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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Other: Placebo; Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00581555

0881A6-410

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

etanercept

Experimental group

Description:

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

Treatment:

Drug: Etanercept

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo