An open label study of humira (adalimumab)in the treatment of patients with severe psoriasis - Open label study of humira in patients with severe psoriasis version 1

Phase 1

• Conditions: Psoriasis; MedDRA version: 8.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2006-004260-31-GB
• Lead Sponsor: HL NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-04
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of humira in the treatment of severe recalcitrant psoriasis in 20 patients.;Secondary Objective: To evaluate the safety of humira in the treatment of severe recalcitrant psoriasis.;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.<br>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).<br>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.<br>The adverse events data will also be evaluated<br>