The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

Official title: A Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis Patients

Status Completed

Clinical Trial Summary

This was an open-label, Phase 2 study designed to obtain user experience data (Phase A) and injection time data (Phase B) in experienced adalimumab patients injected with the Physiolis pre-filled syringe and autoinjector used to administer adalimumab.

Clinical Trial Description

This was a Phase 2, open-label study consisting of 2 study phases with a total of 3 study visits, each visit occurring 2 weeks apart from each other. Phase A (User Experience) was a randomized, 2-period, cross-over phase in which single subcutaneous (SC) dose injections were administered using either the Physiolis autoinjector and current autoinjector or the Physiolis syringe and current syringe in a 1:1 ratio. Phase B (Injection Time) was a randomized, single-visit, parallel-arm phase, with injection into a test tube, and one SC injection given to participants using the Physiolis autoinjector or current autoinjector administered at 2 different temperature ranges (2° to 8°C [storage temperature] and 20° to 27°C [room temperature]). If a participant only completed Visit 1 and Visit 2, then the participant was to be replaced for Visit 3. If the participant only completed Visit 1, the participant was to be replaced for all study visits. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT01163617
• Study type: Interventional
• Source: AbbVie
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Completion date: November 2010