Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

NCT01235442

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject has had stable moderate to severe plaque psoriasis for at least 6 months

- Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline.

- Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the
screening visit.


- Subject has evidence of skin conditions at the time of the screening visit (eg,
eczema) that would interfere with evaluations of the effect of etanercept
and/orclobetasol propionate foam on psoriasis.


- Subject diagnosed with medication-induced or medication exacerbated psoriasis


- Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection


- Subject has a significant concurrent medical condition or laboratory abnormalities as
defined in the study protocol.


- Subject has used any of the following therapies within 14 days of the first dose: UVB
therapy or topical psoriasis therapies other than Class I or II topical steroids.


- Subject has used any of the following therapies within 28 days of the first dose:
Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic
psoriasis therapies


- Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23
inhibitors) within 3 months of the first dose


- Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of
etanercept


- Subject has ever used efalizumab (Raptiva®).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
Official Title  ICMJE A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary The primary hypothesis of this trial is that the addition of short courses of clobetasol propionate foam to etanercept monotherapy in subjects with moderate to severe plaque psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: 1=Etanercept
    50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.
  • Drug: 2=Clobetasol propionate foam
    0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses
Study Arms  ICMJE
  • Experimental: etanercept and clobetasol
    Etanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24)
    Intervention: Drug: 2=Clobetasol propionate foam
  • Experimental: etanercept
    Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks
    Intervention: Drug: 1=Etanercept
Publications * Lebwohl MG, Kircik L, Callis Duffin K, Pariser D, Hooper M, Wenkert D, Thompson EH, Yang J, Kricorian G, Koo J. A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2013 Sep;69(3):385-92. doi: 10.1016/j.jaad.2013.03.031. Epub 2013 May 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2011)
592
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2010)
560
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has had stable moderate to severe plaque psoriasis for at least 6 months
  • Subject has involved BSA ? 10% and PASI ? 10 at screening and at baseline.
  • Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator

Exclusion Criteria:

  • Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
  • Subject has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept and/orclobetasol propionate foam on psoriasis.
  • Subject diagnosed with medication-induced or medication exacerbated psoriasis
  • Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection
  • Subject has a significant concurrent medical condition or laboratory abnormalities as defined in the study protocol.
  • Subject has used any of the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids.
  • Subject has used any of the following therapies within 28 days of the first dose: Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic psoriasis therapies
  • Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23 inhibitors) within 3 months of the first dose
  • Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of etanercept
  • Subject has ever used efalizumab (Raptiva®).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT01235442
Other Study ID Numbers  ICMJE 20080470
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:MDAmgen
PRS Account Amgen
Verification Date August 2015

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