This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate.
VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the treatment of RA, and a broad range of other autoimmune diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
359
50 mg oral tablet
0 mg oral tablet
Proportion of subjects who achieve a 20% improvement in disease severity according to the American College of Rheumatology criteria, assessed using the C-reactive protein level (ACR20-CRP) response
Time frame: Week 12
Change from baseline in Disease Activity Score 28 using C-reactive protein (DAS28- CRP)
Time frame: Week 12
Safety and tolerability
Measured by incidence of treatment-emergent adverse events
Time frame: Week 12
Safety and tolerability
Measured by clinical laboratory values (serum chemistry, hematology, coagulation studies, and urinalysis)
Time frame: Week 12
Safety and tolerability
Measured by 12-lead ECG outcomes
Time frame: Week 12
Safety and tolerability
Measured by vital signs
Time frame: Week 12
Proportion of subjects who achieve an ACR20-CRP response
Time frame: Week 24
Proportion of subjects who achieve ACR50-CRP and ACR70-CRP responses
Time frame: Week 12 and 24
Proportion of subjects who achieve a moderate or good response according to the European League Against Rheumatism (EULAR) response criteria
Time frame: Week 12 and 24
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Vertex Investigational Site
Birmingham, Alabama, United States
Vertex Investigational Site
Huntsville, Alabama, United States
Vertex Investigational Site
Long Beach, California, United States
Vertex Investigational Site
Tustin, California, United States
Vertex Investigational Site
Boca Raton, Florida, United States
Vertex Investigational Site
Daytona Beach, Florida, United States
Vertex Investigational Site
New Port Richey, Florida, United States
Vertex Investigational Site
North Miami Beach, Florida, United States
Vertex Investigational Site
Ocala, Florida, United States
Vertex Investigational Site
Tampa, Florida, United States
...and 84 more locations
Proportion of subjects who achieve remission as defined by DAS28-CRP response
Time frame: Week 12 and 24
Proportion of subjects who achieve remission as defined by the ACR/EULAR definition of remission
Time frame: Week 12 and 24
Change from baseline in selected Patient Reported Outcomes (PROs)
Time frame: Week 12 and 24
Change from baseline in DAS28- CRP
Time frame: Week 24
Safety and tolerability as indicated by adverse events, hematology, clinical chemistry, coagulation, urinalysis, electrocardiograms (ECGs) and vital signs
Time frame: Week 24