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

• Conditions: Psoriasis Subjects with Psoriatic Arthritis

• Registration Number: EUCTR2005-001533-15-HU
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-25
• Last Update Posted: 18 April 2012

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:
- 2 swollen joints and 2 tender/painful joints for at least 3 months at screening and baseline, or
- Sacroiliitis or spondylitis in at least 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 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.
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. Hot, red, joint not evaluated by a rheumatologist as PsA.

Study & Design

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