Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis - Full Text View

Sponsor:	Universita di Verona
Information provided by:	Universita di Verona
ClinicalTrials.gov Identifier:	NCT00707070

Purpose

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Psoriasis

Drug Information available for: Acitretin Efalizumab

U.S. FDA Resources

Further study details as provided by Universita di Verona:

Primary Outcome Measures:

PASI 75 and PASI 50 at week 24 Physician Global Assessment [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24 [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]

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	Drug: efalizumab plus acitretin 1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day
2: Placebo Comparator efalizumab 1 mg/Kg/week subcutaneous plus oral placebo	Drug: efalizumab plus placebo 1 mg/kg/week subcutaneous for 24 weeks

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707070

Contacts

Contact: Giampiero Girolomoni, Prof

39-045-812-2547 ext 0039

giampiero.girolomoni@univr.it

Locations

Italy
Univeristy Hospital
Verona, Italy, 37126

Sponsors and Collaborators

Universita di Verona

Investigators

Principal Investigator:	Giampiero Girolomoni	University of Verona
Principal Investigator:	Giampiero Girolomoni	University of Verona

More Information

Publications:

Gisondi P, Girolomoni G. Combination of efalizumab and acitretin in chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2008 Feb;22(2):247-8. No abstract available.

Responsible Party:	University of Verona ( Giampiero Girolomoni )
Study ID Numbers:	Gisondi 2, No grants were received
Study First Received:	June 26, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00707070 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Universita di Verona:

psoriasis
acitretin
efalizumab

Additional relevant MeSH terms:

Keratolytic Agents
Skin Diseases
Psoriasis
Therapeutic Uses

Dermatologic Agents
Acitretin
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009