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Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

This study has been terminated.
(efalizumab was withdrawn from market; full 2 years follow-up only 14 patients)
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184366
First received: September 13, 2005
Last updated: January 18, 2012
Last verified: January 2012
History of Changes

September 13, 2005
January 18, 2012
May 2005
May 2008   (final data collection date for primary outcome measure)
Response PASI 75 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Response PASI 75
Complete list of historical versions of study NCT00184366 on ClinicalTrials.gov Archive Site
  • Dermatology Life Quality index (DLQI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Psoriasis disability Index (PDI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Dermatology Life Quality index (DLQI)
  • Psoriasis disability Index (PDI)
Not Provided
Not Provided
 
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

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.
Plaque Psoriasis
Drug: efalizumab
efalizumab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
96
July 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00184366
ROCAC
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Not Provided
Study Chair: Morten Dalaker, univ lekt II St Olavs hospital, NTNU, Norway
Norwegian University of Science and Technology
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP