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Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01737944
First received: November 27, 2012
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

Pharmacokinetics (PK) study


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Methotrexate (MTX)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Antares Pharma Inc.:

Primary Outcome Measures:
  • Bioequivalence Based Upon 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

  • Bioequivalence Based Upon 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 post-dose (AUC[0-24]/Dose) for each treatment

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


Enrollment: 38
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT01737944     History of Changes
Other Study ID Numbers: MTX-10-001
Study First Received: November 27, 2012
Results First Received: January 25, 2013
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014