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Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

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ClinicalTrials.gov Identifier: NCT01737944
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.

Brief Summary:
Pharmacokinetics (PK) study

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Methotrexate (MTX) Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: 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 Name: 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 Name: Device with MTX



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737944


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

Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT01737944     History of Changes
Other Study ID Numbers: MTX-10-001
First Posted: November 30, 2012    Key Record Dates
Results First Posted: February 25, 2014
Last Update Posted: February 25, 2014
Last Verified: January 2014

Keywords provided by Antares Pharma Inc.:
methotrexate injection, subcutaneous, autoinjector

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
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