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

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NCT00581555

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
Official Title  ICMJE A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy
Brief Summary The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Etanercept
    Etanercept 50 mg QW initiated during taper of ciclosporin
    Other Name: Enbrel
  • Other: Placebo
    Randomized to placebo during taper of ciclosporin
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2012)		120
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)		144
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (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 NCT00581555
Other Study ID Numbers  ICMJE 0881A6-410
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:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
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