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Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy

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NCT00581555

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Between age 18 and 70 years

- Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.

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 psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept,
anakinra, or any other systemic anti-psoriasis therapy or disease-modifying
antirheumatic drugs (DMARD) with 28 days of screening

- ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog
preparations, or anthralin

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

- Corticosteroid dose of prednisone >10 mg/day

- Serious infection

- Receipt of any live vaccine

- Abnormal hematology or chemistry

- Body mass index (BMI) > 38

- Pregnancy or Breastfeeding

- Significant concurrent medical conditions

NCT00581555
Pfizer
Completed
Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy

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Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy
The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.
The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Psoriasis
  • Drug: Etanercept
    Etanercept 50 mg QW initiated during taper of ciclosporin
    Other Name: Enbrel
  • Other: Placebo
    Randomized to placebo during taper of ciclosporin
  • Experimental: etanercept
    Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
    Intervention: Drug: Etanercept
  • Placebo Comparator: placebo
    Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
    Intervention: Other: Placebo
Micali G, Wilsmann-Theis D, Mallbris L, Gallo G, Marino V, Brault Y, Germain JM. Etanercept reduces symptoms and severity of psoriasis after cessation of cyclosporine therapy: results of the SCORE study. Acta Derm Venereol. 2015 Jan;95(1):57-61. doi: 10.2340/00015555-1845.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2009
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Between age 18 and 70 years
  • Active and stable plaque psoriasis with a BSA?10 or PASI?10.

Exclusion Criteria:

  • Evidence of skin conditions other than psoriasis
  • Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or disease-modifying antirheumatic drugs (DMARD) with 28 days of screening
  • ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin
  • Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
  • Corticosteroid dose of prednisone >10 mg/day
  • Serious infection
  • Receipt of any live vaccine
  • Abnormal hematology or chemistry
  • Body mass index (BMI) > 38
  • Pregnancy or Breastfeeding
  • Significant concurrent medical conditions
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00581555
0881A6-410
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

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

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