Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

Layout table for study information
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier (NCT number): NCT00707070

Layout table for location contacts
Contact: Giampiero Girolomoni, Prof 39-045-812-2547 ext 0039

Layout table for location information
Univeristy Hospital
Verona, Italy, 37126
Contact: Paolo Gisondi, MD    45-812-2547 ext 0039   
Sub-Investigator: Micol Del Giglio, MD         
Sub-Investigator: Paolo Gisondi, MD         
Principal Investigator: Giampiero Girolomoni, Prof.         
Sponsors and Collaborators
Universita di Verona
Layout table for investigator information
Principal Investigator: Giampiero Girolomoni Universita di Verona
Layout table for additonal information
Responsible Party: Giampiero Girolomoni, University of Verona Identifier: NCT00707070    
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:
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents