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

NCT00581555 | Completed Phase 4 Results

• 1 other identifier: 0881A6-410
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (8)

• PASI Area Under the Curve (AUC) Between Randomization and Week 24

  Randomization to Week 24.

• Change From Randomization in PGA Score to Week 24

  Randomization to Week 24.

• Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization

  Randomization to Week 24.

• Probability of Being Relapse Free During the 24 Weeks After Randomization

  Randomization to Week 24.

• Percent (%) Change of PASI Score From Randomization to Week 24

  Randomization to Week 24.

Study Arms (2)

etanercept

EXPERIMENTAL

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

Drug: Etanercept

placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Etanercept DRUG

Etanercept 50 mg QW initiated during taper of ciclosporin

Also known as: Enbrel

etanercept

Placebo OTHER

Randomized to placebo during taper of ciclosporin

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between age 18 and 70 years
• Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Publications (1)

• 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.

  PMID: 24682319 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 27, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 23, 2012
• Results First Posted: April 23, 2012

Record last verified: 2012-03