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

Antares Pharma

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis (RA)

Treatments: Device: VIBEX MTX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01618955

MTX-11-002

Details and patient eligibility

About

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

Full 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

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

VIBEX MTX

Active Comparator group

Description:

VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status

Treatment:

Device: VIBEX MTX