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

NCT ID: NCT00109252

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Raptiva (efalizumab)

Intervention Type DRUG

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ACD2391g

Identifier Type: -

Identifier Source: org_study_id

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