Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept
Source: ClinicalTrials.gov NCT01875991 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B |
41.7; 43.5; 36.8 | — |
| SECONDARY Change From Baseline in Needle Apprehension at Week 4 |
3.94; 4.00; 0.31; 0.39 | 0.501 |
| SECONDARY Ease of Use |
92.3; 96.1; 95.7; 90.8; 91.3; 88.9 | — |
| SECONDARY Certainty of Completing the Injection With the Autoinjector |
94.2; 87.9 | — |
| SECONDARY Convenience |
76.9; 86.5 | — |
| SECONDARY Discomfort |
56.3; 72.5 | — |
| SECONDARY Satisfaction |
79.8; 86.0; 66.8; 84.5 | — |
| SECONDARY Pain Associated With Use of the Autoinjector |
51.4; 65.2 | — |
| SECONDARY Strength of Preference for Autoinjector A and Autoinjector B |
45.9; 36.1; 43.5; 41.2; 5.9; 16.8 | — |
Eligibility Criteria
Inclusion Criteria: Diagnosis of moderate to severe Rheumatoid Arthritis (RA) or moderate to severe Plaque Psoriasis (PsO) and a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept. - Naive to etanercept. - Naive to other autoinjector pens or prefilled syringes for Tumor Necrosis Factor (TNF)-inhibitor therapy or other subcutaneous biologics for RA. - Willing to self-inject per investigator judgement at screening and capable of self-injection using the autoinjector A or B as documented at baseline by the investigator. - Able to read and write in English. -
Exclusion Criteria: Latex allergy. - Subject has an active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first 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 (NCT01875991). 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.