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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2007-001724-12-IT |
Date of registration:
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24/10/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis - ND
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Scientific title:
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A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis - ND |
Date of first enrolment:
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06/11/2008 |
Target sample size:
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250 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001724-12 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Periodo 1 in doppio cieco; Periodo 2 in aperto
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Czech Republic
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Germany
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Greece
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Italy
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 18 years of age or older at time of consent. 2. Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving 10% body surface area (BSA) or PASI 10. 3. In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. 2. Any rheumatologic disease such as rheumatoid arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes. 3. All biologics such as Anakinra (Kineret), infliximab (Remicade), adalimumab (Humira), etanercept (Enbrel), abatacept (Orencia), or rituximab (Rituxan) within 12 weeks of the baseline visit and through the end of the study (week 24).
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Moderate to severe plaque psoriasis MedDRA version: 9.1
Level: LLT
Classification code 10050577
Term: Psoriatic plaque
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Intervention(s)
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Pharmaceutical Form: Solution for injection INN or Proposed INN: Etanercept Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Primary end point(s): Primary efficacy endpoint: Proportion of subjects achieving a 75% improvement from baseline in PASI score at week 24 when used with adjunctive topical therapy as needed.
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Main Objective: To evaluate the effect of etanercept 50 mg once weekly for 24 weeks and etanercept 50 mg twice weekly for 12 weeks followed by etanercept 50 mg once weekly for 12 weeks in treating the skin manifestations of psoriasis in subjects with moderate to severe psoriasis when used with adjunctive topical therapy as needed.The primary hypothesis is that etanercept 50 mg once weekly will provide a Psoriasis Area and Severity Index (PASI) 75 response (75% improvement from baseline in PASI) of at least 50% at week 24 when used with adjunctive topical therapy as needed. The conditional primary hypothesis is that etanercept 50 mg twice weekly followed by etanercept 50 mg once weekly will provide a PASI 75 response of at least 60% at week 24 when used with adjunctive topical therapy as needed.
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Secondary Objective: 1. To assess the impact of 2 different treatment regimens of etanercept on quality of life and pharmacoeconomic outcomes through 24 weeks in subjects with moderate to severe psoriasis. 2. To assess the cardiovascular risk profile for subjects with moderate to severe psoriasis. 3. To assess the safety of the 2 different treatment regimens of etanercept through 24 weeks in subjects with moderate to severe psoriasis.
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Secondary ID(s)
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2007-001724-12-ES
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0881A6-4425
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Source(s) of Monetary Support
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Results
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Results available:
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