Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00581555
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : April 23, 2012
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE December 27, 2007
Results First Submitted Date  ICMJE November 17, 2010
Results First Posted Date  ICMJE April 23, 2012
Last Update Posted Date April 23, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Evaluation of change in PASI score from randomization to week 24 [ Time Frame: 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • PASI Area under the Curve between randomization and week 24 [ Time Frame: 24 weeks ]
  • Change in PGA score [ Time Frame: 24 weeks ]
  • % Relapse and time to relapse [ Time Frame: 24 ]
  • % Improvement in PASI score [ Time Frame: 24 weeks ]
  • Change in DLQI [ Time Frame: 24 weeks ]
  • Incidence of adverse events [ Time Frame: 24 weeks ]
  • Rebound effects (worsening of psoriasis) [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Monitor Wyeth 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