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

Last updated on November 11, 2019

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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Descriptive Information
Brief Title  ICMJE Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis
Official Title  ICMJE 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
Brief SummaryCE 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
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: CE-224,535
  • Drug: Methotrexate
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 9, 2007)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion DateAugust 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00446784
Other Study ID Numbers  ICMJE A6341006
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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