Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

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NCT00663052

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Study Location
Pfizer Investigational Site
Capital Federal, Buenos Aires, 01114, Argentina
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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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.

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Plaque Psoriasis, PsoriasisStudy Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis
NCT00663052
  1. Capital Federal, Buenos Aires
  2. Capital Federal, Buenos Aires
  3. San Miguel, Buenos Aires
  4. Feldkirch,
  5. Wien,
  6. Bruxelles,
  7. Gent,
  8. Liege,
  9. Jihlava,
  10. Ostrava- Poruba,
  11. Plzen-Bory,
  12. Bochum,
  13. Erlangen,
  14. Frankfurt am Main,
  15. Hamburg,
  16. Kiel,
  17. Muenchen,
  18. Osnabrueck,
  19. Athens,
  20. Athens,
  21. Budapest,
  22. Debrecen,
  23. Miskolc,
  24. Szeged,
  25. Catanzaro,
  26. L'Aquila,
  27. Gangnam-gu,
  28. Seoul,
  29. Zapopan, Jalisco
  30. Monterrey, Nuevo Leon / Mexico
  31. Monterrey, Nuevo Leon
  32. Santiago de Compostela, La Coruña
  33. Fuenlabrada, Madrid
  34. Barcelona,
  35. Valencia,
  36. Taipei TOC,
  37. Taipei,
  38. Bangkok,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Plaque Psoriasis
  • Psoriasis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Group A
    A
    Intervention: Drug: Etanercept
  • Experimental: Group B
    B
    Intervention: Drug: Etanercept
Publications *

*   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: March 29, 2012)		273
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2008)		250
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 Argentina,   Austria,   Belgium,   Czech Republic,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Spain,   Taiwan,   Thailand
Removed Location Countries Brazil,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT00663052
Other Study ID Numbers  ICMJE 0881A6-4425
B1801013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2012

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