Etanercept SFP in RA Patients

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00413452

Enrollment

224

Registered

2006-12-19

Start date

2006-12-31

Completion date

2007-10-31

Last updated

2009-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Etanercept, Enbrel, Amgen

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.

Interventions

DRUGEtanercept

50 mg once weekly

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	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	week 24

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026