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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581555
• Other study ID #: 0881A6-410
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2007
• Last updated: March 28, 2012
• Start date: October 2007
• Est. completion date: November 2009

Study information

• Verified date: March 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Etanercept
Etanercept 50 mg QW initiated during taper of ciclosporin

Other:
• Placebo
Randomized to placebo during taper of ciclosporin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)	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.	Randomization to Week 24.	No
Secondary	PASI Area Under the Curve (AUC) Between Randomization and Week 24	PASI AUC = Area under the curve from randomization (Week 6) to Week 24.	Randomization to Week 24.	No
Secondary	Change From Randomization in PGA Score 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.	Randomization to Week 24.	No
Secondary	Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization	Relapse was defined as the loss of 50% improvement in PASI.	Randomization to Week 24.	No
Secondary	Probability of Being Relapse Free During the 24 Weeks After Randomization	Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.	Randomization to Week 24.	No
Secondary	Percent (%) Change of PASI Score From Randomization to Week 24	Percent improvement in PASI score was calculated from Week 6 to Week 24.	Randomization to Week 24.	No
Secondary	Change From Randomization in DLQI 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).	Randomization to Week 24.	No
Secondary	DLQI at Each Visit From Baseline	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).	Baseline to Week 24.	No
Secondary	Percentage of Rebound Effects	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.	Baseline to Week 24.	Yes