NCT00184366

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

January 18, 2012

Conditions

Plaque Psoriasis

Keywords

drug therapyefalizumab

Outcome Measures

Primary Outcomes (1)

  • Response PASI 75

    2 years

Secondary Outcomes (2)

  • Dermatology Life Quality index (DLQI)

    2 years

  • Psoriasis disability Index (PDI)

    2 years

Interventions

efalizumabDRUG

efalizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • moderate to severe plaque psoriasis for more than six months
  • eligible for efalizumab treatment according to current Norwegian guidelines

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep of dermatology, St Olavs Hospital

Trondheim, 7006, Norway

Location

MeSH Terms

Interventions

efalizumab

Study Officials

  • Morten Dalaker, univ lekt II

    St Olavs hospital, NTNU, Norway

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

May 1, 2005

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

NO(1)