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Trial record 1 of 1 for:    NCT00440492
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Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00440492
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : December 13, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE February 23, 2007
First Posted Date  ICMJE February 27, 2007
Last Update Posted Date December 13, 2007
Study Start Date  ICMJE December 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February¬†26,¬†2007)
To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00440492 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis
Official Title  ICMJE An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis
Brief Summary The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE Drug: PLA-695
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00440492
Other Study ID Numbers  ICMJE 3175A3-104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP