This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
673
7.5-20mg po weekly
8mg/kg iv every 4 weeks
Percentage of patients with ACR 20 response
Time frame: Week 24
Percentage of patients with ACR 20 response
Time frame: Week 8
Percentage of patients with ACR 50 and ACR 70 responses
Time frame: Week 24
Mean change in parameters of ACR core set
Time frame: Week 24
AEs, laboratory parameters, vital signs.
Time frame: Throughout study
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Montgomery, Alabama, United States
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Mesa, Arizona, United States
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Paradise Valley, Arizona, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Huntington Beach, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Palm Springs, California, United States
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Sacramento, California, United States
...and 137 more locations