NCT00110903

Brief Summary

The purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with RA.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2005

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

First QC Date

May 16, 2005

Last Update Submit

April 24, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisRAetanerceptImmunexAmgen

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects having positive immunoassay response to etanercept liquid during the treatment period.

Secondary Outcomes (2)

  • Incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes

  • Measurements from safety laboratory assessments.

Interventions

Etanercept LiquidDRUG

Eligibility Criteria

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

You may qualify if:

  • AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dL;
  • Platelet count greater than or equal to 125,000/cm3;
  • White blood cell count (WBC) greater than or equal to 3500 cells/cm3;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Dore RK, Mathews S, Schechtman J, Surbeck W, Mandel D, Patel A, Zhou L, Peloso P. The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2007 Jan-Feb;25(1):40-6.

    PMID: 17417989RESULT

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 16, 2005

First Posted

May 17, 2005

Last Updated

April 26, 2013

Record last verified: 2013-04