A Study to Evaluate Raptiva in Combination With Topical Psoriasis Therapies

NCT00096980 | Completed Phase 4

• 1 other identifier: ACD2243g
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an open label, randomized, multicenter study designed to compare the efficacy of 12 weeks of subcutaneously administered efalizumab (monotherapy) with that of combination therapy (Efalizumab and a topical corticosteroid ointment) in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. The study will also evaluate the safety and tolerability of 30 months of continuous efalizumab treatment in those subjects who derive benefit from the initial 12 weeks of treatment.

Conditions

Psoriasis

Interventions

Raptiva (efalizumab) DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Diagnosis of plaque psoriasis for \>=6 months
• A minimum Psoriasis Area and Severity Index (PASI) score of 12.0 at screening
• Plaque psoriasis covering \>=10% of total Body Surface Area (BSA)
• In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or who has received prior systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil \[MMF\], thioguanine, hydroxyurea, sirolimus, azathioprine, 6 MP, etanercept)
• to 70 years old

You may not qualify if:

• Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
• Clinically significant psoriasis flare during the 3 months prior to enrollment
• Pregnancy or lactation
• History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
• History of opportunistic infections (e.g., systemic fungal infections, parasites)
• Seropositivity for hepatitis B or C virus
• Seropositivity for human immunodeficiency virus (HIV)
• History of active tuberculosis (TB) or currently undergoing treatment for TB
• Presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
• Diagnosis of hepatic cirrhosis, regardless of cause or severity
• Hospital admission for cardiovascular or pulmonary disease within the last year
• History of substance abuse within the last 5 years
• History of severe allergic or anaphylactic reactions to monoclonal antibodies or fusion proteins, which contain an immunoglobulin (Ig) Fc region (e.g., etanercept, LFA3TIP)
• History of severe allergic reactions to or intolerance of topical corticosteroid therapies
• Previous treatment with efalizumab

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (1)

• Lamerson C, Stevens G, Sax K. Treatment of nail psoriasis with efalizumab: a preliminary study. Cutis. 2008 Sep;82(3):217-20.

  PMID: 18856162 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2004
• First Posted: November 18, 2004
• Study Start: February 1, 2001
• Study Completion: May 1, 2004
• Last Updated: June 21, 2013

Record last verified: 2013-06