Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

Norwegian University of Science and Technology

Status: Terminated

Conditions: Plaque Psoriasis

Treatments: Drug: efalizumab

Study type: Observational

Funder types: Other

Identifiers

NCT00184366

ROCAC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.