This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. 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
1,220
iv every 4 weeks
8mg/kg iv every 4 weeks
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Paradise Valley, Arizona, United States
Unnamed facility
Peoria, Arizona, United States
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Percentage of patients with ACR 20 response
Time frame: Week 24
Percentage of patients with ACR 50 and ACR 70 responses.
Time frame: Week 24
Mean changes in parameters of ACR core set
Time frame: Week 24
AEs, laboratory parameters, vital signs.
Time frame: Throughout study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Little Rock, Arkansas, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Palm Desert, California, United States
Unnamed facility
Palo Alto, California, United States
Unnamed facility
San Jose, California, United States
...and 136 more locations