The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
119
Placebo solution for injection, administered as subcutaneous injections
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
102
Chiba, Japan
Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12
Time frame: From Week 0 (Baseline) to Week 12
Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
Number of subjects who achieve ACR 20 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.
Time frame: From Week 0 (Baseline) to Week 12
Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12
Number of subjects who achieve ACR 50 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.
Time frame: From Week 0 (Baseline) to Week 12
Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12
Number of subjects who achieve ACR 70 will be calculated at week 12. The calculations is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.
Time frame: From Week 0 (Baseline) to Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Olokizumab 240 mg solution for injection, administered as subcutaneous injections
114
Fukuoka, Japan
115
Fukuoka, Japan
113
Hiroshima, Japan
120
Kakogawa, Japan
118
Kumamoto, Japan
116
Kurume, Japan
121
Matsuyama, Japan
122
Matsuyama, Japan
107
Nagaoka, Japan
...and 29 more locations