Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept

Amgen

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis; Rheumatoid Arthritis

Treatments: Drug: Etanercept / Autoinjector A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01901185

20110107

Details and patient eligibility

About

The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept (Enbrel®).

Full description

Study participants need to have been self-administering etanercept for greater than or equal to 6 months prior to screening. You will be in this study for about 9 weeks. This includes a 4-week screening period and a 5-week treatment period.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has diagnosis of RA or PsA and indicated for treatment with etanercept per the current label, based on history.
• Subject is willing to self-inject per investigator judgement at screening.
• Subject has no known history of tuberculosis.

Exclusion criteria

• Latex allergy.
• Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first study dose of etanercept.
• Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.
• Other criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

Etanercept / Autoinjector A

Experimental group

Description:

Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).

Treatment:

Drug: Etanercept / Autoinjector A