E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with moderate to severe plaque psoriasis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
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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 demonstrate the sustained efficacy and safety of etancercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin |
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E.2.2 | Secondary objectives of the trial |
PASI Area Under the Curve (AUC) between randomization and week 24 Change in PGA score from randomization to week 24 % Relapse (loss of 50% improvement in PASI) and time to relapse during the 24 weeks after randomization % Improvement in PASI score from randomization week 24 Change in DLQI from randomization to week 24 Safety -%Adverse events (AEs) -Rebound effects (worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants, such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy) Both parameters will be assessed before randomization, in the combination period (of ETN and Cs 6 weeks taper) and during the 24 weeks after randomization. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- age between 18 and 70 years - BSA >10% or PASI >10 - Negative result of b-HCG - Sexually active men and women participating in the study must use a medically acceptable form of contraception that needs to be continued for 3 months following discontinuation of ciclosporin - Ability to inject study drug subcutaneously - Ability to store injectable test article at 2C to 8C |
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E.4 | Principal exclusion criteria |
- Evidence of skin conditions (eg, eczema) other than psoriasis - Psoralen plus ultraviolet A radiation (PUVA), ciclosporin, acitretin, alefacept (Amevive), anakinra (Kineret) or any other systemic anti-psoriasis therapy or disease modifying antirheumatic drug (DMARD) within 28 days of screening - Ultraviolet B radiation (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin within 14 days of screening - Prior exposure to any TNF-inhibitor, including ETN. Prior exposure to efalizumab (Raptiva) is also prohibited - Corticosteroid dose of prednisone >10 mg/day (or equivalent) or change in dose within 28 days of screening - Serious infection between 28 days before the screening visit - Abnormal hematology or chemistry - Receipt of any live (attenuated) vaccine within 4 weeks prior to randomization - Pregnant or breast-feedingwomen - Significant concurrent medical conditions at the time of screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of change in PASI score from randomization to week 24 (week 18 of ETN)Placebo monotherapy. |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |