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Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis (CobAcE)

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ClinicalTrials.gov Identifier: NCT00707070
Recruitment Status : Unknown
Verified June 2008 by Universita di Verona.
Recruitment status was:  Not yet recruiting
First Posted : June 30, 2008
Last Update Posted : June 30, 2008
Sponsor:
Information provided by:
Universita di Verona

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.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: efalizumab plus placebo Drug: efalizumab plus acitretin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis
Study Start Date : September 2008
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Acitretin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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
Placebo Comparator: 2
efalizumab 1 mg/Kg/week subcutaneous plus oral placebo
Drug: efalizumab plus placebo
1 mg/kg/week subcutaneous for 24 weeks



Primary Outcome Measures :
  1. PASI 75 and PASI 50 at week 24 Physician Global Assessment [ Time Frame: week 12 and 24 ]

Secondary Outcome Measures :
  1. SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24 [ Time Frame: week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707070


Contacts
Contact: Giampiero Girolomoni, Prof 39-045-812-2547 ext 0039 giampiero.girolomoni@univr.it

Locations
Italy
Univeristy Hospital Not yet recruiting
Verona, Italy, 37126
Contact: Paolo Gisondi, MD    45-812-2547 ext 0039    paolo.gisondi@univr.it   
Sub-Investigator: Micol Del Giglio, MD         
Sub-Investigator: Paolo Gisondi, MD         
Principal Investigator: Giampiero Girolomoni, Prof.         
Sponsors and Collaborators
Universita di Verona
Investigators
Principal Investigator: Giampiero Girolomoni Universita di Verona

Publications:
Responsible Party: Giampiero Girolomoni, University of Verona
ClinicalTrials.gov Identifier: NCT00707070     History of Changes
Other Study ID Numbers: Gisondi 2
No grants were received
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: June 30, 2008
Last Verified: June 2008

Keywords provided by Universita di Verona:
psoriasis
acitretin
efalizumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Acitretin
Immunologic Factors
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents