Rheumatoid Arthritis (RA) Clinical Trial
Official title:
Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
Primary objective:
- To assess the safe usability of the VIBEX MTX device for subcutaneous (SC) self-injection
of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) after standardized
training by site personnel and review of written instructions
Secondary objectives:
- To evaluate the reliability and robustness of the VIBEX MTX device
- To evaluate the safety and local tolerance of an SC self-injection of MTX using the
VIBEX MTX device
- To evaluate the effectiveness and ease of use of the VIBEX MTX device patient education
tools for SC self-injection
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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