Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device

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

Inclusion Criteria:

• Male or female patients >18 years of age, diagnosed with Rheumatoid Arthritis

Exclusion Criteria:

• Pregnant females
• Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk