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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00446784

Enrollment

Registered

2007-03-13

Start date

2007-04-30

Completion date

2007-08-31

Last updated

2011-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

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

Interventions

DRUGCE-224,535

DRUGMethotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events throughout the study	—

Secondary

Measure	Time frame
Pharmacokinetics of CE 224,535 on Days 7 and 8	—
Pharmacokinetics of Methotrexate on Days 1 and 8	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026