Phase 3
Completed N=77
Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept
Source: ClinicalTrials.gov NCT01901185 ↗Enrolled (actual)
77
Serious AEs
1.3%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Successful Self-injections to Total Non-missed Injections — 97.8 percentage of successful injections
Summary
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®).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Successful Self-injections to Total Non-missed Injections |
97.8 | — |
| SECONDARY Percentage of Autoinjector A System Failures |
2.4 | — |
| SECONDARY Percentage of Errors in Each Step of the Self-injection Process |
4.3; 1.9; 1.1; 1.6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01901185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.