drugset

drugset / Trial / NCT01618968

Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device

NCT01618968 ↗

Phase 2 Completed 49 enrolled Antares Pharma Inc.

RandomizedCrossoverOpen-labelTreatment

Summary

Relative Bioavailability Comparison study

Timeline

Start: 2012-05
Primary completion: 2012-08
Completion: 2012-08

Publications

Schiff MH, Jaffe JS, Freundlich B. Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses >/=15 mg may be overcome with subcutaneous administration. Ann Rheum Dis. 2014 Aug;73(8):1549-51. doi: 10.1136/annrheumdis-2014-205228. Epub 2014 Apr 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methotrexate	Small molecule	10 mg	Subcutaneous
Subject	Methotrexate	Small molecule	15 mg	Subcutaneous
Subject	Methotrexate	Small molecule	20 mg	Subcutaneous
Subject	Methotrexate	Small molecule	25 mg	Subcutaneous

Indications