A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis
NCT ID: NCT00484289
Last Updated: 2013-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
217 participants
INTERVENTIONAL
2006-12-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1: Participants from Phase I study (IM101-034)
Abatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants \> 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
Arm 2: Participants from Phase II study (IM101-071)
Abatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants \> 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
Arm 3: New Participants with Methotrexate (MTX) Intolerance
Abatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants \> 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
Interventions
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Abatacept
Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants \> 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The participants of the Phase I study (IM101-034), who received abatacept, except participants who were withdrawn from the study due to safety problems related to abatacept.
* New subjects with MTX intolerance: rheumatoid arthritis (RA) patients to whom MTX cannot be administered for safety reasons and who present an inadequate response to disease-modifying antirheumatic drugs (DMARDs;excluding MTX) or biologics (new subjects with MTX intolerance: RA patients who present an inadequate response to DMARDs).
Exclusion Criteria
* Participants who have received non approved or investigational biologics (other than abatacept from previous or ongoing studies in Japan) at registration.
* Participants who have received treatment with any investigational drug within 56 days before registration or five half-lives (whichever is the longest).
* Participants currently receiving treatment with leflunomide, mycophenolate mofetil, calcineurine inhibitors such as cyclosporine and tacrolimus, D-Penicillamine, Cyclophosphamide, or immunoadsorption columns.
* The participants who completed Phase II (IM101-071) are not applicable in the following instances at time of registration: with active vasculitis, symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of cancer within the last 5 years, evidence of active or latent bacterial , viral infections, any serious or chronic, at risk of tuberculosis (TB), with any opportunistic infections, laboratory values of hemoglobin \< 8.5 g/dL, white blood cells (WBC) \< 3,000/mm\^3, Platelets \< 100,000/mm\^3, Serum creatinine \> 2 times upper limit of normal (ULN), Serum alanine transaminase or aspartate aminotransferase \> 2 times ULN.
20 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Goshogawara-Shi, Aomori, Japan
Local Institution
Chiba, Chiba, Japan
Local Institution
Fukui-shi, Fukui, Japan
Local Institution
Fukui-shi, Fukui, Japan
Local Institution
Fukui-shi, Fukui, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Kitakyushu-Shi, Fukuoka, Japan
Local Institution
Higashi-Hiroshima-Shi, Hiroshima, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Kanzaki-Gun, Hyōgo, Japan
Local Institution
Kato-Gun, Hyōgo, Japan
Local Institution
Hitachi-Shi, Ibaraki, Japan
Local Institution
Tsukuba, Ibaraki, Japan
Local Institution
Sagamihara-Shi, Kanagawa, Japan
Local Institution
Sendai, Miyagi, Japan
Local Institution
Sendai, Miyagi, Japan
Local Institution
Sendai, Miyagi, Japan
Local Institution
Nagano, Nagano, Japan
Local Institution
Tsukubo-Gun, Okayama-ken, Japan
Local Institution
Kawachinagano-Shi, Osaka, Japan
Local Institution
Ureshino-Shi, Saga-ken, Japan
Local Institution
Iruma-Gun, Saitama, Japan
Local Institution
Kawagoe-Shi, Saitama, Japan
Local Institution
Kitamoto-Shi, Saitama, Japan
Local Institution
Hamamatsu, Shizuoka, Japan
Local Institution
Kawachigun, Tochigi, Japan
Local Institution
Shimotsuke-Shi, Tochigi, Japan
Local Institution
Arakawa-Ku, Tokyo, Japan
Local Institution
Bunkyo-Ku, Tokyo, Japan
Local Institution
Bunkyo-Ku, Tokyo, Japan
Local Institution
Setagaya-Ku, Tokyo, Japan
Local Institution
Shinjuku-Ku, Tokyo, Japan
Local Institution
Takaoka-Shi, Toyama, Japan
Local Institution
Chiba, , Japan
Countries
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References
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Takeuchi T, Matsubara T, Urata Y, Suematsu E, Ohta S, Honjo S, Abe T, Yamamoto A, Miyasaka N; Japan Abatacept Study Group. Phase III, multicenter, open-label, long-term study of the safety of abatacept in Japanese patients with rheumatoid arthritis and an inadequate response to conventional or biologic disease-modifying antirheumatic drugs. Mod Rheumatol. 2014 Sep;24(5):744-53. doi: 10.3109/14397595.2014.899179. Epub 2014 Apr 23.
Related Links
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Investigator Inquiry form
Other Identifiers
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IM101-129
Identifier Type: -
Identifier Source: org_study_id
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