A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g

Psoriasis Clinical Trial

Official title:

An Open Label, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096603
• Other study ID #: ACD2601g
• Status: Completed
• Phase: Phase 3
• First received: November 12, 2004
• Last updated: March 19, 2014
• Start date: October 2002
• Est. completion date: July 2004

Study information

• Verified date: March 2014
• 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 safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with plaque psoriasis who previously participated in Study ACD2600g.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Previous participation in Study ACD2600g

• For women of childbearing potential, continued use of an acceptable method of contraception for the duration of the study

Exclusion Criteria:

• Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to Efalizumab

Study Design

Endpoint Classification: Safety Study, 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.