Etanercept SFP in RA Patients | NCT00413452

Studies
Etanercept SFP in RA Patients

NCT00413452

Sponsor

Amgen

Status

Completed

Last Update Posted

Feb 13, 2009Estimated

Enrollment

224Actual

Phase

Phase 3

Conditions

Rheumatoid Arthritis

Interventions

Etanercept

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Dec 15, 2006

First Submission Date that Met QC Criteria

Dec 15, 2006

First Posted Date

Dec 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2009

Last Update Posted Date

Feb 13, 2009Estimated

Name	Class
Wyeth is now a wholly owned subsidiary of Pfizer	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

224Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
50 mg	Experimental	50 mg once weekly	Drug: Etanercept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etanercept	Drug	50 mg once weekly	50 mg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
MD	Amgen	Study Director

Label	URL
FDA-approved Drug Labeling	View source
AmgenTrials clinical trials website	View source

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068800	Etanercept

Ancestor Terms

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided