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

NCT ID: NCT00440492

Last Updated: 2007-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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PLA-695

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Los Angeles, California, United States

Site Status

Palo Alto, California, United States

Site Status

Lake Success, New York, United States

Site Status

Rochester, New York, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Columbus, Ohio, United States

Site Status

Vancouver, British Columbia, Canada

Site Status

Mississauga, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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3175A3-104

Identifier Type: -

Identifier Source: org_study_id