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Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00184366
Recruitment Status : Terminated (efalizumab was withdrawn from market; full 2 years follow-up only 14 patients)
First Posted : September 16, 2005
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Plaque Psoriasis Drug: 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 Type : Observational
Actual Enrollment : 96 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Classification and Characterization of Patients Suffering From Moderate to Severe Plaque Psoriasis Responding to Subcutaneous Administered Efalizumab
Study Start Date : May 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis


Intervention Details:
  • Drug: efalizumab
    efalizumab


Primary Outcome Measures :
  1. Response PASI 75 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Dermatology Life Quality index (DLQI) [ Time Frame: 2 years ]
  2. Psoriasis disability Index (PDI) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients of both genders, over the age of 18 years who have been suffering from moderate to severe plaque psoriasis for more than six months and who are eligible for efalizumab treatment according to current Norwegian guidelines.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184366


Locations
Norway
Dep of dermatology, St Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Chair: Morten Dalaker, univ lekt II St Olavs hospital, NTNU, Norway

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184366     History of Changes
Other Study ID Numbers: ROCAC
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by Norwegian University of Science and Technology:
drug therapy
efalizumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs