NCT00446784

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 23, 2011

Status Verified

May 1, 2011

Enrollment Period

4 months

First QC Date

March 9, 2007

Last Update Submit

May 19, 2011

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events throughout the study

Secondary Outcomes (2)

  • Pharmacokinetics of CE 224,535 on Days 7 and 8

  • Pharmacokinetics of Methotrexate on Days 1 and 8

Interventions

CE-224,535DRUG
MethotrexateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Miami, Florida, 33169, United States

Location

Pfizer Investigational Site

Ocala, Florida, 34471, United States

Location

Pfizer Investigational Site

Ocala, Florida, 34474, United States

Location

Pfizer Investigational Site

Kalamazoo, Michigan, 49007, United States

Location

Pfizer Investigational Site

Ducansville, Pennsylvania, 16635, United States

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

CE 224,535Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 9, 2007

First Posted

March 13, 2007

Study Start

April 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

May 23, 2011

Record last verified: 2011-05

Locations

US(5)