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Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

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NCT00663052

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Capital Federal, Buenos Aires, 01114 Argentina
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Plaque Psoriasis, 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

- 18 years of age or older at time of consent.

- Active, moderate to severe chronic plaque psoriasis defined by the following criteria:
Clinically stable, plaque psoriasis involving greater than or equal to 10% body
surface area (BSA) or PASI greater than or equal to 10.

- In the opinion of the investigator, failure, intolerance, contraindication or not a
candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus
ultraviolet A radiation (PUVA) therapy.

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

- Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere
with evaluations of the effect of study medication on psoriasis.

- Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous,
systemic vasculitis, scleroderma and polymyositis, or associated syndromes.

- Active or recent (within 2 years) tuberculosis (TB) infection.

NCT00663052
Pfizer
Completed
Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

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Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis
A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis
The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Plaque Psoriasis
  • Psoriasis
  • Drug: Etanercept
    ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.
  • Drug: Etanercept
    ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.
  • Experimental: Group A
    A
    Intervention: Drug: Etanercept
  • Experimental: Group B
    B
    Intervention: Drug: Etanercept


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
273
January 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older at time of consent.
  • Active, moderate to severe chronic plaque psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (BSA) or PASI greater than or equal to 10.
  • In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus ultraviolet A radiation (PUVA) therapy.

Exclusion Criteria:

  • Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  • Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
  • Active or recent (within 2 years) tuberculosis (TB) infection.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Belgium,   Czech Republic,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Spain,   Taiwan,   Thailand
Brazil,   Netherlands
 
NCT00663052
0881A6-4425
B1801013
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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