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Completed

NCT Number: NCT00581555

Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping 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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

Etanercept 50 mg QW initiated during taper of ciclosporin

Other names: Enbrel

Placebo

Other

Randomized to placebo during taper of ciclosporin

Primary outcomes

  1. Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)

    Time frame: Randomization to Week 24.

    PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.

Secondary outcomes

  1. PASI Area Under the Curve (AUC) Between Randomization and Week 24

    Time frame: Randomization to Week 24.

    PASI AUC = Area under the curve from randomization (Week 6) to Week 24.

  2. Change From Randomization in PGA Score to Week 24

    Time frame: Randomization to Week 24.

    PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.

  3. Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization

    Time frame: Randomization to Week 24.

    Relapse was defined as the loss of 50% improvement in PASI.

  4. Probability of Being Relapse Free During the 24 Weeks After Randomization

    Time frame: Randomization to Week 24.

    Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.

  5. Percent (%) Change of PASI Score From Randomization to Week 24

    Time frame: Randomization to Week 24.

    Percent improvement in PASI score was calculated from Week 6 to Week 24.

  6. Change From Randomization in DLQI to Week 24

    Time frame: Randomization to Week 24.

    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).

  7. DLQI at Each Visit From Baseline

    Time frame: Baseline to Week 24.

    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).

  8. Percentage of Rebound Effects

    Time frame: Baseline to Week 24.

    Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 27, 2007
Registry last updated
Apr 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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