Enbrel Liquid Immunogenicity Protocol

NCT ID: NCT00249041

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

447 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis

Detailed Description

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The purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant MTX therapy. The rate of neutralizing antibodies to liquid etanercept will also be assessed.

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis, Enbrel liquid, antibodies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etanercept liquid

Group Type EXPERIMENTAL

50 mg Etanercept

Intervention Type DRUG

50 mg Etanercept liquid injected SC once weekly using prefilled syringes

Enbrel liquid

Intervention Type DRUG

50 mg Etanercept liquid injected SC once weekly using prefilled syringes

Interventions

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50 mg Etanercept

50 mg Etanercept liquid injected SC once weekly using prefilled syringes

Intervention Type DRUG

Enbrel liquid

50 mg Etanercept liquid injected SC once weekly using prefilled syringes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Must be able to self-inject or have someone who can do so for them
* Should have Rheumatoid Arthritis per ARA criteria and screening lab results per predefined value

Exclusion Criteria

* Any prior biologic therapy for inflammatory disease
* Any prior cyclophosphamide therapy
* Not using adequate contraception
* Pregnant or breast-feeding or any significant concurrent medical condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunex Corporation

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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Canada United States

References

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Kavanaugh A, Lee SJ, Weng HH, Chon Y, Huang XY, Lin SL. Patient-derived joint counts are a potential alternative for determining Disease Activity Score. J Rheumatol. 2010 May;37(5):1035-41. doi: 10.3899/jrheum.090704. Epub 2010 Feb 15.

Reference Type RESULT
PMID: 20156946 (View on PubMed)

Related Links

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http://www.enbrel.com/

FDA-approved Drug Labeling

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20050145

Identifier Type: -

Identifier Source: org_study_id