E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 find out the dynamics of cell biological changes in lesional skin during treatment with adalimumab. |
|
E.2.2 | Secondary objectives of the trial |
To find out whether adalimumab treatment results in - a reduction of T cell subsets, - normalization of proliferation and differentiation characteristics and - a reduction of parameters for innate immunity
To find out the order in which the above mentioned parameters show an alteration.
To correlate the alteration of cell biological parameters with clinical improvement. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects 18 years of age or older who have moderate to severe plaque psoriasis, as defined by PASI score ≥ 10 or PASI score ≥ 8 AND Skindex total score > 35 at the baseline (week 0) visit. Patients have failed, are intolerant or have contraindications to methotrexate, PUVA and cyclosporin. |
|
E.4 | Principal exclusion criteria |
•Known history of allergic reaction or significant hypersensitivity to the constituents of adalimumab. •Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies which must be discontinued at least 12 weeks prior to enrolment. •Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only. •Use of PUVA for at least 4 weeks prior to Baseline. •Use of oral or injectable corticosteroids for at least 4 weeks prior to Baseline and during the study. •Use of medication which may aggravate psoriasis: β blockers, antimalaria drugs, NSAID and lithium carbonate. •Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline. •Other active skin diseases or skin infections (bacterial, viral or fungal) that may interfere with evaluation of psoriasis. •History of listeriosis, histoplasmosis, untreated TB, persistent chronic infections. •Recent active infections requiring hospitalization or treatment with intravenous (IV) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit. •Immune deficiency, history of HIV or is immunocompromised. •Use of anti-retroviral therapy. •Positive Hepatitis B or C (previous infection). •History of neurologic symptoms suggestive of central nervous system demyelinating disease. •Malignancies other than successfully treated non-metastatic cutaneous squamous cell of basal cell carcinoma, or cervical carcinoma in situ. •Erythrodermic, generalized pustule, new onset guttate, or medication-related or exacerbated psoriasis vulgaris. •Subject has a poorly controlled medical condition. •Female subject who is pregnant or breast-feeding or has positive serum pregnancy test at screening or considering becoming pregnant during the study or within 5 months after the last dose of adalimumab. •History of keloid formation following wounding. •Investigator considers the subject unsuitable for adalimumab for any reason. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The PASI score at all visits and cell biological parameters in the punch biopsies for T cells, innate immunity and epidermal proliferation. |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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
|
The end of the study is defined as a half year after the last patient’s last visit. At that time the biopsies will have been analysed. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |