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

Antares Pharma Inc.49 enrolled

Overview

Relative Bioavailability Comparison study

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis (RA)

Interventions

MTXDRUG

* Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group) * Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX) * Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Outcomes

Primary Outcomes

Dose-Normalized AUC[0-Inf] for MTX

Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment

Time frame: 24 Hour period

Dose-Normalized AUC[0-24] for MTX

Dose-normalized area under the curve from time zero to 24 hours (AUC\[0-24\]/Dose) for each treatment

Time frame: 24 Hour period

Dose-Normalized Cmax for MTX

Dose-normalized maximum observed concentration (Cmax) for each treatment

Time frame: 24 Hour period

Data from ClinicalTrials.gov

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