Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis

For more information regarding BMS clinical trial participation, please visitwww.BMSStudyConnect.com Inclusion Criteria:

• Subjects at least 18 years of age who have a diagnosis of PsA by ClassificationCriteria for Psoriatic Arthritis (CASPAR)
• Subjects have active PsA as shown by a minimum of ≥3 swollen joints and ≥3 tenderjoints (66/68 joint counts) at screening and randomization/Day 1 (prior to study drugadministration). At least one of the swollen joints must be in the digit of the handor foot
• Subjects with at least one confirmed ≥2 cm target lesion of plaque psoriasis in aregion 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 onenon-biologic disease-modifying anti-rheumatic drug (DMARD)
• Subjects may have been exposed to TNFi therapy. Subjects may have discontinued for anyreason (inadequate response, intolerance or other)
• Subjects may enroll on certain concomitant non-biologic DMARDs (Methotrexate,Leflunomide, Sulfasalazine, or Hydroxychloroquine) provided the medication has beenused for at least 3 months with a stable dose for at least 28 days prior torandomization (Day 1)
• If using oral corticosteroids (≤10 mg mg/day Prednisone equivalent), dose must bestable ≥14 days prior to randomization (Day 1)
• Subjects may enroll on systemic retinoids (eg: Acitretin) provided the medication hasbeen used for at least 3 months with a stable dose for at least 28 days prior torandomization (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 halflives, whichever is longer
• Female subjects who had a breast cancer screening study that is suspicious formalignancy, and in whom the possibility of malignancy cannot be reasonably excludedfollowing additional clinical, laboratory or other diagnostic evaluations
• Subjects with a history of cancer within the last 5 years (other than non-melanomaskin cell cancers cured by local resection). Existing non-melanoma skin cell cancersmust be removed prior to dosing. Subjects with carcinoma in situ, treated withdefinitive 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 bacterialinfection (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 documentationthat 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 beeligible for the study unless they have no evidence of current TB on chest x-rayat screening and they are actively being treated for TB with isoniazid (INH) orother therapy for latent TB given according to local health authority guidelines (eg: Center for Disease Control). Treatment must have been given for at least 4weeks prior to randomization (Day 1). These subjects should complete treatmentaccording 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 latentbacterial, 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 orradiographic 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 inadequateresponse after 3 months treatment at a therapeutic dose
• Subjects who have received TNFi therapy within 4 weeks for etanercept or within 8weeks 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 fourweeks 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 longerprior to randomization (Day 1): Cyclosporine A, oral Tacrolimus, Mycophenolate Mofetil (MMF), Hydroxyurea, Fumaric Acid Esters, Paclitaxel, 6-Thioguanine, 6-Mercatopurine,or Tofacitinib