Moderate to Severe Plaque Psoriasis With Scalp Involvement

NCT ID: NCT00791765

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-03-31

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo BIW/Etanercept 50 mg BIW

Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.

Group Type: EXPERIMENTAL

Etanercept

Intervention Type: BIOLOGICAL

Etanercept for subcutaneous injection.

Placebo

Intervention Type: BIOLOGICAL

Placebo for subcutaneous injection.

Etanercept 50 mg BIW/Etanercept 50 mg QW

Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.

Group Type: EXPERIMENTAL

Etanercept

Intervention Type: BIOLOGICAL

Etanercept for subcutaneous injection.

Placebo

Intervention Type: BIOLOGICAL

Placebo for subcutaneous injection.

Interventions

Etanercept

Etanercept for subcutaneous injection.

Intervention Type: BIOLOGICAL

Placebo

Placebo for subcutaneous injection.

Intervention Type: BIOLOGICAL

Other Intervention Names

Enbrel®

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Bagel J, Lynde C, Tyring S, Kricorian G, Shi Y, Klekotka P. Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept. J Am Acad Dermatol. 2012 Jul;67(1):86-92. doi: 10.1016/j.jaad.2011.07.034. Epub 2011 Oct 20.

Reference Type: BACKGROUND

PMID: 22014541 (View on PubMed)

Tyring S, Bagel J, Lynde C, Klekotka P, Thompson EH, Gandra SR, Shi Y, Kricorian G. Patient-reported outcomes in moderate-to-severe plaque psoriasis with scalp involvement: results from a randomized, double-blind, placebo-controlled study of etanercept. J Eur Acad Dermatol Venereol. 2013 Jan;27(1):125-8. doi: 10.1111/j.1468-3083.2011.04394.x. Epub 2011 Dec 21. No abstract available.

Reference Type: BACKGROUND

PMID: 22188302 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20080014

Identifier Type: -

Identifier Source: org_study_id