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

Antares Pharma

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: MTX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01618968

MTX-11-003

Details and patient eligibility

About

Relative Bioavailability Comparison study

Full description

A Phase 2, Open-Label, Randomized, 3-Way Crossover Study to Compare the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis

Enrollment: 49 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: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 4 patient groups

10 mg Methotrexate (MTX)

Experimental group

Description:

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

Treatment:

Drug: MTX

15 mg MTX

Experimental group

Description:

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

Treatment:

Drug: MTX

20 mg MTX

Experimental group

Description:

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

Treatment:

Drug: MTX

25 mg MTX

Experimental group

Description:

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

Treatment:

Drug: MTX