Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

NCT00581100

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nail Psoriasis, Plaque 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

- Active, stable plaque psoriasis defined by the following criteria:

- Body surface area (BSA) ≥ 10 % at screening and baseline

- Or, PASI >10 at screening and baseline

- Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline

- Or, DLQI > 10 at baseline

- Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI > 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator.

- Failure of at least one systemic psoriasis therapy for nail psoriasis

- Eligible to receive biologic therapy for psoriasis in accordance to local guidelines

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


- Evidence of Skin conditions other than psoriasis


- Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate,
acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug
initiation


- Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab

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Nail Psoriasis, Plaque PsoriasisEffects of Etanercept on Nail Psoriasis and Plaque Psoriasis NCT00581100
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
Official Title  ICMJE Randomised, Open-label Preliminary Study to Assess the Effects of 2 Regimens of Etanercept on Nail and Skin Symptoms in Patients With Nail Psoriasis and Plaque Psoriasis
Brief Summary The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.
Detailed Description This study will assess the effects of the 2 Etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. The endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth.
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
  • Nail Psoriasis
  • Plaque Psoriasis
Intervention  ICMJE Drug: etanercept

Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks.

Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period.

Study Arms  ICMJE
  • Active Comparator: 1
    etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24
    Intervention: Drug: etanercept
  • Active Comparator: 2
    etanercept 50 mg SC once weekly for the complete 24 week treatment period
    Intervention: Drug: etanercept
Publications * Not Provided

*   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: February 16, 2010)
136
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)
120
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older
  • Active, stable plaque psoriasis defined by the following criteria:

    • Body surface area (BSA) ? 10 % at screening and baseline
    • Or, PASI >10 at screening and baseline
    • Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline
    • Or, DLQI > 10 at baseline
  • Active fingernail psoriasis defined as target fingernail NAPSI ? 2 and overall NAPSI > 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator.
  • Failure of at least one systemic psoriasis therapy for nail psoriasis
  • Eligible to receive biologic therapy for psoriasis in accordance to local guidelines

Exclusion Criteria:

  • Evidence of Skin conditions other than psoriasis
  • Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation
  • Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
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  
 
Administrative Information
NCT Number  ICMJE NCT00581100
Other Study ID Numbers  ICMJE 0881A6-409
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

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