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
  Purpose

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


Condition Intervention Phase
Psoriasis
Biological: Etanercept
Biological: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 124
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Etanercept
Etanercept for subcutaneous injection.
Other Name: Enbrel®
Biological: Placebo
Placebo for subcutaneous injection.
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.
Biological: Etanercept
Etanercept for subcutaneous injection.
Other Name: Enbrel®
Biological: Placebo
Placebo for subcutaneous injection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791765

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00791765     History of Changes
Other Study ID Numbers: 20080014
Study First Received: November 14, 2008
Results First Received: September 3, 2010
Last Updated: July 14, 2014
Health Authority: Canada: Institutional Review Board
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Amgen:
Scalp
Psoriasis
Plaque Psoriasis
Skin Diseases
Moderate to severe plaque psoriasis
etanercept

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014