E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque psoriasis |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of etanercept 50 mg once weekly for 24 weeks and etanercept 50 mg twice weekly for 12 weeks followed by etanercept 50 mg once weekly for 12 weeks in treating the skin manifestations of psoriasis in subjects with moderate to severe psoriasis when used with adjunctive topical therapy as needed.
The primary hypothesis is that etanercept 50 mg once weekly will provide a Psoriasis Area and Severity Index (PASI) 75 response (75% improvement from baseline in PASI) of at least 50% at week 24 when used with adjunctive topical therapy as needed. The conditional primary hypothesis is that etanercept 50 mg twice weekly followed by etanercept 50 mg once weekly will provide a PASI 75 response of at least 60% at week 24 when used with adjunctive topical therapy as needed.
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E.2.2 | Secondary objectives of the trial |
1. To assess the impact of 2 different treatment regimens of etanercept on quality of life and pharmacoeconomic outcomes through 24 weeks in subjects with moderate to severe psoriasis. 2. To assess the cardiovascular risk profile for subjects with moderate to severe psoriasis. 3 To assess the safety of the 2 different treatment regimens of etanercept through 24 weeks in subjects with moderate to severe psoriasis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 18 years of age or older at time of consent. 2. Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving > 10% body surface area (BSA) or PASI >=10 3. In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for one of the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy. |
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E.4 | Principal exclusion criteria |
1. Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. 2. Any rheumatologic disease such as rheumatoid arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma, polymyositis, or associated syndromes. 3. Subject has had previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF-α) inhibitors, or other biologic agents. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving a 75% improvement from baseline in PASI score at week 24 when used with adjunctive topical therapy as needed. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Period 1 is Double Blind and Period 2 is Open label. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |