An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant Methotrexate

Number of Patients With Adverse Events as a Measure of Safety Per Treatment Group in Period I

时间窗: Period I: from Week 0 up until Week 30;

Period I: Patients were carefully monitor for Adverse Events from signing of informed consent until week 30 and thereafter during Period II of the study. For patients who discontinued early, a follow-up period of 4 weeks was added to the Early Termination Visit. The investigator actively asked the patients for Adverse Events. Patients spontaneously reported Adverse Events to the Investigator during clinic visits or in between visits.

Number of Patients With Adverse Events as a Measure of Safety in Period II - Single Treatment Period

时间窗: Period II: from Week 30 up to Week 80

From week 30 all subjects were transferred to receive FKB327 treatment. Adverse Events were contentiously monitored and recorded during Period II. For patients discontinuing the study prematurely, a follow-up period of 4 weeks was added to the Early Termination Visit. The data for Period II is based on the number of patients in the Safety Analysis Set that entered Period II.

Number of Patients With Serious Adverse Events as a Measure of Safety Per Treatment Group in Period I

时间窗: Period I: from Week 0 up until Week 30

A Serious Adverse Event (SAE) was defined in the Protocol as: Death; or a Life-threatening Adverse Event (AE); Inpatient Hospitalization; Persistant or significant disability or incapacity; A congenital anomaly/birth defect; An important medical event that may not have resulted in death, have been life-threatening, or required hospitalization, but may have jeopardized the patient and may have required medical intervention to prevent 1 of the outcomes listed in this definition. SAEs were followed until resolution, the investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.

Number of Patients With Serious Adverse Events as a Measure of Safety in Period II - Single Treatment Period

时间窗: Period II: from Week 30 up to Week 80

Period II: at week 30 all patients were transferred to receive FKB327. Each subject was counted once within each System Organ Class (SOC) and Preferred Term (PT). Death defined as a fatal outcome of a (S)AE. SAEs were followed until resolution, the investigator confirmed the event was unlikely to resolve or the patient was lost to follow-up.

Changes in Vital Signs as a Measure of Safety - Systolic Blood Pressure

时间窗: From Week 0 to Week 80

Systolic Blood Pressure is part of Vital Signs which were part of the subject safety evaluations. Systolic Blood Pressure was measured at the following time-points: Week 0, Week 4, Week 8, Week 12, Week 24 and Week 80/End o Study (EOS). Systolic Blood Pressure with changes from Baseline_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit. Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002.

Changes in Vital Signs as a Measure of Safety - Diastolic Blood Pressure

时间窗: From Week 0 to Week 80

Diastolic Blood Pressure is part of Vital Signs which were part of the subject safety evaluations. Diastolic Blood Pressure was measured at the following time-points: Week 0, Week 4, Week 8, Week 12, Week 24 and Week 80/End o Study (EOS). Diastolic Blood Pressure with changes from Baseline_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit measured. Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002.

Changes in Vital Signs as a Measure of Safety - Pulse Rate

时间窗: From Week 0 to Week 80

Pulse rate is part of Vital Signs which were part of the subject safety evaluations. Pulse rate was measured at the following time-points: Weeks 0, 4, 8, 12, 24 and 80/End of Study (EOS). Pulse Rate with changes from Baseline_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit. Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002.

Changes in Vital Signs as a Measure of Safety - Temperature Measurements

时间窗: From Week 0 to Week 80

Temperature measurements forms part of the vital signs which was one of the continuous safety measurements for the study primary endpoint. Temperature was measured at week 0, week 4, week 8, week 12, week 24 and at week 80 or at End of Study (EOS). Temperature with change from Baseline_002 were summarized by treatment sequence over the whole study period. Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administration at Week 0 from Study FKB327-002 (NCT02260791).

Summary of Most Common Clinical Significant Laboratory Parameters Reported as Adverse Events (Reported by ≥1% of the Patients)

时间窗: From Week 0 to Week 80

Clinical Laboratory tests for hematology and serum chemistry were performed by the sites and analysed at a Central Laboratory. Urine dip-stick tests were performed by the sites. Laboratory samples were taken at the following time-points (weeks): 0; 4; 8; 12; 24; 30; 42; 54; 66; 76 and 80/End of Study (EOS). Each result outside its normal range was review and assessed by the investigator whether or not it was Clinically Significant (CS) or Not Clinically Significant (NCS) CS laboratory abnormalities were recorded as AEs.