The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks, compared with placebo, in patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD) therapy.
This is a randomized (treatment assigned by chance, like flipping a coin), multicenter, double-blind (neither physician nor patient will know the treatment the patient receives), parallel-group (each group of patients will be treated at the same time) study. JNJ-40346527 will be compared to a placebo, which is an inactive substance used to test whether a drug has a real effect. Patients will receive study medication for 12 weeks and will continue their permitted, stable DMARD therapy (methotrexate \[MTX\], sulfasalazine \[SSZ\], and/or hydroxychloroquine \[HCQ\]) through Week 12. A follow-up visit will occur 4 weeks after dosing is complete. The maximum length of patient participation will be 22 weeks, including a 6-week screening period. Other study visits will occur during the study, and patient safety will be monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Type=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily.
Form=capsule; route=oral use; twice daily.
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Buenos Aires, Argentina
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San Juan, Argentina
Change from baseline in the Disease Activity Score (DAS28), using C-reactive protein (CRP)
The DAS28 is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and an overall assessment of disease activity.
Time frame: Week 12
ACR 20 response
ACR 20 (American College of Rheumatology) response is a 20% improvement in rheumatoid arthritis (RA) symptoms.
Time frame: Week 12
DAS28 (using CRP) response
DAS28 response is the improvement from baseline and is rated as "No response," Moderate response," or "Good response."
Time frame: Week 12
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San Miguel de Tucumán, Argentina
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Plovdiv, Bulgaria
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Sevlievo, Bulgaria
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Veliko Tarnovo, Bulgaria
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Providencia, Chile
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Santiago, Chile
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Prague, Czechia
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Slaný, Czechia
...and 22 more locations