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

• Registration Number: EUCTR2005-001533-15-DE
• Lead Sponsor: Global Medical Affairs, Wyeth Research Division of Wyeth Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-20
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

These are main inclusion criteria. Please refer to the protocol for the complete list.
1. 18 years of age or older at time of consent.
2. Active PsA defined by the following criteria:
• =(greater than or equal to) 2 swollen joints and =(greater than or equal to) 2 tender/painful joints at screening and baseline
• Patient reported joint pain for at least 3 months prior to screening
• 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 diagnosis.
3. Clinically stable, plaque psoriasis involving at least 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 except those who were surgically sterile or at least 1 year postmenopausal. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives
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 2 C to 8 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

These are main inclusion criteria. Please refer to the protocol for the complete list.
1. Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
2. Psoralen plus ultraviolet A radiation (PUVA), cyclosporine, alefacept (Amevive™), efalizumab (Raptiva™), anakinra (Kineret™) or any other systemic anti-psoriasis therapy within 28 days study drug initiation (Exception: methotrexate [MTX] and acitretin - see concomitant treatment section of protocol).
3. Ultraviolet B radiation (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin within 14 days of study drug initiation (exception: topical steroids at no higher than moderate strength, are permitted on scalp, axillae, and groin but dose and formulation must remain stable throughout study).
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 nmt 85 g/L; haematocrit nmt 27%; platelet count nmt 125 x 10 power 9 /L; white blood cell count nmt 3.5 x 10 power 9 /L; serum creatinine nlt 175 mmol/L; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) nlt 2 times the laboratory’s upper limit of normal.
10. Significant concurrent medical events including:
·Uncontrolled hypertension (defined as screening systolic blood pressure > 160 mm Hg or screening diastolic blood pressure > 100 mm Hg)
·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 (Note: follow local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy)
·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 al

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified