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

• Subjects' overall satisfaction with the drug administration experience using the Physiolis syringe/autoinjector in comparison to the current syringe/autoinjector [ Time Frame: Phase A (Week 0 and Week 2) ] [ Designated as safety issue: No ]
  Subject's overall satisfaction of the injection was collected on a 10-cm visual analog scale (VAS) completed by subjects immediately after self-injection. 0 = extremely unsatisfied, 10 = extremely satisfied
  
  
• Injection time for the Physiolis autoinjector at room temperature and at storage temperature compared to the current autoinjector ejection time specification of not more than 10 seconds [ Time Frame: Phase B (Week 4) ] [ Designated as safety issue: No ]
  A health care provider administered the injection to the subject, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible "click," until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2 to 8 C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20 to 27 C).
  
  

• Difference in injection time for the current autoinjector compared to the Physiolis autoinjector [ Time Frame: Phase B (Week 4) ] [ Designated as safety issue: No ]
  A health care provider administered the injection to the subject, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible "click," until the yellow indicator stopped moving in the autoinjector view window). Injections were administered at room temperature (20 to 27 C).
  
  
• Difference in injection time for the current autoinjector when administered at room temperature versus the storage temperature [ Time Frame: Phase B (Week 4) ] [ Designated as safety issue: No ]
  A health care provider administered the injection to the subject, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible "click," until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2 to 8 C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20 to 27 C).
  
  

The study consisted of 2 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 the commercially available ("current") autoinjector, or the Physiolis syringe and current syringe. Phase B (Injection Time) was a randomized, single-visit, parallel-arm phase, with an in vitro injection followed by a single in vivo SC injection of the Physiolis autoinjector or current autoinjector administered at 2 different temperature ranges. In Phase A, subject assignment to the autoinjector or syringe arms was to depend on whether they were current autoinjector or syringe users. At Visit 1, subjects were randomly assigned in a 1:1 ratio to 1 of 4 treatment regimens and performed a self-injection using either the Physiolis syringe or autoinjector or the current syringe or autoinjector. At Visit 2, subjects who had previously received the current autoinjector or syringe performed a self-injection with the Physiolis autoinjector or syringe, and vice versa. Thus, during Phase A, every subject who was an autoinjector user was to inject with both the current autoinjector and the Physiolis autoinjector, and every subject who was a syringe user was to inject with both the current syringe and the Physiolis syringe. Subjects evaluated their overall satisfaction, usability, and pain of each injection. Phase B began on Visit 3. Subjects were re-randomized in a 1:1:1:1 ratio to 1 of 4 treatment regimens. Subjects received a single SC injection administered by a health care provider using either the Physiolis autoinjector or current autoinjector at 1 of 2 different temperature ranges: room temperature (20° to 27°C) or storage temperature (2° to 8°C). Injection durations were recorded for this injection as well as for an in vitro injection (i.e., into a test tube) at the same temperature. Subjects evaluated their pain from the injection.