Clinical trial NCT00445770: Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
Official title: A Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-09
Enrollment: 550
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
timeFrame: Week 24
measure: Change From Baseline in Erosion Score at Weeks 24 and 52
timeFrame: Baseline, Week 24, and Week 52
measure: Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52
timeFrame: Baseline, Week 24, and Week 52
measure: Percentage of Participants With no Progression of Joint Destruction at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Percentage of Participants With an ACR50 Response
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Percentage of Participants With an ACR70 Response
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Other outcomes:
measure: Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses
timeFrame: Weeks 12, 24, 52
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Goshogawara
country: Japan
facility: Pfizer Investigational Site
state: Aomori
city: Asahi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Matsuyama
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Iizuka
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kurume
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kurume
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Munakata
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Takasaki
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Asahikawa
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Kakogawa
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Katoh
country: Japan
facility: Pfizer Investigational Site
state: Hyougo
city: Yuki
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Komatsu
country: Japan
facility: Pfizer Investigational Site
state: Ishikawa
city: Kawasaki
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Hyuga
country: Japan
facility: Pfizer Investigational Site
state: Miyazaki
city: Sasebo
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Ikoma
country: Japan
facility: Pfizer Investigational Site
state: Nara
city: Kawagoe
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Ota
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Sumida-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Fukui
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Kagoshima
country: Japan
facility: Pfizer Investigational Site
city: Kagoshima
country: Japan
facility: Pfizer Investigational Site
city: Kato city Fujita letter Higashiyama
country: Japan
facility: Pfizer Investigational Site
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Miyagi
country: Japan
facility: Pfizer Investigational Site
city: Miyazaki
country: Japan
facility: Pfizer Investigational Site
city: Toyama
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Takeuchi T, Miyasaka N, Pedersen RD, Sugiyama N, Hirose T. Radiographic and clinical effects of 10 mg and 25 mg twice-weekly etanercept over 52 weeks in Japanese patients with active rheumatoid arthritis. Mod Rheumatol. 2021 Mar;31(2):319-325. doi: 10.1080/14397595.2020.1805142. Epub 2020 Sep 7.
citation: Takeuchi T, Miyasaka N, Pedersen R, Sugiyama N, Hirose T. Radiographic and clinical outcomes following etanercept monotherapy in Japanese methotrexate-naive patients with active rheumatoid arthritis. Mod Rheumatol. 2020 Mar;30(2):259-268. doi: 10.1080/14397595.2019.1589918. Epub 2019 Mar 29.