Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan
NCT ID: NCT00688103
Last Updated: 2015-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
151 participants
INTERVENTIONAL
2005-06-30
2010-10-31
Brief Summary
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1. Etanercept alone treatment group (25mg, twice/week, s.c.)
2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ETN Alone
etanercept (25mg, twice/week, s.c.)
ETN Alone
etanercept (25 mg, twice/week, s.c.)
ETN+MTX
etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)
ETN+MTX
etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)
Interventions
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ETN Alone
etanercept (25 mg, twice/week, s.c.)
ETN+MTX
etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* fulfilled the 1987 revised classification criteria for RA by in American College of Rheumatology (ACR)
* met the guidelines for the proper use of ETN in Japan (having at least 6 tender joints and 6 swollen joints
* either serum C-reactive protein more than 2 mg/dl or ESR no less than 28 mm at 1 hour, with adequate safety profiles)
* be ACR functional class I-III
* have been receiving MTX 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment
Exclusion Criteria
* the start of dose increment of PSL equivalents within 3 months of the study enrollment
* experience of antirheumatic therapy except for MTX and PSL equivalents
* previous treatment with ETN or any other biological treatment
18 Years
ALL
No
Sponsors
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Japan Biological Agent Study Integrated Consortium
NETWORK
Responsible Party
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Hideto Kameda
Professor, Toho University
Principal Investigators
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Tsutomu Takeuchi, MD, PhD
Role: STUDY_CHAIR
JBASIC
Locations
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Keio University
Tokyo, Tokyo, Japan
Countries
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References
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Kameda H, Ueki Y, Saito K, Nagaoka S, Hidaka T, Atsumi T, Tsukano M, Kasama T, Shiozawa S, Tanaka Y, Takeuchi T; Japan Biological Agent Study Integrated Consortium. Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy: a randomized trial. Mod Rheumatol. 2010 Dec;20(6):531-8. doi: 10.1007/s10165-010-0324-4. Epub 2010 Jun 24.
Kameda H, Kanbe K, Sato E, Ueki Y, Saito K, Nagaoka S, Hidaka T, Atsumi T, Tsukano M, Kasama T, Shiozawa S, Tanaka Y, Yamanaka H, Takeuchi T. Continuation of methotrexate resulted in better clinical and radiographic outcomes than discontinuation upon starting etanercept in patients with rheumatoid arthritis: 52-week results from the JESMR study. J Rheumatol. 2011 Aug;38(8):1585-92. doi: 10.3899/jrheum.110014. Epub 2011 May 15.
Kameda H, Kanbe K, Sato E, Ueki Y, Saito K, Nagaoka S, Hidaka T, Atsumi T, Tsukano M, Kasama T, Shiozawa S, Tanaka Y, Yamanaka H, Takeuchi T; Japan Biological Agent Integrated Consortium (JBASIC). A merged presentation of clinical and radiographic data using probability plots in a clinical trial, the JESMR study. Ann Rheum Dis. 2013 Feb;72(2):310-2. doi: 10.1136/annrheumdis-2012-201804. Epub 2012 Sep 12. No abstract available.
Other Identifiers
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Etanercept-01
Identifier Type: -
Identifier Source: org_study_id
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