Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis
CobAcE
Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis
2 other identifiers
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2008
CompletedFirst Posted
Study publicly available on registry
June 30, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJune 30, 2008
June 1, 2008
1.1 years
June 26, 2008
June 27, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PASI 75 and PASI 50 at week 24 Physician Global Assessment
week 12 and 24
Secondary Outcomes (1)
SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24
week 24
Study Arms (2)
1
EXPERIMENTALefalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral
2
PLACEBO COMPARATORefalizumab 1 mg/Kg/week subcutaneous plus oral placebo
Interventions
Eligibility Criteria
You may qualify if:
- Men aged 18-70
- Women in postmenopausal
- Moderate to severe chronic plaque psoriasis in patients with contraindication, intolerance or non responsive to cyclosporine, methotrexate or PUVA
- PASI \> 10 e/o BSA (Body Surface Area) \> 10
You may not qualify if:
- Drug induced psoriasis
- Pustular or erythrodermic psoriasis
- Fertile women
- Pregnancy or lactation
- cholesterol \> 230mg/dL e triglyceride \> 200 mg/dL
- Known intolerance to efalizumab and acitretin
- Serious infection at enrollement
- History of previous neoplasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univeristy Hospital
Verona, 37126, Italy
Related Publications (1)
Gisondi P, Girolomoni G. Combination of efalizumab and acitretin in chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2008 Feb;22(2):247-8. doi: 10.1111/j.1468-3083.2007.02303.x. No abstract available.
PMID: 18211428BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giampiero Girolomoni
Universita di Verona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 26, 2008
First Posted
June 30, 2008
Study Start
September 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
June 30, 2008
Record last verified: 2008-06