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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00336973 |
This is a Phase IV open-label study to evaluate the efficacy and safety of SC efalizumab in adult subjects (18 years of age and older) with chronic moderate or worse plaque psoriasis who have had an inadequate response to treatment with an anti-TNF agent. The study will consist of a screening period, a treatment period, and an observation period. All subjects will begin in the screening period (the length of which is dependent on the previous anti-TNF agent treatment). Approximately 100 eligible subjects will receive treatment from Day 0 through Day 168.
Condition | Intervention | Phase |
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Psoriasis |
Drug: efalizumab |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Phase IV Open-Label Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Raptiva (Efalizumab) in Adult Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent |
Enrollment: | 77 |
Study Start Date: | May 2006 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: efalizumab
Subcutaneous repeating dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | ACD3780g |
Study First Received: | June 13, 2006 |
Last Updated: | September 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00336973 |
Health Authority: | United States: Institutional Review Board |
Plaque Psoriasis Raptiva Anti-TNF |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |