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

Information source: Genentech, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Raptiva (efalizumab) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Genentech, Inc.

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.

Clinical Details

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

Study design: Masking: Open Label, Primary Purpose: Treatment

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Additional Information

Starting date: January 2002
Last updated: June 19, 2013

Page last updated: August 23, 2015

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