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

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ClinicalTrials.gov Identifier: NCT01618968
Recruitment Status : Completed
First Posted : June 14, 2012
Results First Posted : May 8, 2014
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.

Brief Summary:
Relative Bioavailability Comparison study

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01618968


Locations
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United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Antares Pharma Inc.
Investigators
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Principal Investigator: Alan J Kivitz, MD;CPI Altoona Center for Clinical Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT01618968    
Other Study ID Numbers: MTX-11-003
First Posted: June 14, 2012    Key Record Dates
Results First Posted: May 8, 2014
Last Update Posted: May 19, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases