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
NCT ID: NCT00965757
Last Updated: 2021-12-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
253 participants
INTERVENTIONAL
2009-07-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
T-614
T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.
2
Placebo
Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.
Interventions
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T-614
T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.
Placebo
Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.
Eligibility Criteria
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Inclusion Criteria
* Age greater or 20 years and less than 70 years old
Exclusion Criteria
* Women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant
20 Years
69 Years
ALL
No
Sponsors
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FUJIFILM Toyama Chemical Co., Ltd.
INDUSTRY
Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kota Nagai
Role: STUDY_DIRECTOR
JAC PCU. EPCS, Eisai Co., Ltd.
Locations
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Anjo, Aichi-ken, Japan
Ichinomiya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Okazaki, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Ichikawa, Chiba, Japan
Matsudo, Chiba, Japan
Narita, Chiba, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Maebashi, Gunma, Japan
Takasaki, Gunma, Japan
Asahikawa, Hokkaido, Japan
Chitose, Hokkaido, Japan
Hakodate, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Tomakomai, Hokkaido, Japan
Amagasaki, Hyōgo, Japan
Katō, Hyōgo, Japan
Kobe, Hyōgo, Japan
Hitachi, Ibaraki, Japan
Hitachi-Naka, Ibaraki, Japan
Tsukuba, Ibaraki, Japan
Kanazawa, Ishikawa-ken, Japan
Komatsu, Ishikawa-ken, Japan
Morioka, Iwate, Japan
Kirishima, Kagoshima-ken, Japan
Kawasaki, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Tamana, Kumamoto, Japan
Miyagi-gun, Miyagi, Japan
Sendai, Miyagi, Japan
Hyūga, Miyazaki, Japan
Isahaya, Nagasaki, Japan
Sasebo, Nagasaki, Japan
Ikoma, Nara, Japan
Higashiosaka, Osaka, Japan
Hirakata, Osaka, Japan
Takatsuki, Osaka, Japan
Hiki-gun, Saitama, Japan
Iruma, Saitama, Japan
Kawaguchi, Saitama, Japan
Tokorozawa, Saitama, Japan
Matsue, Shimane, Japan
Nasushiobara, Tochigi, Japan
Oyama, Tochigi, Japan
Shimotsuke, Tochigi, Japan
Yoshinogawa, Tokushima, Japan
Chiyoda City, Tokyo, Japan
Edogawa City, Tokyo, Japan
Otaku, Tokyo, Japan
Setagaya City, Tokyo, Japan
Sumida City, Tokyo, Japan
Takaoka, Toyama, Japan
Tonami, Toyama, Japan
Yonezawa, Yamagata, Japan
Hōfu, Yamaguchi, Japan
Fukuoka, , Japan
Gifu, , Japan
Hiroshima, , Japan
Kagashima, , Japan
Kagoshima, , Japan
Kochi, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Nagano, , Japan
Nagasaki, , Japan
Osaka, , Japan
Ōita, , Japan
Saitama, , Japan
Shizuoka, , Japan
Tokushima, , Japan
Countries
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Other Identifiers
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T614-ADN
Identifier Type: -
Identifier Source: org_study_id