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

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618968
• Other study ID #: MTX-11-003
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2012
• Last updated: May 8, 2014
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: May 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

Relative Bioavailability Comparison study

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• MTX
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)

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	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	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	24 Hour period	No
Primary	Dose-Normalized Cmax for MTX	Dose-normalized maximum observed concentration (Cmax) for each treatment	24 Hour period	No