Status:
COMPLETED
Moderate to Severe Plaque Psoriasis With Scalp Involvement
Lead Sponsor:
Amgen
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if etanercept is effective in the treatment of scalp involvement in moderate to severe plaque psoriasis.
Eligibility Criteria
Inclusion
- Must provide written informed consent before any study-specific procedure
- Be male or female greater than or equal to 18 years of age at time of screening
- Has stable moderate to severe plaque psoriasis for at least 6 months
- Affected body surface area (BSA) greater than or equal to 10%
- Psoriasis Area and Severity Index (PASI) score greater than or equal to 10
- At least 30 percent affected scalp surface area
- Psoriasis Scalp Severity Index (PSSI) score greater than or equal to 15
- Candidate for systemic therapy or phototherapy in the opinion of the investigator
- Negative test for hepatitis B surface antigen, hepatitis C antibody, and Human Immunodeficiency Virus (HIV)
- Negative serum pregnancy test for female subjects (unless 3 years post menopausal or surgically sterile)
- Willing to use medically acceptable form of birth control for duration of study
- Negative Purified Protein Derivative (PPD) within 30 days prior to first dose of study drug
Exclusion
- Any active infection
- Significant concurrent medical conditions, including: Insulin dependent diabetes mellitus; Congestive heart failure; Myocardial infarction within last year; Unstable angina pectoris; Uncontrolled hypertension; Severe pulmonary disease \[requiring oxygen therapy or hospitalization\]; Systemic lupus erythematosus; Multiple sclerosis or any other demyelinating disease; Active malignancy
- Any condition, in opinion of study doctor, that might cause this study to be detrimental to subject
- History of cancer within 5 years before first dose of study drug
- Skin conditions other than psoriasis that would interfere with evaluations of the effect of study medications on psoriasis
- Presence of guttate, erythrodermic or pustular psoriasis
- Use of topical cyclosporine or calcineurin inhibitors within 14 days of first dose of study drug
- Use of tar shampoos within 14 days of first dose of study drug
- Use of following therapies within 28 days of first dose of study drug: IV or oral cyclosporine or calcineurin inhibitors, Ultraviolet Light A therapy, Psoralen plus ultraviolet A radiation, Oral retinoids, Ultraviolet Light B therapy, Topical steroids or steroid shampoo, Topical vitamin A or D analog preparations, Anthralin, other systemic psoriasis therapy, cyclophosphamide, sulfasalazine, anakinra
- Use of Alefacept (Amevive), Efalizumab (Raptiva), Anti-tumor necrosis factor (TNF) biologic therapies within 3 months of the first dose of study drug. Prior anti-TNF use will not be permitted if discontinued due to lack of efficacy, an adverse event, or non-compliance.
- Use of interleukin (IL)-12/IL-23 within 6 months of the first dose of study drug
- Participation in another clinical trial within 90 days or 5 half-lives (whichever is longer) of randomization
- Laboratory abnormalities at screening: hemoglobin less than 11 g/dL, platelet count less than 125,000/mm\^3, white blood cell count less than 3,500 cells/mm\^3, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than or equal to 1.5 x the upper limit of normal, any other laboratory abnormality which will prevent patient from completing the study or interfere with interpretation of study results
- Patient is pregnant or breast feeding
- Presence of any condition that could compromise the patient's ability to participate in the study, such as a history of substance abuse or psychiatric condition
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00791765
Start Date
October 1 2008
End Date
March 1 2010
Last Update
July 23 2014
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