Last reviewed · How we verify
An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis
A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis.
Details
| Lead sponsor | Samsung Bioepis Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 49 |
| Start date | 2015-09 |
| Completion | 2016-03 |
Conditions
- Rheumatoid Arthritis
Interventions
- Adalimumab PFS and Pen
Primary outcomes
- The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale — Difference of injection site pain score (Week 6 - Week 2)
Injection site pain evaluation questionnaire will be rated on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as it could be) at two-time points post-injection (immediately post-injection and between 15 to 30 minutes post-injection) at Weeks 0, 2, 4, and 6.
Countries
Poland