Auto-injector Real Life Handling in Patients
- Sponsor
- Alvotech Swiss AG
- Study ID
- NCT04224194
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Adalimumab — COMBINATION_PRODUCTCombined product as Drug is delivered through an autoinjector pen on which real-life patient handling experience is assessed.
Study Details
To assess the real-life patient handling experience with the use of an autoinjector in patients with moderate to severe active Rheumatoid Arthritis (RA) who self-inject AVT02 subcutaneously (SC).
Key Dates
- Start date
- Nov 4, 2019
- Status verified
- Jun 2021
- Primary completion
- Jul 8, 2020
- Completion
- Feb 26, 2021
Study Design
- Enrollment
- 107 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Interventional, Single arm to evaluate autoinjector handlingTo assess the real-life patient handling experience with the use of an autoinjector in patients with moderate to severe active Rheumatoid Arthritis (RA) who selfinject AVT02 (adalimumab) subcutaneously (SC).
Primary Outcome Measure
percentage of successful self-injections patient rated [ Time Frame: up to the Week 8 ]