Back to resultsCombining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis (CobAcE)
Primary Purpose
Chronic Plaque Psoriasis
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
efalizumab plus placebo
efalizumab plus acitretin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring psoriasis, acitretin, efalizumab
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Univeristy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral
efalizumab 1 mg/Kg/week subcutaneous plus oral placebo
Outcomes
Primary Outcome Measures
PASI 75 and PASI 50 at week 24 Physician Global Assessment
Secondary Outcome Measures
SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00707070
Brief Title
Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis
Acronym
CobAcE
Official Title
Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Universita di Verona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
psoriasis, acitretin, efalizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
efalizumab 1 mg/Kg/week subcutaneous plus oral placebo
Intervention Type
Drug
Intervention Name(s)
efalizumab plus placebo
Intervention Description
1 mg/kg/week subcutaneous for 24 weeks
Intervention Type
Drug
Intervention Name(s)
efalizumab plus acitretin
Intervention Description
1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day
Primary Outcome Measure Information:
Title
PASI 75 and PASI 50 at week 24 Physician Global Assessment
Time Frame
week 12 and 24
Secondary Outcome Measure Information:
Title
SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giampiero Girolomoni, Prof
Phone
39-045-812-2547
Ext
0039
Email
giampiero.girolomoni@univr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giampiero Girolomoni
Organizational Affiliation
Universita di Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy Hospital
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Gisondi, MD
Phone
45-812-2547
Ext
0039
Email
paolo.gisondi@univr.it
First Name & Middle Initial & Last Name & Degree
Micol Del Giglio, MD
First Name & Middle Initial & Last Name & Degree
Paolo Gisondi, MD
First Name & Middle Initial & Last Name & Degree
Giampiero Girolomoni, Prof.
12. IPD Sharing Statement
Citations:
PubMed Identifier
18211428
Citation
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.
Results Reference
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Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis
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