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CompletedNCT00446784Updated May 23, 2011

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

A Phase 1 interventional study of CE-224,535 and Methotrexate in Arthritis, Rheumatoid, sponsored by Pfizer. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-23.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Arthritis, Rheumatoid
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 20 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
20 participants

Interventions

  • DrugCE-224,535
  • DrugMethotrexate
06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events throughout the study

Secondary outcomes

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

  2. Pharmacokinetics of Methotrexate on Days 1 and 8

07

Study locations

5 sites
  • Pfizer Investigational Site
    Miami, Florida 33169, United States
  • Pfizer Investigational Site
    Ocala, Florida 34471, United States
  • Pfizer Investigational Site
    Ocala, Florida 34474, United States
  • Pfizer Investigational Site
    Kalamazoo, Michigan 49007, United States
  • Pfizer Investigational Site
    Ducansville, Pennsylvania 16635, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00446784
Lead sponsor
Pfizer
First posted
Mar 13, 2007
Start date
Apr 2007
Primary completion
Aug 2007
Completion
Aug 2007
Last update
May 23, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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