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

January 17, 2020 updated by: Amgen
An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Single-Arm
Open-lable Single Arm Study
Drug: Etanercept
Intervention type was to study the drug delivery method.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.
Time Frame: 22 Days
22 Days
To determine the rate of failed drug deliveries (as opposed to device failures).
Time Frame: 22 Days
22 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

Immunex Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

March 1, 2006

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 28, 2006

First Posted (ESTIMATE)

June 29, 2006

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

3
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