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Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CE-224,535
Methotrexate
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults patients with rheumatoid arthritis
  • Patients who have received stable weekly doses of oral methotrexate (5 to 25 mg/week administered as a single dose) for a minimum of 28 days (4 weeks/4 doses)

Exclusion Criteria:

  • History of chronic infectious disease such as genitourinary, pulmonary or sinus infections.
  • Any current or known malignancy or history of malignancy within the previous 5 years
  • Pregnant or lactating women; women of child-bearing potential who are unwilling to unable to use an acceptable method of birth control during the study

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events throughout the study

Secondary Outcome Measures

Pharmacokinetics of CE 224,535 on Days 7 and 8
Pharmacokinetics of Methotrexate on Days 1 and 8

Full Information

First Posted
March 9, 2007
Last Updated
May 19, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00446784
Brief Title
Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis
Official Title
A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already receiving methotrexate

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CE-224,535
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events throughout the study
Secondary Outcome Measure Information:
Title
Pharmacokinetics of CE 224,535 on Days 7 and 8
Title
Pharmacokinetics of Methotrexate on Days 1 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults patients with rheumatoid arthritis Patients who have received stable weekly doses of oral methotrexate (5 to 25 mg/week administered as a single dose) for a minimum of 28 days (4 weeks/4 doses) Exclusion Criteria: History of chronic infectious disease such as genitourinary, pulmonary or sinus infections. Any current or known malignancy or history of malignancy within the previous 5 years Pregnant or lactating women; women of child-bearing potential who are unwilling to unable to use an acceptable method of birth control during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Pfizer Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Pfizer Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Pfizer Investigational Site
City
Ducansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6341006&StudyName=Study%20Of%20The%20Safety%20Of%20CE%20224%2C545%20And%20Methotrexate%20In%20Patients%20With%20Rheumatoid%20Arthritis
Description
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Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

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