TL011 in Severe, Active Rheumatoid Arthritis Patients

Maximum Observed Concentration (Cmax) in Part B

Time frame: Day 1 to Day 57

Number of Participants With Adverse Events in Part B

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as AEs occurring after the first dose of the study drug until 120 days after the last dose of study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Time frame: From randomization up to Week 24

Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B

Time frame: Day 1, Day 15

AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B

Time frame: Day 1, Day 15

Percent Change From Baseline in CD19+ B-cell Count in Part B

Time frame: Baseline to Day 57

Number of Participants With American College of Rheumatology (ACR20) Criteria Response in Part B

Defined as at least 20% improvement from the screening values in swollen and tender joint count and in 3 of the following 5 disease activity measures. * Physician's global assessment of disease activity (VAS) * Patient's assessment of RA pain (VAS) * Patient's global assessment of disease activity * Patient's assessment of physical function (Health Assessment Questionnaire) * Acute phase reactant (C-reactive protein \[CRP\])