Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

January 8, 2014 updated by: Antares Pharma Inc.

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

Pharmacokinetics (PK) study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10mg Methotrexate (MTX) Group
Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
Drug: Methotrexate (MTX)
Vibex MTX Device
Other Names:
  • Device with MTX
Experimental: 15mg Methotrexate (MTX) Group
Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
Drug: Methotrexate (MTX)
Vibex MTX Device
Other Names:
  • Device with MTX
Experimental: 20mg Methotrexate (MTX) Group
Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
Drug: Methotrexate (MTX)
Vibex MTX Device
Other Names:
  • Device with MTX
Experimental: 25mg Methotrexate (MTX) Group
Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
Drug: Methotrexate (MTX)
Vibex MTX Device
Other Names:
  • Device with MTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX
Time Frame: 24 Hour period
Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment
24 Hour period
Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX
Time Frame: 24 Hour period
Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC[0-24]/Dose) for each treatment
24 Hour period
Bioequivalence Based Upon Dose-Normalized Cmax for MTX
Time Frame: 24 Hour period
Dose-normalized maximum observed concentration for each treatment
24 Hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antares Pharma Inc.

Investigators

  • Principal Investigator: Alan J Kivitz, MD;CPI, Altoona Center for Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTX-10-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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