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Enbrel Liquid Immunogenicity Protocol

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00249041
First received: November 3, 2005
Last updated: July 29, 2010
Last verified: July 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: 50 mg Etanercept
Drug: Enbrel liquid
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)

Resource links provided by NLM:

Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 447
Study Start Date: October 2005
Study Completion Date: March 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etanercept liquid Drug: 50 mg Etanercept
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
Drug: Enbrel liquid
50 mg Etanercept liquid injected SC once weekly using prefilled syringes

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249041

Sponsors and Collaborators
Amgen
Immunex Corporation
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00249041     History of Changes
Other Study ID Numbers: 20050145
Study First Received: November 3, 2005
Last Updated: July 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Rheumatoid Arthritis, Enbrel liquid, antibodies

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013