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Enbrel Liquid Immunogenicity Protocol

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Amgen

Status and phase

Completed
Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Enbrel liquid
Drug: 50 mg Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00249041
20050145

Details and patient eligibility

About

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

Full description

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.

Enrollment

447 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

447 participants in 1 patient group

Etanercept liquid
Experimental group
Treatment:
Drug: Enbrel liquid
Drug: 50 mg Etanercept

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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