We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00440492
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : December 13, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: PLA-695 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis
Study Start Date : December 2006
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women of nonchildbearing potential with rheumatoid arthritis (RA), aged 18 to 75 years
  • RA disease onset after 16 years of age and has had the disease for at least 6 months
  • Must be receiving a stable, well-tolerated oral dose of methotrexate (5 to 25 mg) taken once weekly for at least 3 months

Exclusion Criteria:

  • Evidence of unstable clinically significant disease
Contacts and Locations

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): NCT00440492


Locations
United States, California
Los Angeles, California, United States, 90048
Palo Alto, California, United States, 94304
United States, New York
Lake Success, New York, United States, 11042
Rochester, New York, United States, 14642
United States, North Carolina
Charlotte, North Carolina, United States, 28208
United States, Ohio
Columbus, Ohio, United States, 43210
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Mississauga, Ontario, Canada, L4W 1N2
Canada, Quebec
Montreal, Quebec, Canada, H3P 3P1
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information

ClinicalTrials.gov Identifier: NCT00440492     History of Changes
Other Study ID Numbers: 3175A3-104
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: December 13, 2007
Last Verified: December 2007

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
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