Psoriasis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg subcutaneous injections twice weekly for 12 weeks in subjects who have previously been treated etanercept and efficacy diminished.
Interventions
BIOLOGICALetanercept
50mgs subcutaneous injections twice a week for 12 weeks
Sponsors
Amgen
Florida Academic Dermatology Centers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with psoriasis who have previously been treated with etanercept for a minimum of 6 months and discontinued treatment due to loss of efficacy. Every attempt will be made to obtain loss of efficacy history from the subject's medical chart;when etanercept was commenced and terminated and description of patient's psoriasis on termination and details of new treatment commenced. Subjects must have failed their latest psoriasis treatment after a period of three months. This will be measured as a PGA of ≥ 3. * There is no specific requirement as to when prior treatment with etanercept occurred and no requirement as to what type of treatment(s) used between initial and subsequent treatments. * Are ≥ 18 years of age * PGA ≥ 3 * BSA minimum of 5% Tuberculosis inclusion 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. * Within 1 month prior to the first administration of study have a negative tuberculin skin test. * The ability to give written informed consent and comply with study procedures.
Exclusion criteria
* Current enrollment in any other investigational device or investigational drug trial(s), or receipt of any other investigational agent(s) within 28 days before baseline visit. * Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept. * Latex sensitivity \[NB: only applicable if they are using prefilled syringe or prefilled SureClick™ autoinjector presentations\] * Prior or concurrent use of cyclophosphamide therapy * Concurrent sulfasalazine therapy. * A positive HBV test or known history of any other immuno-suppressing disease. * Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis medication. * Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits. * History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection and Hepatitis C, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB, or other opportunistic infections * If etanercept was previously discontinued due to a serious adverse event * Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months of screening visit; unstable angina pectoris; uncontrolled hypertension (sitting systolic BP \<80 mm Hg or \> 160 or diastolic BP \> 100 mm Hg); oxygen-dependent severe pulmonary disease; history of cancer within 5 years \[other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer\]) * Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder. * Use of a live vaccine 90 days prior to screening visit, or concurrent use of a live vaccine. * Any condition or circumstances judged by the patient's physician \[or the investigator or medically qualified study staff\] to render this clinical trial detrimental or otherwise unsuitable for the patient's participation. * Female subjects who are pregnant, nursing or planning pregnancy (both men and women) and not using acceptable methods of birth control during the trial (hormonal, barriers, abstinence). * Women who are breast feeding History of non-compliance with other therapies. * History of alcohol abuse within the last 12 months * Concurrent use of anakinra * Subjects who cannot discontinue any of the drugs below for 2 weeks prior to the baseline visit or during the study; A two week wash out period is appropriate as it would be unethical to expect subjects whose disease if flaring to remain untreated for a longer period of time. The first dose of etanercept will be administered two weeks after the last biologic dose. * Immunosuppressants, antimalarials, or sulfasalazine. * Other Ani-TNFs * Cyclosporine * Efalizumab * Azathioprine * Hydroxyurea * Live vaccines * Tacrolimus * Oral retinoids (isotretinoin,acitretin,bexarotene) * Ultra violet light therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12. | 12 weeks | Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12 will measure efficacy of retreatment with etanercept |
Countries
United States
Outcome results
None listed