Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

Terminated

• Conditions: Plaque Psoriasis

• Registration Number: NCT00184366
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2008-05
• Study Completion: 2008-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response PASI 75	2 years

Secondary Outcome Measures

Name	Time	Method
Dermatology Life Quality index (DLQI)	2 years
Psoriasis disability Index (PDI)	2 years

Trial Locations

Locations (1)

Dep of dermatology, St Olavs Hospital; 🇳🇴 Trondheim, Norway