NCT01163617

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Adalimumab delivered in current syringe	Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
DEVICE	Adalimumab delivered in Physiolis syringe	Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
DEVICE	Adalimumab delivered in current autoinjector	Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously
DEVICE	Adalimumab delivered in Physiolis autoinjector	Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-07-16
• Last updated: 2018-07-02
• Results posted: 2014-03-10

Locations

10 sites across 1 country: United States