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Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis

NCT00707070 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-06-30

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Plaque Psoriasis

Interventions

DRUG

efalizumab plus placebo

1 mg/kg/week subcutaneous for 24 weeks

DRUG

efalizumab plus acitretin

1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Giampiero Girolomoni · Universita di Verona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707070 on ClinicalTrials.gov