Description:

ODM derived from http://clinicaltrials.gov/show/NCT00456092

Link:

http://clinicaltrials.gov/show/NCT00456092

Keywords:
Versions (2) ▾
  1. 12/9/13
  2. 4/15/14
Uploaded on:

April 15, 2014

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00456092 Psoriatic Arthritis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 18 Years
diagnosis of psoriatic arthritis (Moll and Wright criteria) including symmetrical or asymmetrical peripheral joint involvement for at least 6 months
active psoriatic arthritis defined as at least 3 tender and at least 3 swollen joints
Rheumatoid factor negative
if on MTX, must be on for at least 24 weeks and on stable dose at least 56 days before screening
if on oral steroids, must be on stable dose of prednisone <=10mg/day or equivalent for 28 days
if on NSAID, must be on a stable dose at least 14 days prior to screening
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
FCBP must have negative pregnancy tests and be on two forms of contraception throughout the study
Males must use barrier contraception with FCBP partner
Exclusion Criteria
clinically significant diseases
any condition placing subject at risk
pregnant or lactating females
history of TB infection within 3 years
history of incompletely treated latent TB
clinically significant abnormality on CXR at screening
current erythrodermic, guttate or pustular psoriasis
history of infected joint prosthesis within 5 years
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
topical therapy for treatment of psoriasis within 14 days of randomization (except mild or moderate steroids and non medicated emollients)
phototherapy within 28 days randomization
etanercept within 56 days randomization
Adalimumab, efalizumab, or infliximab within 84 days randomization
alefacept within 24 weeks randomization
use of any intra-articular steroids within 28 days randomization
use of any investigational medication within 28 days randomization or 5 half-lives whichever is longer
clinically significant abnormality on ECG at screening
high risk factors for HIV or hepatitis B or C
history of malignancy within 5 years (except basal cell skin carcinomas and/or fewer than 3 treated squamous cell skin carcinomas
evidence of skin conditions at screening that would interfere with evaluations of psoriasis