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

This study has been completed.

First Received: April 26, 2005 Last Updated: June 23, 2005 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00109252

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: Raptiva (efalizumab)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Efalizumab

U.S. FDA Resources

Further study details as provided by Genentech:

Estimated Enrollment:

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Study Results This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	ACD2391g
Study First Received:	April 26, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00109252 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Plaque Psoriasis
Topical

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 09, 2009