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

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00440492

Purpose

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

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: PLA-695	Phase I

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.

Study Start Date:	December 2006
Study Completion Date:	November 2007

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440492

Locations

United States, California

Palo Alto, California, United States, 94304

Los Angeles, California, United States, 90048
United States, New York

Rochester, New York, United States, 14642

Lake Success, New York, United States, 11042
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

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3175A3-104
Study First Received:	February 23, 2007
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00440492
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009