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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: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to compare methotrexate with VIBEX MTX.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Antares Pharma Inc.:

Primary Outcome Measures:
  • Relative Bioavailablity comparison of methotrexate to VIBEX MTX [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

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
Active Comparator: Methotrexate
Commercially available MTX
 Drug: Methotrexate
1 dose
Experimental: VIBEX MTX B
VIBEX MTX
 Drug: Methotrexate
1 dose
Experimental: VIBEX MTX C
VIBEX MTX
 Drug: Methotrexate
1 dose

  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 diagnosed with RA

Exclusion Criteria:

  • Pregnant females
  Contacts and Locations
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.
  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
Last Updated: January 25, 2013
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 May 21, 2013