NCT01737944

Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Exposure, Safety and Local Tolerance Study Comparing 3 Routes of Methotrexate (MTX) Administration: Vibex-MTX Device, Subcutaneous (SC)and Intramuscular (IM) in Adult Subjects With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Antares Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pharmacokinetics (PK) study

Detailed description

To compare the pharmacokinetic (PK) profiles of methotrexate (MTX) following a subcutaneous (SC) injection of MTX using the Vibex device to that obtained after an SC injection of MTX without using the device and to that obtained after an intramuscular (IM) injection of MTX in adult subjects with rheumatoid arthritis (RA).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Methotrexate (MTX)	Vibex MTX Device

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2012-11-30
• Last updated: 2014-02-25
• Results posted: 2014-02-25

Locations

1 site across 1 country: United States