prior to randomization (Day 1)

          -  Use of any of the following within 28 days or five half lives whichever is longer
             prior to randomization (Day 1): Cyclosporine A, oral Tacrolimus, Mycophenolate Mofetil
             (MMF), Hydroxyurea, Fumaric Acid Esters, Paclitaxel, 6-Thioguanine, 6-Mercatopurine,
             or Tofacitinib