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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami, Florida, 33169 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00446784
Pfizer
Completed
Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

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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
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: CE-224,535
  • Drug: Methotrexate
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2007
August 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00446784
A6341006
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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