Status:
COMPLETED
A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g
Lead Sponsor:
Genentech, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00109252
Start Date
January 1 2002
End Date
April 1 2003
Last Update
June 21 2013
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