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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Universita di Verona.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Universita di Verona
ClinicalTrials.gov Identifier:
NCT00707070
First received: June 26, 2008
Last updated: June 27, 2008
Last verified: June 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
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

  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
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, see Learn About Clinical Studies.

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 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
  More Information

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
Study First Received: June 26, 2008
Last Updated: June 27, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by Universita di Verona:
psoriasis
acitretin
efalizumab

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

ClinicalTrials.gov processed this record on July 22, 2014