An Open-Label Study to Assess the Rate of Failure of an E... | NCT00346294

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

NCT00346294

Sponsor

Amgen

Status

Completed

Last Update Posted

Jan 22, 2020Actual

Enrollment

115Actual

Phase

Phase 4

Conditions

Rheumatoid Arthritis

Interventions

Etanercept

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Mar 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Jun 27, 2006

First Submission Date that Met QC Criteria

Jun 28, 2006

First Posted Date

Jun 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2020

Last Update Posted Date

Jan 22, 2020Actual

Name	Class
Immunex Corporation	INDUSTRY

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single-Arm	Other	Open-lable Single Arm Study	Drug: Etanercept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etanercept	Drug	Intervention type was to study the drug delivery method.	Single-Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

Not provided

Label	URL
FDA-approved Drug Labeling	View source
AmgenTrials clinical trials website	View source

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides