A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

Psoriasis Clinical Trial

Official title:

An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab Followed by Efalizumab Taper in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109252
• Other study ID #: ACD2391g
• Status: Completed
• Phase: Phase 3
• First received: April 26, 2005
• Last updated: June 19, 2013
• Start date: January 2002
• Est. completion date: April 2003

Study information

• Verified date: June 2013
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Raptiva (efalizumab)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.