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NCT00446784 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00446784
Other study ID # A6341006
Secondary ID
Status Completed
Phase Phase 1
First received March 9, 2007
Last updated May 19, 2011
Start date April 2007
Est. completion date August 2007

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CE-224,535

• Methotrexate

Locations
Country Name City State
United States Pfizer Investigational Site Ducansville Pennsylvania
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Ocala Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence and severity of adverse events throughout the study
Secondary Pharmacokinetics of CE 224,535 on Days 7 and 8
Secondary Pharmacokinetics of Methotrexate on Days 1 and 8
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