Clinical trial NCT00965757: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: FUJIFILM Toyama Chemical Co., Ltd.
First posted: 2009-08-26
Enrollment: 253
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
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 evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis


Eligibility criteria: Inclusion criteria:

* Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria
* Age greater or 20 years and less than 70 years old

Exclusion criteria:

* Subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant

Primary outcomes:
measure: Percentage of American College of Rheumatology [ACR] 20 Criteria Responders
timeFrame: Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)
Secondary outcomes:
measure: Change From Baseline in Tender Joint Counts and Swollen Joint Counts
timeFrame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
measure: Change From Baseline in PAP, PtGADA and PyGADA
timeFrame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
measure: Change From Baseline in C-reactive Protein (CRP)
timeFrame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
measure: Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)
timeFrame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
measure: Percentage of ACR 50 Criteria Responders
timeFrame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
measure: Percentage of ACR 70 Criteria Responders
timeFrame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Other outcomes:
Locations:
city: Anjo
country: Japan
state: Aichi
city: Ichinomiya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Okazaki
country: Japan
state: Aichi
city: Toyohashi
country: Japan
state: Aichi
city: Ichikawa
country: Japan
state: Chiba
city: Matsudo
country: Japan
state: Chiba
city: Narita
country: Japan
state: Chiba
city: Kitakyusyu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Maebashi
country: Japan
state: Gunma
city: Takasaki
country: Japan
state: Gunma
city: Asahikawa
country: Japan
state: Hokkaido
city: Chitose
country: Japan
state: Hokkaido
city: Hakodate
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Tomakomai
country: Japan
state: Hokkaido
city: Amagasaki
country: Japan
state: Hyogo
city: Kato
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Hitachinaka
country: Japan
state: Ibaraki
city: Hitachi
country: Japan
state: Ibaraki
city: Tsukuba
country: Japan
state: Ibaraki
city: Kanazawa
country: Japan
state: Ishikawa
city: Komatsu
country: Japan
state: Ishikawa
city: Morioka
country: Japan
state: Iwate
city: Kirishima
country: Japan
state: Kagoshima
city: Kawasaki
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Tamana
country: Japan
state: Kumamoto
city: Miyagi-gun
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Hyuga
country: Japan
state: Miyazaki
city: Isahaya
country: Japan
state: Nagasaki
city: Sasebo
country: Japan
state: Nagasaki
city: Ikoma
country: Japan
state: Nara
city: Higashiosaka
country: Japan
state: Osaka
city: Hirakata
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Hiki-gun
country: Japan
state: Saitama
city: Iruma
country: Japan
state: Saitama
city: Kawaguchi
country: Japan
state: Saitama
city: Tokorozawa
country: Japan
state: Saitama
city: Matsue
country: Japan
state: Shimane
city: Nasushiobara
country: Japan
state: Tochigi
city: Oyama
country: Japan
state: Tochigi
city: Shimotsuke
country: Japan
state: Tochigi
city: Yoshinogawa
country: Japan
state: Tokushima
city: Chiyoda
country: Japan
state: Tokyo
city: Edogawa
country: Japan
state: Tokyo
city: Otaku
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Sumida
country: Japan
state: Tokyo
city: Takaoka
country: Japan
state: Toyama
city: Tonami
country: Japan
state: Toyama
city: Yonezawa
country: Japan
state: Yamagata
city: Hofu
country: Japan
state: Yamaguchi
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Kagashima
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Nagano
country: Japan
city: Nagasaki
country: Japan
city: Oita
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Shizuoka
country: Japan
city: Tokushima
country: Japan
Study officials:
affiliation: JAC PCU. EPCS, Eisai Co., Ltd.
name: Kota Nagai
role: STUDY_DIRECTOR
References: