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

NCT00445770

Last updated date
Study Location
Pfizer Investigational Site
Nagoya, Aichi, 460-0001, Japan
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
Official Title  ICMJE A Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid Arthritis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Etanercept
  • Experimental: 2
    Intervention: Drug: Etanercept
  • Active Comparator: 3
    Intervention: Drug: Methotrexate
Publications * Takeuchi T, Miyasaka N, Pedersen R, Sugiyama N, Hirose T. Radiographic and clinical outcomes following etanercept monotherapy in Japanese methotrexate-naïve patients with active rheumatoid arthritis. Mod Rheumatol. 2020 Mar;30(2):259-268. doi: 10.1080/14397595.2019.1589918. Epub 2019 Mar 29.

*   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
Actual Enrollment  ICMJE
 (submitted: September 24, 2010)
550
Original Enrollment  ICMJE
 (submitted: March 8, 2007)
540
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 75 Years   (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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00445770
Other Study ID Numbers  ICMJE 0881A1-315
B1801002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP