An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00346294

Enrollment

115

Registered

2006-06-29

Start date

2006-01-31

Completion date

2006-07-31

Last updated

2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Device, Auto-injector, SureClick, Enbrel, Etanercept

Brief summary

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

Interventions

DRUGEtanercept

Intervention type was to study the drug delivery method.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Diagnosis of rheumatoid arthritis * RA subjects * 18 years or older * Currently taking etanercept in pre-filled syringes for at least 4 weeks * Subjects must give written informed consent * Subjects must be able to read and write in English

Exclusion criteria

- Subject is not using adequate contraception * Subject is pregnant or breast feeding * Significant concurrent medical diseases

Design outcomes

Primary

Measure	Time frame
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.	22 Days

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026