A Randomised, Double-Blind, Two-Period Study to Evaluate the Safety and Efficacy of Etanercept on Skin and Joint Disease in Psoriasis Subjects with Psoriatic Arthritis - PRESTA

Conditions: PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS
MedDRA version: 6.1Level: PTClassification code 10037153

Registration Number: EUCTR2005-001533-15-IT

Lead Sponsor: Global Medical Affairs, Wyeth Research Division of Wyeth Pharmaceuticals Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1.18 years of age or older at time of consent 2.Active PsA defined by the following criteria 8805; 2 swollen joints and 8805; 2 tender/painful joints for at least 3 months at screening and baseline, or sacroiliitis or spondylitis in 8805; 1 joint documented by radiograph Negative serum rheumatoid factor within 6 months of screening Note A rheumatologist should establish the diagnosis of PsA if possible. Radiographs of the hands, feet, or lumbar spine/pelvis may be used to help establish the diagnosis3.Clinically stable, plaque psoriasis involving 8805; 10 body surface area BSA and PGA of Psoriasis status of moderate or worse moderate, marked, or severe at screening and baseline. 4. Negative serum pregnancy test taken at screening in all women excpept those who were surgically sterile or at least 1 year postmenopausal. 5.Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study. 6.Ability to self-inject drug or have a designee who can do so. 7.Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed. 8.Ability to store injectable test article at 2o C to 8o C
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis 2.PUVA, cyclosporine, alefacept Amevive , efalizumab Raptiva , anakinra Kineret or any other systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation 3.UVB therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin within 14 days of study drug initiation 4.Prior exposure to any TNF-inhibitor, including etanercept 5.Corticosteroid dose of prednisone 10 mg/day or equivalent or change in dose within 28 days of baseline 6.Receipt of intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid injection within 28 days of screening and during the study 7.Dose of NSAID changed within 14 days of baseline 8.Hot, red, joint not evaluated by a rheumatologist as PsA 9.Abnormality in haematology or chemistry profiles haemoglobin 8804; 85 g/L; haematocrit 8804; 27 ; platelet count 8804; 125 x 109 /L; white blood cell count 8804; 3.5 x 109 /L; serum creatinine 8805; 175 mmol/L; aspartate aminotransferase AST SGOT and alanine aminotransferase ALT SGPT 8805; 2 times the laboratory s upper limit of normal 10.Significant concurrent medical events including Uncontrolled hypertension Myocardial infarction within 12 months of the screening visit Unstable angina pectoris Class III or IV congestive heart failure as defined by the New York Heart Association or uncompensated congestive heart failure Hunt 2001 Severe pulmonary disease requiring hospitalisation or supplemental oxygen Diagnosis of multiple sclerosis or other central demyelinating diseases Presence or history of confirmed blood dyscrasias Uncontrolled diabetes mellitus Rheumatoid arthritis, systemic lupus erythematosus, gout, scleroderma, or polymyositis Cancer or history of cancer Serious infection infection associated with hospitalisation and/or intravenous antibiotics within 1 month of test article administration or active infection at screening Open cutaneous ulcers Known human immunodeficiency virus HIV , hepatitis B surface antigen HBsAg , or hepatitis C virus HCV positive Tuberculosis TB infection Any condition that, in the investigator s judgment, might cause this study to be detrimental to the subject 11.Receipt of any live attenuated vaccine within 4 weeks prior to baseline 12.Known contraindication or hypersensitivity to etanercept or its excipients 13.Pregnant or breast-feeding women 14.Reasonable expectation that the subject will not be able to satisfactorily complete the study 15.History of or current psychiatric illness that would interfere with the subject s ability to comply with protocol requirements or give informed consent 16. History of alcohol or drug abuse that would interfere with the subject s ability to comply with protocol requirements 17.Receipt of any investigational drug within 3 months of screening visit 18.Employment by the investigator or reporting directly or indirectly to the investigator PLEASE REFER TO PROTOCOL FOR MORE DETAILS.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method