NCT00111436

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
912

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

2.3 years

First QC Date

May 20, 2005

Last Update Submit

April 24, 2013

Conditions

Psoriasis

Keywords

Psoriasis, adults, skinPhase 3, clinical trialAmgen, etanerceptEnbrel®, moderatesevere, extension

Outcome Measures

Primary Outcomes (2)

  • Subject incidence of adverse events, including infectious episodes

    72 weeks

  • Changes from baseline in laboratory values

    72 weeks

Secondary Outcomes (5)

  • Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study

    72 weeks

  • Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis

    72 weeks

  • Patient Global Assessment of psoriasis

    72 weeks

  • Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores

    72 weeks

  • Changes from baseline in SF-36 Health Survey scores

    72 weeks

Study Arms (2)

50 mg

EXPERIMENTAL

50 mg once weekly

Drug: Etanercept

100 mg

EXPERIMENTAL

50 mg twice weekly

Drug: Etanercept

Interventions

EtanerceptDRUG

Enbrel 50 mg once weekly or 50 mg twice weekly

100 mg50 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
  • Pregnant or breast-feeding females
  • Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Elewski B, Leonardi C, Gottlieb AB, Strober BE, Simiens MA, Dunn M, Jahreis A. Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis. Br J Dermatol. 2007 Jan;156(1):138-42. doi: 10.1111/j.1365-2133.2006.07585.x.

    PMID: 17199580RESULT

  • Leonardi C, Strober B, Gottlieb AB, Elewski BE, Ortonne JP, van de Kerkhof P, Chiou CF, Dunn M, Jahreis A. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. J Drugs Dermatol. 2010 Aug;9(8):928-37.

    PMID: 20684143RESULT

Related Links

MeSH Terms

Conditions

PsoriasisLymphoma, Follicular

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2005

First Posted

May 23, 2005

Study Start

April 1, 2003

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

April 26, 2013

Record last verified: 2013-04