Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

NCT00936065

Last updated date
Study Location
Pfizer Investigational Site
Daejeon, Korea, 301 721, Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Moderate to Severe 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

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

- Negative urine pregnancy test before the first dose of study drug in all female patients

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.


- Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout,
systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or
associated syndromes.


- Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab
(Raptiva®) and alefacept (Amevive®) is also prohibited.

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Moderate to Severe PsoriasisStudy Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis
NCT00936065
  1. Daejeon, Korea
  2. Gyeonggido, Korea
  3. Seoul, Korea
  4. Seoul, Korea
  5. Seoul, Korea
  6. Seoul, Korea
  7. S0, Seoul
  8. Seoul,
  9. Seoul,
  10. Seoul,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis
Official Title  ICMJE A Multicenter, Randomized, Open Pilot Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly Followed Etanercept 25mg Twice Weekly, the Combination of Etanercept 25 mg Twice Weekly and Acitretin and Acitretin Alone in Patients With Moderate to Severe Psoriasis
Brief Summary To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Psoriasis
Intervention  ICMJE
  • Drug: Etanercept
    Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks
    Other Name: Etanercept 50mg followed by 25mg
  • Drug: Etanercept + Acitretin
    Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks
    Other Name: Etancercept 25mg and Acitretin 10mg
  • Drug: Acitretin
    Acitretin at a dose of 10mg BID for 24 weeks
    Other Name: Acitretin 10mg
Study Arms  ICMJE
  • Active Comparator: Group A
    Intervention: Drug: Etanercept
  • Experimental: Group B
    Intervention: Drug: Etanercept + Acitretin
  • Active Comparator: Group C
    Intervention: Drug: Acitretin
Publications * Lee JH, Youn JI, Kim TY, Choi JH, Park CJ, Choe YB, Song HJ, Kim NI, Kim KJ, Lee JH, Yoo HJ. A multicenter, randomized, open-label pilot trial assessing the efficacy and safety of etanercept 50 mg twice weekly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone in patients with moderate to severe psoriasis. BMC Dermatol. 2016 Jul 25;16(1):11. doi: 10.1186/s12895-016-0048-z.

*   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: July 7, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 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.
  • Negative urine pregnancy test before the first dose of study drug in all female patients

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.
  • Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
  • Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.
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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00936065
Other Study ID Numbers  ICMJE 0881A6-4625
B1801065
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