Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Phase 1

Completed

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

• Registration Number: NCT01737944
• Lead Sponsor: Antares Pharma Inc.

Brief 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).

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-30
• Results First Submitted: 2013-01-25
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Results First Posted: 2014-02-25
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Male or female >18 years of age with diagnosed Rheumatoid Arthritis(RA).

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
25mg Methotrexate (MTX) Group	Methotrexate (MTX)	Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
10mg Methotrexate (MTX) Group	Methotrexate (MTX)	Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
15mg Methotrexate (MTX) Group	Methotrexate (MTX)	Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
20mg Methotrexate (MTX) Group	Methotrexate (MTX)	Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection

Primary Outcome Measures

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

Trial Locations

Locations (1)

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