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Sponsored by: |
Universita di Verona |
Information provided by: | Universita di Verona |
ClinicalTrials.gov Identifier: | NCT00707070 |
It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.
Condition | Intervention | Phase |
Chronic Plaque Psoriasis |
Drug: efalizumab plus placebo Drug: efalizumab plus acitretin |
Phase IV |
MedlinePlus related topics: | Cholesterol Psoriasis |
Drug Information available for: | Efalizumab Acitretin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis |
Estimated Enrollment: | 100 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral
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Drug: efalizumab plus acitretin
1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day
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2: Placebo Comparator
efalizumab 1 mg/Kg/week subcutaneous plus oral placebo
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Drug: efalizumab plus placebo
1 mg/kg/week subcutaneous for 24 weeks
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Giampiero Girolomoni, Prof | 39-045-812-2547 ext 0039 | giampiero.girolomoni@univr.it |
Italy | |||||
Univeristy Hospital | |||||
Verona, Italy, 37126 |
Universita di Verona |
Principal Investigator: | Giampiero Girolomoni | University of Verona |
Principal Investigator: | Giampiero Girolomoni | University of Verona |
Responsible Party: | University of Verona ( Giampiero Girolomoni ) |
Study ID Numbers: | Gisondi 2, No grants were received |
First Received: | June 26, 2008 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00707070 |
Health Authority: | Italy: Ethics Committee |
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