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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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23 December 2013 |
Main ID: |
EUCTR2008-004439-39-PT |
Date of registration:
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29/12/2009 |
Prospective Registration:
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Yes |
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 |
Date of first enrolment:
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09/04/2010 |
Target sample size:
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298 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004439-39 |
Study type:
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Interventional clinical trial of medicinal product |
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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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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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. . (Note: the liver function test profile blood samples must be drawn after initiating isoniazid therapy at a minimum of 3 weeks and at least 4 days prior to the planned baseline visit). 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. 9. Clinically relevant concurrent medical events including: - Known history or presence of hepatitis B or hepatitis C infection, including known presence of alcoholic hepatitis - History of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes - Diagnosis of multiple sclerosis or other central or peripheral nervous system demyelinating diseases - Presence or history of confirmed blood dyscrasias - Uncontrolled diabetes mellitus - Open cutaneous ulcers - Presence or history of cancer (or carcinoma in situ) other than resected cutaneous basal cell or squamous cell carcinoma within the past 5 years before the screening visit 10. History of anti-cardiolipin antibodies associated with a thrombotic event or recurrent fetal loss. 11. Receipt of any investigational or biologic drugs within 3 months prior to Screening Visit 12. Pregnant or breast-feeding women
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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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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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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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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2008-004439-39-GB
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0881X1-4535-WW
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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