Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

Classification and Characterization of Patients Suffering From Moderate to Severe Plaque Psoriasis Responding to Subcutaneous Administered Efalizumab

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00184366

Enrollment

Registered

2005-09-16

Start date

2005-05-31

Completion date

2008-07-31

Last updated

2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Keywords

drug therapy, efalizumab

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.

Interventions

DRUGefalizumab

efalizumab

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Response PASI 75	2 years

Secondary

Measure	Time frame
Dermatology Life Quality index (DLQI)	2 years
Psoriasis disability Index (PDI)	2 years

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026