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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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etanercept

Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

Etanercept 50 mg QW initiated during taper of ciclosporin

placebo

Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Randomized to placebo during taper of ciclosporin

Interventions

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Etanercept

Etanercept 50 mg QW initiated during taper of ciclosporin

Intervention Type DRUG

Placebo

Randomized to placebo during taper of ciclosporin

Intervention Type OTHER

Other Intervention Names

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Enbrel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No