Etanercept SFP in RA Patients

Amgen

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00413452

20060104

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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224 participants in 1 patient group

50 mg

Experimental group

Description:

50 mg once weekly

Treatment:

Drug: Etanercept