An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis

Amgen

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00346294

20050207

Details and patient eligibility

About

An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Diagnosis of rheumatoid arthritis

• RA subjects
• 18 years or older
• Currently taking etanercept in pre-filled syringes for at least 4 weeks
• Subjects must give written informed consent
• Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception
• Subject is pregnant or breast feeding
• Significant concurrent medical diseases

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

Single-Arm

Other group

Description:

Open-lable Single Arm Study

Treatment:

Drug: Etanercept