Enbrel Liquid Immunogenicity Protocol - Full Text View

Sponsors and Collaborators:	Amgen Immunex Corporation
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00249041

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 III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Immunoglobulins Globulin, Immune Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)

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
Etanercept liquid: Experimental	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

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

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050145
Study First Received:	November 3, 2005
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00249041
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Rheumatoid Arthritis, Enbrel liquid, antibodies

Study placed in the following topic categories:

Antibodies
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009