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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00581555
First received: December 21, 2007
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.


Condition Intervention Phase
Psoriasis
Drug: Etanercept
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo) [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • PASI Area Under the Curve (AUC) Between Randomization and Week 24 [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
    PASI AUC = Area under the curve from randomization (Week 6) to Week 24.

  • Change From Randomization in PGA Score to Week 24 [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
    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.

  • Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
    Relapse was defined as the loss of 50% improvement in PASI.

  • Probability of Being Relapse Free During the 24 Weeks After Randomization [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
    Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.

  • Percent (%) Change of PASI Score From Randomization to Week 24 [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
    Percent improvement in PASI score was calculated from Week 6 to Week 24.

  • Change From Randomization in DLQI to Week 24 [ Time Frame: Randomization to Week 24. ] [ Designated as safety issue: No ]
    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).

  • DLQI at Each Visit From Baseline [ Time Frame: Baseline to Week 24. ] [ Designated as safety issue: No ]
    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).

  • Percentage of Rebound Effects [ Time Frame: Baseline to Week 24. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 120
Study Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: etanercept
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Drug: Etanercept
Etanercept 50 mg QW initiated during taper of ciclosporin
Other Name: Enbrel
Placebo Comparator: placebo
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Other: Placebo
Randomized to placebo during taper of ciclosporin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581555

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00581555     History of Changes
Other Study ID Numbers: 0881A6-410
Study First Received: December 21, 2007
Results First Received: November 17, 2010
Last Updated: March 28, 2012
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by Pfizer:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cyclosporins
Cyclosporine
TNFR-Fc fusion protein
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014