Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

Norwegian University of Science and Technology96 enrolled

Overview

The main objectives of the project are: * To classify patients suffering from plaque psoriasis responding on a given treatment (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI) * To characterize patients suffering from plaque psoriasis responding to or not responding to subcutaneous administrated efalizumab.

This is an investigator initiated,prospective, longitudinal, observation study. Before starting treatment with efalizumab we will record factors such as demographic data, type of psoriasis, previous treatment, other diseases etc. We will follow the patients and classify them as responders and non-responders. We hope to find 4-5 factors which we can use later to predict response of this drug.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Plaque Psoriasis

Interventions

efalizumabDRUG

efalizumab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * moderate to severe plaque psoriasis for more than six months * eligible for efalizumab treatment according to current Norwegian guidelines 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 or C, active tuberculosis, 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 lymphoproliferative disorders. patients with history of fully resolved basal cell or squamous cell skin cancer may be enrolled. * Patients with impaired renal or hepatic function.

Locations (1)

Dep of dermatology, St Olavs Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

Response PASI 75

Time frame: 2 years

Secondary Outcomes

Dermatology Life Quality index (DLQI)

Time frame: 2 years

Psoriasis disability Index (PDI)

Time frame: 2 years

Data from ClinicalTrials.gov

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