NCT00109252

Brief Summary

This is an open-label, multicenter study designed to evaluate the efficacy and safety of efalizumab administered at weekly SC (subcutaneous) doses of 1.0 mg/kg followed by efalizumab taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2002

Shorter than P25 for phase_3

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, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2005

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 26, 2005

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

First QC Date

April 26, 2005

Last Update Submit

June 19, 2013

Conditions

Psoriasis

Keywords

Plaque PsoriasisTopical

Interventions

Raptiva (efalizumab)DRUG

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • Previous participation in Study ACD2390g
  • For women of childbearing potential, continued use of an acceptable method of contraception for the duration of their participation in the study
  • Willingness to continue to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources throughout the study

You may not qualify if:

  • Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to efalizumab
  • Systemic therapy for psoriasis (ET Day 0 through FU Day 84 or upon relapse or unusual presentation of psoriasis in the FU period, whichever occurs first)
  • Systemic immunosuppressive drugs for other indications (ET Day 0 through FU Day 84)
  • Topical therapies for psoriasis (ET Day 0 through ET Day 84)
  • Live virus or bacteria vaccines (ET Day 0 through FU Day 84)
  • Other vaccines or allergy desensitization (it is recommended that these be scheduled after FU Day 84)
  • Other experimental drugs or treatments (ET Day 0 through FU Day 84)
  • Beta-Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between ET Day 0 and TT Day 84)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases
0

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2005

First Posted

April 26, 2005

Study Start

January 1, 2002

Study Completion

April 1, 2003

Last Updated

June 21, 2013

Record last verified: 2013-06