NCT00422617

Brief Summary

An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

Shorter than P25 for not_applicable

Status
completed

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

January 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
Last Updated

January 17, 2007

Status Verified

September 1, 2004

First QC Date

January 16, 2007

Last Update Submit

January 16, 2007

Conditions

Chronic Plaque Psoriasis

Keywords

psoriasisalefacept

Outcome Measures

Primary Outcomes (1)

  • To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE

Secondary Outcomes (1)

  • To determine TRR50, Quality of Life (QOL), the safety and tolerability

Interventions

Alefacept (Amevive)DRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must give written informed consent
  • Must be \>= 16 years of age
  • Must have been diagnosed with chronic plaque psoriasis at least one year and require systemic or phototherapy
  • Must have CD4+ lymphocyte count at or above the lower limit of normal
  • Must have a BSA \>= 10%

You may not qualify if:

  • Current erythrodermic, generalized pustular, or guttate psoriasis
  • Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
  • History of any clinical significant disease that would be contraindicated for this study as determined by the investigator
  • Prior history of systemic malignancy, untreated localised skin canceer or a \>10 squamous cell carcinoma
  • Current enrollment in any other investigational drug study within 30 days prior to study drug administration
  • Treatment with systemic immunosuppressant agents within the 4 weeks prior to study drug administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

Alefacept

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CD58 AntigensMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesImmunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMembrane ProteinsRecombinant Fusion ProteinsRecombinant Proteins

Study Officials

  • Po-Han Huang

    CGMH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 16, 2007

First Posted

January 17, 2007

Study Start

January 1, 2005

Study Completion

November 1, 2005

Last Updated

January 17, 2007

Record last verified: 2004-09