E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriasis vulgaris (Plaque-Typ) |
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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 | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
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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 |
There is no data on the interplay of etanercept and UVB treatment with regard to photo-cocarcinogenicity and efficacy in psoriasis.3 In this two part study, we aim I) to investigate the acute impact of etanercept on UVB-induced inflammation, DNA damage and apoptosis (Part 1), and II) to evaluate the benefits from combined treatment in psoriasis using etanercept and narrowband UVB (NB-UVB, Part 2). |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients eligible for etanercept treatment according to SPC and local guidelines and regulations - Patients ages 18 or older - Psoriasis vulgaris (Plaque-Typ) - given indication of therapy with Etanercept |
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E.4 | Principal exclusion criteria |
- Pregnancy or nursing mothers - Patients with severe cardio-respiratory insufficiency - known photodermatosis (for example: urticaria solaris) - known genodermatosis with increased UV-sensitivity - intake of photosensitizing drugs - allergy to local anesthetics - anamnesis of wound healing disorders or keloids - skin cancer in the presence or in the past - systemic immunsuppressive therapy - significant UV-exposure 3 months before the beginning of the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Part 1 Primary outcome - scores of immunohistochemistry for thymine dimers, p53, p21 (DNA damage and cell cycle regulation), CD1a (Langerhans cells), CD3 and CD4 (T lymphocytes), CD95/FAS ligand, Bcl-2 and TUNNEL (apoptosis), interleukine 8 and 10 (inflammatory cytokines).Secondary outcome – objective quantification of UVB-induced erythema (inflammation) using colorimetry (Minolta, Osaka, Japan). Quantitative data of real-time RT-PCR of cytokines etc.
Part 2 Primary outcome – modified psoriasis area and severity index of two comparable marker lesions (one irradiated, one non-irradiated); Secondary outcome – 20-MHz ultrasound of marker lesions; scores of immunohistochemistry for CD1a (Langerhans cells), CD3 and CD4 (T lymphocytes), CD95/FAS ligand, Bcl-2 and TUNNEL (apoptosis), interleukine 8 and 10 (inflammatory cytokines). Quantitative data of real-time RT-PCR of cytokines etc.
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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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
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 | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
UV-exposed versus non-UV-exposed skin |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |