NCT00346294

Brief Summary

An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_4 rheumatoid-arthritis

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

January 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

June 27, 2006

Last Update Submit

January 17, 2020

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisDeviceAuto-injectorSureClickEnbrelEtanercept

Outcome Measures

Primary Outcomes (1)

  • To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.

    22 Days

Secondary Outcomes (2)

  • To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.

    22 Days

  • To determine the rate of failed drug deliveries (as opposed to device failures).

    22 Days

Study Arms (1)

Single-Arm

OTHER

Open-lable Single Arm Study

Drug: Etanercept

Interventions

EtanerceptDRUG

Intervention type was to study the drug delivery method.

Single-Arm

Eligibility Criteria

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

You may qualify if:

  • RA subjects
  • years or older
  • Currently taking etanercept in pre-filled syringes for at least 4 weeks
  • Subjects must give written informed consent

You may not qualify if:

  • Subject is pregnant or breast feeding
  • Significant concurrent medical diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 29, 2006

Study Start

January 1, 2006

Primary Completion

March 1, 2006

Study Completion

July 1, 2006

Last Updated

January 22, 2020

Record last verified: 2020-01