Combining Acitretin and Efalizumab in the Therapy of Chro... | NCT00707070

Studies
Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis

NCT00707070

Sponsor

Universita di Verona

Status

Unknown status

Last Update Posted

Jun 30, 2008Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Chronic Plaque Psoriasis

Interventions

efalizumab plus placebo
efalizumab plus acitretin

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
No grants were received

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Oct 2009Estimated

Completion Date

Oct 2009Estimated

First Submitted Date

Jun 26, 2008

First Submission Date that Met QC Criteria

Jun 27, 2008

First Posted Date

Jun 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2008

Last Update Posted Date

Jun 30, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral	Drug: efalizumab plus acitretin
2	Placebo Comparator	efalizumab 1 mg/Kg/week subcutaneous plus oral placebo	Drug: efalizumab plus placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
efalizumab plus placebo	Drug	1 mg/kg/week subcutaneous for 24 weeks	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PASI 75 and PASI 50 at week 24 Physician Global Assessment		week 12 and 24

Secondary Outcomes

Measure	Description	Time Frame
SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24		week 24

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giampiero Girolomoni, Prof	Contact	39-045-812-2547	0039	giampiero.girolomoni@univr.it

Overall Officials

Name	Affiliation	Role
Giampiero Girolomoni	Universita di Verona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy Hospital		Verona		37126	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18211428	Background	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. No abstract available.

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839