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Exposure Study Comparing 3 Routes of Methotrexate 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: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

PK study


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Methotrexate
 Phase 1
Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Antares Pharma Inc.:

Primary Outcome Measures:
  • Bioavailablity comparison of methotrexate to VIBEX MTX [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10mg Methotrexate
10mg MTX
 Drug: Methotrexate
Experimental: 15mg Methotrexate
15mg MTX
 Drug: Methotrexate
Experimental: 20mg Methotrexate
20mg MTX
 Drug: Methotrexate
Experimental: 25mg Methotrexate
25mg MTX
 Drug: Methotrexate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or femael >18 years of age with diagnosed 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737944

Locations
United States, New York
The Center for Rheumatology, LLP
Albany, New York, United States, 12206
Sponsors and Collaborators
Antares Pharma Inc.
Investigators
Principal Investigator: Joel Kremer, MD The Center for Rheumatology, LLP
  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
Last Updated: November 28, 2012
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