Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device
NCT ID: NCT01618955
Last Updated: 2014-04-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2012-05-31
2012-07-31
Brief Summary
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Detailed Description
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\- To assess the safe usability of the VIBEX MTX device for subcutaneous (SC) self-injection of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) after standardized training by site personnel and review of written instructions
Secondary objectives:
* To evaluate the reliability and robustness of the VIBEX MTX device
* To evaluate the safety and local tolerance of an SC self-injection of MTX using the VIBEX MTX device
* To evaluate the effectiveness and ease of use of the VIBEX MTX device patient education tools for SC self-injection
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VIBEX MTX
VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status
VIBEX MTX
Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device
Interventions
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VIBEX MTX
Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk
18 Years
ALL
No
Sponsors
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Antares Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alan J Kivitz, MD;CPI
Role: PRINCIPAL_INVESTIGATOR
Altoona Center for Clinical Research
Locations
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Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Countries
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Other Identifiers
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MTX-11-002
Identifier Type: -
Identifier Source: org_study_id