Psoriasis Subjects with Psoriatic Arthritis
Conditions
Interventions
Trade Name: Enbrel (etanercept)
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Injection*
INN or Proposed INN: Etanercept
Current Sponsor code: 0881
Other descriptive name: TNR-001
rhuTNFR:Fc
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 50-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous u
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of two different treatment regimens of etanercept in treating the skin manifestations of psoriasis subjects with PsA over 12 weeks. The study hypothesis is that etanercept 50 mg BIW will demonstrate superior clinical efficacy, as determined by the proportion of subjects achieving a Physician Global Assessment (PGA) of Psoriasis of clear or almost clear at 12 weeks, compared with etanercept 50 mg QW in the treatment of psoriasis.;Secondary Objective: 1. To compare the efficacy of two different treatment regimens of etanercept in treating the skin manifestations over 24 weeks. 2. To compare the efficacy of two different treatment regimens of etanercept on joint disease over 12 and 24 weeks. 3. To compare the impact of two different treatment regimens of etanercept on quality of life and pharmacoeconomic outcomes over 12 and 24 weeks. 4. To evaluate the time course of treatment response to two different treatment regimens of etanercept. 5. To evaluate the safety and tolerability of two different treatment regimens of etanercept.;Primary end point(s): Proportion of subjects achieving a status on the PGA of psoriasis of clear or almost clear at Week 12. | — |
Countries
Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed