Clinical trial NCT00581555: Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)
timeFrame: Randomization to Week 24.
Secondary outcomes:
measure: PASI Area Under the Curve (AUC) Between Randomization and Week 24
timeFrame: Randomization to Week 24.
measure: Change From Randomization in PGA Score to Week 24
timeFrame: Randomization to Week 24.
measure: Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization
timeFrame: Randomization to Week 24.
measure: Probability of Being Relapse Free During the 24 Weeks After Randomization
timeFrame: Randomization to Week 24.
measure: Percent (%) Change of PASI Score From Randomization to Week 24
timeFrame: Randomization to Week 24.
measure: Change From Randomization in DLQI to Week 24
timeFrame: Randomization to Week 24.
measure: DLQI at Each Visit From Baseline
timeFrame: Baseline to Week 24.
measure: Percentage of Rebound Effects
timeFrame: Baseline to Week 24.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.