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Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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

NCT00581100
Pfizer
Completed
Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

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Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Nail Psoriasis
  • Plaque Psoriasis
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.

  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
October 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00581100
0881A6-409
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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