Psoriasis vulgaris
Conditions
Interventions
Trade Name: Enbrel
Product Name: Etanercept
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration number: 50-
Sponsors
Technical University of Dresden, faculty of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be =18 to 70 years of age at the screening, of either sex and of caucasian race. 2. Subjects must have had a diagnosis of moderate to severe plaque-type psoriasis for at least 2 months prior to study screening. 3. Subjects must have plaque-type psoriasis covering 10% of total body surface area and a PASI score of 12 or greater at baseline. 4. Subjects must be candidates for systemic treatment of psoriasis and have had systemic therapies such as ciclosprin, MTX and PUVA which did not result in sufficient improvement. 5. Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study. 6. Subjects are considered to be eligible according to the following tuberculosis (TB) screening criteria: - have no history of latent or active TB prior to screening; - have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; - have had no recent close contact with a person with active TB or, if there has been such contact, will referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication; - within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) or have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin test) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication; 7. Subjects must have a chest x-ray (posterior-anterior and lateral) within 3 months prior to to screening with no evidence of malignancy, infection, fibrosis, or current or old active TB. 8. The following laboratory tests (CBC, blood chemistry and urine analysis) must be in the normal parameters of the clinical laboratory of the University hospital of Dresden: haemoglobin, white blood cells, neutrophils, platelets, serum creatinine, aspartate aminotransferase, alanine aminotransferase, alkaline phophatase and gamma-glutamyltransferase. 9. Subjects must be free of any clinically significant disease other than psoriasis or psoriatic arthritis that would interfere with the study evaluations. 10. Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules. 11. Female subjects of childbearing potential and all men bust be using adequate birth control measures (eg abstinence, oral contraceptives, intrauterine device, barrier method with spermicide or surgical sterilization) and must continue using such measures until 6 months after receiving the last dose of study medication. 12. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at screening and negative urine pregnancy test at baseline. 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
Exclusion criteria: 1. Subjects who have non-plaque forms of psoriasis (eg erythrodermic, guttata or pustular). 2. Subjects who have current drug induced psoriasis 3. Female subjects who are pregnant, nursing, and both men and women who are planning pregnancy during the study period or during the 6 months after receiving of the last dose of study medication. 4. Subjects who are currently taking or have taken the following drugs within the specified time frame prior to baseline: - any therapeutic agent targeted at reducing TNF within 3 months. - any biologic within 3 months. - any live virus or bacterial vaccinations received within 3 months. - any systemic medications/treatments that could affect psoriasis or PASI evaluation within 3 months (2 years for leflunomide, unless being washed out with cholestyramine) - any systemic immunosuppressants within 4 weeks. - lithium within 4 weeks. - any topical medications/treatments that could effect PASI evaluations within 2 weeks. 5. Subjects who have a history of chronic congestive heart failure, chronic or recurrent infections. 6. Subjects who have or have had opportunistic infection (eg cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, mycobacteria other than TB) within 6 month prior to screening. 7. Subjects who have or have had Herpes zoster infection within 2 month prior to screening. 8. Subjects who are known to be infected with HIV, hepatitis B or hepatitis C. 9. Subjects who have a history of any clinically significant adverse events (including allergic reactions) to chimeric proteins or human recombinant products. 10. Subjects who have current signs or symptoms of severe , progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, systemic lupus erythematodes, lymphoproliferative disease. 11. Subjects who have a history of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis. 12. Subjects who have a transplanted organ. 13. Subjects who have any known malignancy or a history of malignancy within the previous 5 years (except of basal cell carcinoma of the skin that has been treated with no evidence of recurrence). 14. Subjects who are known to have had substance abuse (drug or alcohol) problem within the previous 3 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the influence of etanercept therapy in adult subjects diagnosed with moderate to severe plaque-type psoriasis on the proinflammatory function of TNFalpha and IL-12/23 secreting myeloid slan dendritic cells in psoriatic skin and blood.;Secondary Objective: The secondary objective of this study is to define slan dendritic cells (DC) as a new and attractive target for the treatment of psoriasis by elucidating their functional impact on the pathogenesis of psoriasis.;Primary end point(s): The primary endpoint for the study is the PASI75 response rate at week 24 (PASI is defined as the proportion of subjects achieving a=75% improvement in PASI from baseline to week 24). | — |
Countries
Germany
Outcome results
None listed