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 | 8.1 |
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 evaluate the efficacy of humira in the treatment of severe recalcitrant psoriasis in 20 patients. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of humira in the treatment of severe recalcitrant psoriasis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patients aged 18 - 80 years 2.Patients with severe psoriasis, defined as a PASI of 10 or more or involvement of 10% or more of body surface area, who are unresponsive/intolerant/have contraindications to ultraviolet light therapy and at least 3 other second line therapies. 3.Patients who provide written informed consent. 4.Patients who are not currently receiving oral therapy or phototherapy for their psoriasis, and have not received any of these treatments within the previous 28 days. 5.Females of childbearing potential who provide a negative urine pregnancy test and are willing to use adequate contraception for the duration of the treatment and for at least 5 months after discontinuation of treatment. 6.Sexually active males who are willing to use adequate contraception for the duration of the study.
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E.4 | Principal exclusion criteria |
1.Pregnant or breast-feeding females. 2.Patients with current or previous recurrent infections, including hepatitis, chronic leg ulcers, recurrent cellulitis and persistent or recurrent chest infections. There have been reports of serious infections in patients on humira. 3.Patients with active or latent tuberculosis (TB) There have been reports of development or reactivation of TB in patients treated with humira. 4.Patients with an abnormal chest x-ray. 5.Patients over the age of 65 years, or diabetics who have not been vaccinated against influenza and pneumococcus, because of the increased risk of infection in such patients. 6.Patients who are Hepatitis B or C positive. The safety of TNF antagonists in patients with chronic hepatitis is not known. 7.Patients with significantly abnormal liver function tests. Humira can cause abnormalities of liver function tests. 8.Patients who are HIV positive. 9.Patients with current or previous malignancy, excepting non-melanoma skin cancer. In clinical trials of TNF antagonists in patients with rheumatoid arthritis, more cases of lymphoma were observed compared with controls. However there is an increased background lymphoma risk in patients with rheumatoid arthritis, but these data cannot exclude a possible risk of malignancy in patients treated with humira. 10.Patients with pre-existing or recent onset of demyelinating disorders. Humira has been associated, in rare cases, with exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease, such as multiple sclerosis. 11.Patients with signs and symptoms of heart failure (New York Heart Association grade 3 or 4). Humira has been associated with the development or exacerbation of heart failure. 12.Patients who have significant hypercholesterolaemia. Humira can cause hypercholesterolaemia. 12.Patients who have any condition which would interfere with their ability to participate in the study. 14.Patients who are unable to read or understand the informed consent or follow verbal and/or written instructions.
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E.5 End points |
E.5.1 | Primary end point(s) |
The principal endpoint will be the absolute percentage area of involvement of <5%. In patients who have failed on all other therapies a small area of involvement is a highly meaningful outcome. Secondary endpoints will be the change in the PASI score between baseline and the end of the treatment period (12 months) and between baseline and the end of the study period (24 months). Further secondary endpoints will be the change in the PGA and the change in the mean DLQI and PDI scores at the end of the treatment (12 months) and study (24 months) periods. The adverse events data will also be evaluated
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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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 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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The end of the trial will be the last visit of the last patient to enter 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |