Enbrel Liquid Immunogenicity Protocol

Amgen447 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

447

Conditions

Rheumatoid Arthritis

Interventions

50 mg EtanerceptDRUG

50 mg Etanercept liquid injected SC once weekly using prefilled syringes

Enbrel liquidDRUG

50 mg Etanercept liquid injected SC once weekly using prefilled syringes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24

Time frame: 24 weeks

Secondary Outcomes

Rates of anti-etanercept antibody formation to etanercept liquid at week 12, and the rates of neutralizing antibodies at Weeks 12 and 24. Safety of etanercept liquid in RA subjects receiving 50 mg once weekly up to 24 weeks.

Time frame: 12 weeks and 24 weeks

Data from ClinicalTrials.gov

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