A Study of Efalizumab in Patients With Moderate to Severe Chronic Psoriasis Who Have Failed, Have a Contraindication to, or Are Intolerant of Other Systemic Therapies
Phase IIIb/IV , open-label, multi-centre study in patients receiving efalizumab 1mg/kg/week for 12 weeks.
At anytime during the first 12 weeks, non-responding or worsening patients will discontinue efalizumab and enter a 12-week treatment period with other approved antipsoriasis therapies.
- To establish safe psoriasis control of moderate to severe chronic plaque psoriasis with efalizumab in patients who have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate and PUVA.
- To evaluate the management of psoriasis events namely rebound and exacerbation, in patients while on Efalizumab or subsequent to its discontinuation
|Psoriasis||Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Multicentre, Open Label Phase IIIb Study of Subcutaneously Admin. Efalizumab (Adult Patients) With Moderate to Severe Chronic Psoriasis Failed to Respond to, or Have a Contraindication to, or Are Intolerant of Other Systemic Therapies Incl. Cyclosporine, Methotrexate and PUVA.|
- To establish control of moderate to severe chronic plaque psoriasis with efalizumab in patients who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA. [ Time Frame: 12 Weeks ]
- To evaluate the management of psoriasis events, namely rebound and exacerbation (psoriasis flare-ups) in patients while i) on efalizumab therapy and ii) subsequent to its discontinuation. [ Time Frame: 24 Weeks ]
|Study Start Date:||December 2004|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody
Each subject will receive 12 doses of 1 mg/kg/week during a period of 12 weeks. Depending on the response at 12 weeks patients might receive additional 8 to 12 weekly injections at 1.0 mg/kg/week.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249808
|Feltham, United Kingdom|
|Study Director:||Daiana Licu, MD||Sponsor GmbH|