This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients with active RA. The study will also evaluate the safety and tolerability of VX-509 compared to placebo when administered for 12 weeks to subjects with active RA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
206
Proportion of subjects who achieve an ACR20 response
Time frame: Week 12
Change from baseline in DAS28
Time frame: Week 12
Proportion of subjects who achieve an ACR50,70 response
Time frame: Week 12
Proportion of subjects who achieve moderate or good EULAR response
Time frame: Week 12
Magnitude of improvement in the components of the ACR response criteria
Time frame: Week 12
Pharmacokinetics of VX-509
Time frame: Week 6
Pharmacodynamics (PD) of biomarker responses
Time frame: Week 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
tablet, 100 mg b.i.d. for 12 weeks
tablet, 150 mg b.i.d. for 12 weeks
Unnamed facility
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Peoria, Arizona, United States
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La Mesa, California, United States
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Trumbull, Connecticut, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Venice, Florida, United States
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Decatur, Georgia, United States
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Worcester, Massachusetts, United States
...and 38 more locations