A Randomised, Open-Label Preliminary Study To Assess The Effects Of Etanercept 50 mg Once Weekly For 24 Weeks And Etanercept 50 mg Twice Weekly For 12 weeks Reducing To Etanercept 50 mg Once Weekly For 12 weeks On Nail And Skin Symptoms In Patients With Nail Psoriasis And Plaque Psoriasis.
- Conditions
- ail psoriasis
- Registration Number
- EUCTR2006-004453-18-FR
- Lead Sponsor
- Wyeth Pharmaceuticals France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1.18 years of age or older at time of consent
2. Active, stable plaque psoriasis defined by the following criteria:
· Body surface area (BSA) >= 10 % at screening and baseline
· Or, PASI >10 at screening and baseline
· Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline
· Or, DLQI > 10 at baseline
3. Active fingernail psoriasis as defined as target fingernail NAPSI >= 2 and overall NAPSI > 14 – Target nail is defined as the nail with most severe overall grading at baseline.
4. Failure of at least one systemic psoriasis therapy for nail psoriasis
5. Eligible to receive biologic therapy for psoriasis in accordance to local guidelines
6. Able to store injectable test article between 2° and 8°C
7. Able and willing to self-inject test article or have a designee who can do so.
8. Women of childbearing potential must have a negative urine pregnancy test at screening. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
9. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article.
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
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. Psoralen plus ultraviolet A radiation (PUVA), cyclosporine, alefacept (Amevive™), efalizumab (Raptiva™), methotrexate, acitretin or any other systemic anti-psoriasis therapy within 3 months of study drug initiation.
3. Prior exposure to any TNF-inhibitor, including ETN
4. Severe comorbidities, including but not limited to; uncontrolled insulin dependent diabetes mellitus, uncompensated congestive heart failure (CHF), history of myocardial infarction (MI) within 12 months of screening visit, unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease requiring hospitalisation or supplemental oxygen, cancer or history of cancer within 5 years (other than resected cutaneous basal cell or squamous cell carcinoma), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive, systemic lupus erythematosus, history of multiple sclerosis or any other demyelinating disease.
5. Tuberculosis (TB) infection (Note: follow local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy)
6. Serious infection (infection associated with hospitalisation and/or intravenous antibiotics) within 1 month of test article administration or active infection at screening
7. Known history of human immunodeficiency virus (HIV) infection
8. Any condition that, in the investigator’s judgment, might cause this study to be detrimental to the subject
9. Receipt of any live (attenuated) vaccine within 28 days of screening visit
10. Known contraindication or hypersensitivity to etanercept or its excipients.
11. Pregnant or breast-feeding women.
12. Reasonable expectation that the subject will not be able to satisfactorily complete the study13. History of or current psychiatric illness that would interfere with the subject’s ability to comply with protocol requirements or give informed consent.
14. History of alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements.
15. Receipt of any investigational drugs within 28 days of screening visit.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method