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Completed

NCT Number: NCT01618968

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

Relative Bioavailability Comparison study

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Key information

Conditions

Rheumatoid Arthritis (RA) 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 2

Primary location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MTX

Drug
  • 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)

Other names: Commercially available 2.5 mg MTX oral tablets, VIBEX MTX

Primary outcomes

  1. 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. Dose-Normalized AUC[0-24] for MTX

    Time frame: 24 Hour period

    Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment

  3. Dose-Normalized Cmax for MTX

    Time frame: 24 Hour period

    Dose-normalized maximum observed concentration (Cmax) for each treatment

Sponsors and collaborators

Lead sponsor

Antares Pharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2012
Registry last updated
May 19, 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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