E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 4.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050577 |
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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 classify patients suffering from plaque psoriasis responding to a given treatment based upon reduction in Psoriasis Area and Severity Index (PASI), Psoriasis Disability Index (PDI) and Dermatology Life Quality Index (DLQI). |
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E.2.2 | Secondary objectives of the trial |
* Characterize patients suffering from plaque psoriasis responding to or not responding to subcutaneous administered efalizumab treatment. * Estimate time until response of subcutaneous administered efalizumab treatment in patients suffering from plaque psoriasis. * Estimate the prevalence and the time until exacerbation of symptoms in patients classified as responders to subcutaneous administered efalizumab treatment for plaque psoriasis.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
"The study population consists of patients of both genders, over the age of 18 years who have been suffering from stable moderate to severe plaque psoriasis for more than six months and who are eligible for efalizumab treatment according to current national guidelines, i.e. the patients have not responded to, have contraindications to or are intolerant to other systemic treatment, including cyklosporin, methotrexat and PUVA." |
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E.4 | Principal exclusion criteria |
* Pregnant or breast-feeding patients. * Patients with a history of uncontrolled bacterial, viral, fungal or atypical mycobacterial infection. * Patients suffering from HIV, hepatitis B and C, active tuberculosis (TB) or currently undergoing treatment for TB, hepatic cirrhosis and hospital admission for cardiac disease, stroke or pulmonary disease within last year. * Patients with history of cancer in the preceding 5 years, including lymphproliferative disorders. Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled. * Patients to whom subcutaneous administered efalizumab treatments are contraindicated.
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E.5 End points |
E.5.1 | Primary end point(s) |
The three basic variables in the project are PASI, PDI and DLQI. Based on the PASI registration, PASI-25, 50 and 75 will be recorded and the patient classified as non-responder, possible responder or responder to the given treatment. |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
Classification of responders |
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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 | No |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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 | 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 | 4 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 9 |