The purpose of this study is to evaluate the safety and tolerability of multiple doses of LY2439821 in Japanese patients with rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, Japan
Number of Participants With Clinically Significant Effects
Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.
Time frame: Baseline up to 26 weeks
Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein
C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter.
Time frame: Baseline, 16 weeks
Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)
Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h).
Time frame: Baseline, 16 weeks
Change From Baseline to 26 Week Endpoint in Neutrophil Counts
Time frame: Baseline, 26 weeks
Change From Baseline to 26 Week Endpoint in Lymphocyte Counts
Time frame: Baseline, 26 weeks
Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)
AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss)
Time frame: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss)
Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss)
Time frame: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hyōgo, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ibaraki, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nagasaki, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Niigata, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Okayama, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shimane, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, Japan
Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss)
tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss)
Time frame: Week 10 pre-dose up to 2 weeks post-dose (Week 12)