Randomized Open-label Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept Treatment - ReSPONSE

• Register: EUCTR
• Last refreshed on: 15 July 2013
• Main ID: EUCTR2008-004439-39-IT
• Date of registration: 19/02/2010
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development
• Public title: Randomized Open-label Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept Treatment - ReSPONSE
• Scientific title: Randomized Open-label Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept Treatment - ReSPONSE
• Date of first enrolment: 04/08/2010
• Target sample size: 298
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004439-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Confronto tra il braccio d`interruzione e manten.

Countries of recruitment

France, Germany, Greece, Hungary, Italy, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
- Eighteen (18) years of age or older at time of consent. - Previously treated with ETN for chronic plaque PSO for at least 20 weeks prior to the screening visit, who are documented to have been on a total weekly dose of 50 mg per week for at least the 6 weeks preceding the day of the screening visit - Having shown clinical response with a PGA 1 at the screening visit. - With a PGA 1 at the baseline visit. - Where the last injection of ETN was performed not more than 7 days before the baseline visit. - Able to store the injectable investigational product under refrigerated conditions. - Able to self-inject investigational product or have a designee who can do so. - Able to complete health outcome assessments and any study diaries. - 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. - 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:
- Evidence of skin conditions (eg, eczema) other than PSO that would interfere with evaluations of the effect of study medication on PSO. - Evidence of active or previously known medical history of inflammatory arthritis. - Any biologics other than ETN within the 20 weeks prior to the screening visit. - Ciclosporin, within 28 days of the baseline visit. - Received isoniazid (INH) therapy during screening and has had the mandatory liver function test (LFT) profile 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). - Receipt of any live (attenuated) vaccine within 4 weeks before baseline. - 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. - Oral, intravenous, intramuscular, intra-articular, 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. - Abnormal hematology or blood chemistry profile: - hemoglobin ≤85 g/L; - hematocrit ≤27%; - platelet count ≤125 x 109/L; - white blood cell count ≤3.5 x 109/L; - serum creatinine (Creat) ≥175 μmol/L; - aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥2 times the laboratory s upper limit of normal (ULN). - Clinically relevant concurrent medical events including: - Serious infection (infection associated with hospitalization and/or intravenous antibiotics) within 1 month before investigational product administration or active infection at screening, including known human immunodeficiency virus (HIV) infection. - Active or recent (within 2 years) TB infection (Note: local country guidelines should be followed for appropriate screening and prophylaxis in the setting of anti-tumor necrosis factor (TNF) therapy including a minimum of a chest radiograph and /or objective TB testing, such as purified protein derivative (PPD) or Quantiferon depending on what is acceptable per local guidelines). Subjects with latent TB infection may be allowed only if local guidelines are followed for prophylactic therapy and if treatment is initiated before therapy, followed by proof that no adverse drug reaction has occurred with the anti-TB medications. - Uncontrolled hypertension (defined as screening systolic blood pressure >160 mm Hg or screening diastolic blood pressure >100 mm Hg). - Myocardial infarction within 12 months of the screening visit. - Unstable angina pectoris within 6 months of the screening visit. - Class III or IV congestive heart failure as defined by the New York Heart Association [see Attachment 1]. - Severe pulmonary disease requiring hospitalization or supplemental oxygen within 12 months of screening. - Known history or presence of hepatitis B or hepatitis C infection, including known presence of alcoholic hepatitis - History of human immunodeficiency virus (HIV) infection, imm

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Plaque psoriasis.
MedDRA version: 12.1 Level: LLT Classification code 10037153 Term: Psoriasis

Intervention(s)

Trade Name: ENBREL*SC 4SIR 25MG 0,5ML+8TAM
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: ENBREL*SC 4SIR 50MG 1ML+8TAMP
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: - To compare the efficacy of the 2 different strategies by reference to quality of life (QoL) 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 2 different options for management following successful initial treatment.

Main Objective: To describe the effect on subjects in whom PSO has responded to initial treatment with ETN of 2 different strategies for managing a good response or complete response (PGA = 1or 0) over a 52-week time period.

Primary end point(s): Average 52-week PGA (measured as the time-normalized area under curve).

Secondary ID(s)

2008-004439-39-GB

0881X1-4535-WW