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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. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2006-004454-25-ES |
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Date of registration:
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24/01/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A multicenter double blind, placebo-controlled randomized pilot study evaluating efficacy and safety of ETN in patients with moderate to severe plaque psoriasis after cessation of ciclosporin therapy
"Estudio piloto aleatorizado, multicéntrico, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de ETN en pacientes con psoriasis en placas moderada o intensa tras la interrupción del tratamiento con ciclosporina"
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Scientific title:
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A multicenter double blind, placebo-controlled randomized pilot study evaluating efficacy and safety of ETN in patients with moderate to severe plaque psoriasis after cessation of ciclosporin therapy
"Estudio piloto aleatorizado, multicéntrico, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de ETN en pacientes con psoriasis en placas moderada o intensa tras la interrupción del tratamiento con ciclosporina"
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Date of first enrolment:
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24/04/2007 |
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Target sample size:
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136 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004454-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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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:
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Germany
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Greece
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Italy
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Malta
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Spain
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Age between 18 and 70 years;
BSA>10% or PASI>10;
Negative result of b-HCG;
Sexually active men and women participating in the study must use a medically acceptable form of contraception that needs to be continued for 3 months following discontinuation of ciclosporin;
Ability to inject study drug subcutaneously;
Ability to store injectable test article at 2°C to 8°C.
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:
Evidence of skin conditions (eg, eczema) other than psoriasis;
PUVA;
Ciclosporin, acitretin, alefacept; efalizumab, infliximab, anakinra or any DMARD within 90 days of screening;
UVB topical steroids, topical Vitamin A or D analog preparations, or anthralin within 14 days of screening;
Any TNF-inhibitor, including etanercept;
Serious infection;
Abnormal hematology or chemistry;
Receipt of any live (attenuated) vaccine within 4 weeks prior to randomization;
Pregnant or breast-feeding women;
Significant concurrent medical conditions at the time of screening.
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 chronic plaque psoriasis.
Psoriasis en placas moderada a intensa
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Intervention(s)
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Trade Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder and solvent for 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): Evaluation of change in PASI score from randomization to week 24 (week 18 of ETN monotherapy). PASI Area Under the Curve (AUC) between randomization and week 24; Change in PGA score; % Relapse; % improvement in PASI; Change in DLQI
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Main Objective: To demonstrate the sustained efficacy and safety of etancercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.
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Secondary Objective:
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Secondary ID(s)
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0881A6-410
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 13/03/2007
Contact:
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