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Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Nagoya, Aichi, 460-0001 Japan
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
20-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must be Japanese and live in Japan

- Must be age 20 to 75 years

- Diagnosed less than or equal to 10 years from time of first visit

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

- Anyone who has received etanercept or TNF-inhibitors such as infliximab or adalimumab
in the past

- Patient with other rheumatic diseases or conditions that could predispose the patient
to infection

- Pregnant or lactating women

NCT00445770
Pfizer
Completed
Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

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Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
A Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid Arthritis
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: Etanercept
    10 mg twice weekly, subcutaneous injection for 52 weeks
  • Drug: Etanercept
    25 mg, twice weekly, subcutaneous injection for 52 weeks
  • Drug: Methotrexate
    up to 8 mg per week, oral dosing for 52 weeks
  • Experimental: 1
    Intervention: Drug: Etanercept
  • Experimental: 2
    Intervention: Drug: Etanercept
  • Active Comparator: 3
    Intervention: Drug: Methotrexate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
550
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be Japanese and live in Japan
  • Must be age 20 to 75 years
  • Diagnosed less than or equal to 10 years from time of first visit

Exclusion Criteria:

  • Anyone who has received etanercept or TNF-inhibitors such as infliximab or adalimumab in the past
  • Patient with other rheumatic diseases or conditions that could predispose the patient to infection
  • Pregnant or lactating women
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00445770
0881A1-315
B1801002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 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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