E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
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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 estimate the Nail Psoriasis Severity Index (NAPSI) in the target fingernail for both treatment regimens over 24 weeks |
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E.2.2 | Secondary objectives of the trial |
To estimate: the overall NAPSI for both treatment regimens over 24 weeks; the proportion of patients achieving a 50% and 75% improvement in NAPSI in the target fingernail and overall NAPSI at 12 and 24 weeks; the Psoriasis Area and Severity Index (PASI) scores over 24 weeks;the proportion of patients achieving a 50% and 75% improvement in PASI scores at 12 and 24 weeks;the Physician Global Assessment (PGA) of Psoriasis over 24 weeks;the proportion of subjects achieving a status on the PGA of Psoriasis of clear or almost clear over 24 weeks;the proportion of subjects achieving a status on the PGA of Psoriasis of mild or better over 24 weeks;patient Dermatology Life Quality Index (DLQI) over 24 weeks;Physician and Patient Assessment of Nail Psoriasis Activity Visual Analogue Scale (VAS) over 24 weeks;the safety and tolerability of the treatment regimens over 24 weeks;To explore the utility of a novel fingernail grading assessment tool over 24 weeks |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.18 years of age or older at time of consent 2.Active, stable plaque psoriasis defined by the following criteria: Body surface area (BSA) >= 10 % at screening and baseline Or, PASI >10 at screening and baseline Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline Or, DLQI > 10 at baseline 3.Active fingernail psoriasis as defined as target fingernail NAPSI >= 2 and overall NAPSI > 14 Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator. 4.Failure of at least one systemic psoriasis therapy for nail psoriasis 5.Eligible to receive biologic therapy for psoriasis in accordance to local guidelines |
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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.Psoralen plus ultraviolet A radiation (PUVA), cyclosporine, alefacept (Amevive), methotrexate, acitretin or any other systemic anti-psoriasis therapy within 28 days of study drug initiation 3.Prior exposure to any TNF-inhibitor, including ETN. Prior exposure to efalizumab (RaptivaTM) is also prohibited. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in NAPSI for target fingernail over 24 weeks |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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 | 4 |
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 | 4 |