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Main
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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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13 December 2021 |
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Main ID: |
EUCTR2008-004439-39-FR |
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Date of registration:
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23/10/2009 |
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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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Randomized Open-label Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept Treatment
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Scientific title:
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Randomized Open-label Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept Treatment |
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Date of first enrolment:
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04/02/2010 |
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Target sample size:
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298 |
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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:2008-004439-39 |
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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: yes
Single blind:
Double blind:
Parallel group: yes
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Comparison btwn stop arm which is contrl grp & maintenance arm (low dose group).
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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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France
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Germany
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Greece
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Hungary
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Italy
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Portugal
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Spain
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United Kingdom
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Contacts
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Affiliation:
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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. Previously treated with ETN for chronic plaque psoriasis for at least 20 weeks
prior to the screening visit, who are documented to have been on a total weekly
dose of 50mg per week for at least the 6 weeks preceding the day of the
screening visit and who have shown clinical response with a PGA inferior or equal
to 1 at the screening visit
3. Having shown clinical response with a PGA inferior or equal to 1 at the screening
visit
4. With a PGA inferior or equal to 1 at the baseline visit
5. Where the last injection of ETN was performed not more than 7 days before the
baseline visit
6. Able to store the injectable investigational product under refrigerated conditions
7. Able to self-inject investigational product or have a designee who can do so
8. Able to complete health outcome assessments and any study diaries.
9. Demonstrates an adequate screening for tuberculosis (TB) in accordance with
local country guidelines, since ETN has been prescribed, tests results and/or
radiographic report must be available at site
10. Is a man or woman who is surgically sterile or is at least 1 year postmenopausal.
A woman not surgically sterile or at least 1 year postmenopausal must
demonstrate a negative serum pregnancy test at screening and a negative
urine pregnancy test at baseline, and must agree and commit to use medically
acceptable forms of contraception.
All female subjects who are also taking known teratogens, eg methotrexate, acitretin, must agree and commit to use contraceptive precautions as recommended by the respective SPCs, data sheets or equivalent legal documents. In addition, all male subjects taking concomitant methotrexate who are biologically capable of
having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of methotrexate.
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 (eg eczema) other than psoriasis that would interfere
with evaluations of the effect of study medication on psoriasis
2. Evidence of active or previously known medical history of inflammatory arthritis
3. Any biologics other than ETN within the 20 weeks prior to the screening visit
4. Ciclosporin, within 28 days of the baseline visit
5. Received isoniazid (INH) therapy during screening and has had the mandatory
liver function test (LFT) before the baseline visit that is out of the normal lab
range.
6. Receipt of any live (attenuated) vaccine within 4 weeks before baseline.
7. Sunbathing or UV treatment for therapeutic reasons (ultraviolet light A [UVA],
psoralen and ultraviolet light A therapy [PUVA], or ultraviolet light B [UVB] therapy,
including narrow band UVB and excimer laser) within 28 days of the baseline visit.
8. Oral, intravenous, intramuscular, intraarticular and subcutaneous (SC)
corticosteroids within 28 days of the baseline visit. Exception: inhaled
corticosteroids for the treatment of pulmonary conditions and topical ophthalmic
solutions containing corticosteroids with or without antibiotics for episodes of
acute ocular inflammation are permitted.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Plaque psoriasis
MedDRA version: 12.0
Level: LLT
Classification code 10037153
Term: Psoriasis
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Intervention(s)
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Trade Name: Enbrel 25mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Enbrel 50mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
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Primary Outcome(s)
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Main Objective: To describe the effect on subjects in whom psoriasis has responded to initial treatment with etanercept (ETN) of two different strategies for managing a good response or complete response (PGA= 1 or 0) over a 52 week period..
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Secondary Objective: • To compare the efficacy of the 2 different strategies by reference to quality of life measure over the duration of the study
• To explore the time course of severity following treatment modification
• To explore the degree of subject satisfaction with the two different options for management following successful initial treatment
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Primary end point(s): The primary efficacy endpoint is the average 52 week PGA (measured as the time-normalized area under curve)
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Secondary ID(s)
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0881X1-4535-WW
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2008-004439-39-GB
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 04/02/2010
Contact:
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