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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014