Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Rheumatoid Arthritis Clinical Trial

Official title:

Exposure, Safety and Local Tolerance Study Comparing 3 Routes of Methotrexate (MTX) Administration: Vibex-MTX Device, Subcutaneous (SC)and Intramuscular (IM) in Adult Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737944
• Other study ID #: MTX-10-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 27, 2012
• Last updated: January 8, 2014
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: January 2014
• Source: Antares Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Pharmacokinetics (PK) study

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Methotrexate (MTX)
Vibex MTX Device

Locations

Country	Name	City	State
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Antares Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence Based Upon 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	24 Hour period	No
Primary	Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX	Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC[0-24]/Dose) for each treatment	24 Hour period	No
Primary	Bioequivalence Based Upon Dose-Normalized Cmax for MTX	Dose-normalized maximum observed concentration for each treatment	24 Hour period	No