Eligibility NCT00456092 Psoriatic Arthritis Inclusion Criteria age at least 18 Years Yes
No
diagnosis of psoriatic arthritis (Moll and Wright criteria) including symmetrical or asymmetrical peripheral joint involvement for at least 6 months Yes
No
active psoriatic arthritis defined as at least 3 tender and at least 3 swollen joints Yes
No
Rheumatoid factor negative Yes
No
if on MTX, must be on for at least 24 weeks and on stable dose at least 56 days before screening Yes
No
if on oral steroids, must be on stable dose of prednisone <=10mg/day or equivalent for 28 days Yes
No
if on NSAID, must be on a stable dose at least 14 days prior to screening Yes
No
Lab criteria: Hb >9g/dL, HCT >27%, WBC >3000/uL and <20000/uL, neut >1500/uL, platelets >100,000/uL, creatinine <1.5mg/dL, total bilirubin <2.0mg/dL, AST and ALT < 1.5 ULN Yes
No
FCBP must have negative pregnancy tests and be on two forms of contraception throughout the study Yes
No
Males must use barrier contraception with FCBP partner Yes
No
Exclusion Criteria clinically significant diseases Yes
No
any condition placing subject at risk Yes
No
pregnant or lactating females Yes
No
history of TB infection within 3 years Yes
No
history of incompletely treated latent TB Yes
No
clinically significant abnormality on CXR at screening Yes
No
current erythrodermic, guttate or pustular psoriasis Yes
No
history of infected joint prosthesis within 5 years Yes
No
systemic therapy including sulphasalazine, leflunomide, chloroquine, hydroxychloroquine, gold, parenteral steroids, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine and fumaric acid esters within 28 days of randomization Yes
No
topical therapy for treatment of psoriasis within 14 days of randomization (except mild or moderate steroids and non medicated emollients) Yes
No
phototherapy within 28 days randomization Yes
No
etanercept within 56 days randomization Yes
No
Adalimumab, efalizumab, or infliximab within 84 days randomization Yes
No
alefacept within 24 weeks randomization Yes
No
use of any intra-articular steroids within 28 days randomization Yes
No
use of any investigational medication within 28 days randomization or 5 half-lives whichever is longer Yes
No
clinically significant abnormality on ECG at screening Yes
No
high risk factors for HIV or hepatitis B or C Yes
No
history of malignancy within 5 years (except basal cell skin carcinomas and/or fewer than 3 treated squamous cell skin carcinomas Yes
No
evidence of skin conditions at screening that would interfere with evaluations of psoriasis Yes
No
