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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

Tracking Information
First Submitted Date  ICMJE June 26, 2008
First Posted Date  ICMJE June 30, 2008
Last Update Posted Date June 30, 2008
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2008)
PASI 75 and PASI 50 at week 24 Physician Global Assessment [ Time Frame: week 12 and 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2008)
SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24 [ Time Frame: week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis
Official Title  ICMJE Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Plaque Psoriasis
Intervention  ICMJE
  • Drug: efalizumab plus placebo
    1 mg/kg/week subcutaneous for 24 weeks
  • Drug: efalizumab plus acitretin
    1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day
Study Arms  ICMJE
  • Experimental: 1
    efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral
    Intervention: Drug: efalizumab plus acitretin
  • Placebo Comparator: 2
    efalizumab 1 mg/Kg/week subcutaneous plus oral placebo
    Intervention: Drug: efalizumab plus placebo
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. doi: 10.1111/j.1468-3083.2007.02303.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 27, 2008)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2009
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00707070
Other Study ID Numbers  ICMJE Gisondi 2
No grants were received
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Giampiero Girolomoni, University of Verona
Study Sponsor  ICMJE Universita di Verona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giampiero Girolomoni Universita di Verona
PRS Account Universita di Verona
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP