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Completed

NCT Number: NCT01737944

Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Pharmacokinetics (PK) study

Completed

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methotrexate (MTX)

Drug

Vibex MTX Device

Other names: Device with MTX

Primary outcomes

  1. 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

  2. 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

  3. Bioequivalence Based Upon Dose-Normalized Cmax for MTX

    Time frame: 24 Hour period

    Dose-normalized maximum observed concentration for each treatment

Sponsors and collaborators

Lead sponsor

Antares Pharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 30, 2012
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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