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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01618968
First received: June 4, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

Relative Bioavailability Comparison study


Condition Intervention Phase
Rheumatoid Arthritis (RA)
Drug: MTX
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Antares Pharma Inc.:

Primary Outcome Measures:
  • Dose-Normalized AUC[0-Inf] for MTX [ Time Frame: 24 Hour period ] [ Designated as safety issue: No ]
    Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment

  • Dose-Normalized AUC[0-24] for MTX [ Time Frame: 24 Hour period ] [ Designated as safety issue: No ]
    Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment

  • Dose-Normalized Cmax for MTX [ Time Frame: 24 Hour period ] [ Designated as safety issue: No ]
    Dose-normalized maximum observed concentration (Cmax) for each treatment


Enrollment: 49
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 mg Methotrexate (MTX)
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
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)
Other Names:
  • Commercially available 2.5 mg MTX oral tablets
  • VIBEX MTX
Experimental: 15 mg MTX
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
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)
Other Names:
  • Commercially available 2.5 mg MTX oral tablets
  • VIBEX MTX
Experimental: 20 mg MTX
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
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)
Other Names:
  • Commercially available 2.5 mg MTX oral tablets
  • VIBEX MTX
Experimental: 25 mg MTX
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
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)
Other Names:
  • Commercially available 2.5 mg MTX oral tablets
  • VIBEX MTX

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618968

Locations
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Antares Pharma Inc.
Investigators
Principal Investigator: Alan J Kivitz, MD;CPI Altoona Center for Clinical Research
  More Information

No publications provided

Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT01618968     History of Changes
Other Study ID Numbers: MTX-11-003
Study First Received: June 4, 2012
Results First Received: February 27, 2014
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014