NCT01618955

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Antares Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.

Detailed description

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

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DEVICE	VIBEX MTX	Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-06-14
• Last updated: 2014-04-30
• Results posted: 2014-04-30

Locations

1 site across 1 country: United States