Etanercept SFP in RA Patients

February 12, 2009 updated by: Amgen

Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.

Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA
  • Naïve to etanercept therapy
  • Able to self-inject investigational product or have a designee who can do so
  • Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria
  • Receipt of Corticosteroids> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product
  • Receipt of MTX witin 30 days of 1st dose of investigational product
  • Receipt of an other investigational drug within 30 days of 1st dose
  • Receipt of TNF inhibitor therapy within 90 days of 1st dose
  • Receipt of cyclophosphamide within 6 mo of 1st dose
  • Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum recommended dose in the product info sheet
  • Current use of insulin
  • gnificant concurrent medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 50 mg
50 mg once weekly
Drug: Etanercept
50 mg once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Etanercept seroreactivity response to etanercept (manufactured using the SFP)
Time Frame: week 12
week 12
neutralizing antibodies to etanercept
Time Frame: week 12 and 24
week 12 and 24
Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments
Time Frame: week 24
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

December 15, 2006

First Submitted That Met QC Criteria

December 15, 2006

First Posted (Estimate)

December 19, 2006

Study Record Updates

Last Update Posted (Estimate)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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