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

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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®).

Research Team

Principal Investigator

Amgen

Eligibility Criteria

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.

Treatment Details

Interventions

Autoinjector A (Procedure)
Etanercept (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Etanercept / Autoinjector AExperimental Treatment1 Intervention

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).

Etanercept is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Enbrel for: