None listed
Conditions
Interventions
This is a 24 week (168 days) study, followed by a 28 week (196 days) open-label period in subjects with active PsA based on the Classification. Criteria for Psoriatic Arthritis (CASPAR), who have had
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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. -Subjects must have had an inadequate response or intolerance to at least one non-biologic disease-modifying anti-rheumatic drug (DMARD). -If currently on a non-biologic DMARD (methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) the medication must have been used for at least 3 months with a stable dose for at least 28 days prior to randomization(Day 1). -Subjects may have been exposed to TNFi therapy. -Subjects may have discontinued for any reason (inadequate response, intolerance or other). If using oral corticosteroids ( 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
Exclusion criteria: -Subjects with guttate, pustular, or erythrodermic psoriasis/Subjects who have had prior exposure to abatacept (CTLA 4Ig)/Subjects who have been exposed to anyinvestigational drug within 4 weeks or 5 half lives,/Prior use of apremilast or ustekinumab/Female subjects who had a breast cancer screening study that is suspicious for malignancy/Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)./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./Subjects at risk for tuberculosis (TB)./ Subjects with herpes zoster that resolved less than 2 months prior to enrollment./Subjects with evidence of active or latent bacterial, active viral, or serious latent viral infections at the time of enrollment, including subjects with evidence of (HIV) infection/Subjects who are not currently treated with a non-biologic DMARD and have clinical or radiographic evidence of arthritis mutilans/ subjects who have taken > 2 TNFis/Subjects who have received TNFi therapy within 8 weeks for adalimumab, etanercept, or certolizumab or within 12 weeks for infliximab or golimumab/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
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, France, Germany, Israel, Italy, Mexico, New Zealand, Poland, South Africa, Spain, Switzerland, United States
Contacts
Public ContactMarina Ordonez
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed