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Etanercept SFP in RA Patients

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Etanercept

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Etanercept, Enbrel, Amgen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

50 mg

Arm Description

50 mg once weekly

Outcomes

Primary Outcome Measures

Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)

Secondary Outcome Measures

Etanercept seroreactivity response to etanercept (manufactured using the SFP)

neutralizing antibodies to etanercept

Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments

Full Information

NCT ID

NCT00413452

First Posted

December 15, 2006

Last Updated

February 12, 2009

Sponsor

Amgen

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00413452

Brief Title

Etanercept SFP in RA Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Amgen

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Etanercept, Enbrel, Amgen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

224 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50 mg

Arm Type

Experimental

Arm Description

50 mg once weekly

Intervention Type

Drug

Intervention Name(s)

Etanercept

Intervention Description

50 mg once weekly

Primary Outcome Measure Information:

Title

Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Etanercept seroreactivity response to etanercept (manufactured using the SFP)

Time Frame

week 12

Title

neutralizing antibodies to etanercept

Time Frame

week 12 and 24

Title

Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments

Time Frame

week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Description

Notice regarding posted summaries of trial results

URL

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_916_ENBREL_20060104.pdf

Description

To access clinical trial results information click on this link

URL

http://www.enbrel.com/

Description

FDA-approved Drug Labeling

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

Etanercept SFP in RA Patients

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