The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
405
American College of Rheumatology (ACR) 20% response rate
Time frame: 4 months (week 16)
Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)
Time frame: Baseline (Day 1), 6 months (Week 24)
Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)
Time frame: Baseline (Day 1), 4 months (Week 16)
Non-progressors rate for the structural damage
The non-progressors rate is defined as the proportion of subjects meeting the change from baseline in the TSS at 6 months less than or equal to the smallest detectable difference (SDD) and/or the smallest detectable change (SDC)
Time frame: Baseline (Day 1), 6 months (Week 24)
ACR 50 response rates
Time frame: 4 months (Week16)
ACR 70 response rates
Time frame: 4 months (Week16)
Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities
Time frame: 12 months (Week52)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Kamogawa, Chiba, Japan
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Kasamatsu-town, Gifu, Japan
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Kakogawa, Hyōgo, Japan
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Yokohama, Kanagawa, Japan
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Kurashiki, Okayama-ken, Japan
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Izumisano, Osaka, Japan
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Fujieda, Shizuoka, Japan
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Toyama, Toyama, Japan
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Shimonoseki, Yamaguchi, Japan
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Asahi, Japan
...and 64 more locations