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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis (RA)
• Interventions: Drug: MTX

• Registration Number: NCT01618968
• Lead Sponsor: Antares Pharma Inc.

Brief Summary

Relative Bioavailability Comparison study

Detailed 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

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-14
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2014-02-27
• Results First Submitted QC: 2014-04-09
• Status Verified: 2014-05
• Results First Posted: 2014-05-08
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Male or female patients ≥18 years of age, diagnosed with Rheumatoid Arthritis

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Exclusion Criteria

• Pregnant females
• Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
10 mg Methotrexate (MTX)	MTX	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.
20 mg MTX	MTX	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.
15 mg MTX	MTX	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.
25 mg MTX	MTX	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.

Primary Outcome Measures

Name	Time	Method
Dose-Normalized AUC[0-Inf] for MTX	24 Hour period	Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment
Dose-Normalized AUC[0-24] for MTX	24 Hour period	Dose-normalized area under the curve from time zero to 24 hours (AUC\[0-24\]/Dose) for each treatment
Dose-Normalized Cmax for MTX	24 Hour period	Dose-normalized maximum observed concentration (Cmax) for each treatment

Trial Locations

Locations (1)

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States