Moderate to Severe Plaque Psoriasis With Scalp Involvement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00791765
First received: November 14, 2008
Last updated: July 14, 2014
Last verified: July 2014

November 14, 2008
July 14, 2014
October 2008
January 2010   (final data collection date for primary outcome measure)
Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.
Percent change in the Psoriasis Scalp Severity Index [PSSI] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00791765 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With PSSI 75% Response at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.
  • Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.
  • Patient Satisfaction With Treatment at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from "very dissatisfied" to "very satisfied") to indicate his or her level of satisfaction with the medication's control of psoriasis.
  • Proportion of subjects achieving at least a 75% response by PSSI [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percent change in PSSI from week 12 in subjects switching from placebo to etanercept at week 12 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction with treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Evaluation of the safety of etanercept in the studied population [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Moderate to Severe Plaque Psoriasis With Scalp Involvement
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Treating Scalp Involvement in Subjects With Moderate to Severe Plaque Psoriasis

The purpose of this study is to determine if etanercept is effective in the treatment of scalp involvement in moderate to severe plaque psoriasis.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Biological: Etanercept
    Etanercept for subcutaneous injection.
    Other Name: Enbrel®
  • Biological: Placebo
    Placebo for subcutaneous injection.
  • Experimental: 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.
    Interventions:
    • Biological: Etanercept
    • Biological: Placebo
  • Experimental: 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.
    Interventions:
    • Biological: Etanercept
    • Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
March 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00791765
20080014
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP