Trial Outcomes & Findings for PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis (NCT NCT02819726)

NCT ID: NCT02819726

Last Updated: 2020-02-17

Results Overview

Pharmacokinetic endpoint: Area under the concentration-time curve from time 0 (immediately predose on Day 1) to last quantifiable concentration (AUC0-t). Geometric means by treatment (Pharmacokinetic Analysis Set).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 294 participants
• Primary outcome timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.
• Results posted on: 2020-02-17

Participant Flow

This was a global study conducted in 66 study centres. The first participant entered the study on 11 October 2016 and the date of the last participants last study visit was 07 November 2018.

Participant milestones

Measure	SAIT101 (Part A and B) 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera (Part A and B) 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan (Part A and B) 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants	SAIT101 (Part B Only) 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,
Part A (All Participants) STARTED	98	98	98	0
Part A (All Participants) COMPLETED	92	88	87	0
Part A (All Participants) NOT COMPLETED	6	10	11	0
Part B (All Participants) STARTED	73	70	39	38
Part B (All Participants) COMPLETED	70	68	35	36
Part B (All Participants) NOT COMPLETED	3	2	4	2

Reasons for withdrawal

Measure	SAIT101 (Part A and B) 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera (Part A and B) 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan (Part A and B) 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants	SAIT101 (Part B Only) 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,
Part A (All Participants) Lost to Follow-up	0	1	0	0
Part A (All Participants) Withdrawal by Subject	3	5	6	0
Part A (All Participants) Protocol non-compliance	3	4	5	0
Part B (All Participants) Lost to Follow-up	1	1	2	2
Part B (All Participants) Withdrawal by Subject	2	1	1	0
Part B (All Participants) Protocol non-compliance	0	0	1	0

Baseline Characteristics

Results were not available for 1 participant in each treatment arm

Baseline characteristics by cohort

Measure	SAIT101 n=98 Participants SAIT101: 1,000 mg i.v. of SAIT101 on Day 1 and 15. 1,000 mg i.v. of SAIT101 on week 24 and 26 for eligible participants.	MabThera n=98 Participants MabThera: 1,000 mg i.v. of MabThera® on Day 1 and 15. 1,000 mg i.v. of MabThera® on week 24 and 26 for eligible participants.	Rituxan n=98 Participants Rituxan: 1,000 mg i.v. of Rituxan® on Day 1 and 15. 1,000 mg i.v. of Rituxan® on week 24 and 26 for eligible participants.	Total n=294 Participants Total of all reporting groups
Age, Continuous	50.9 years STANDARD_DEVIATION 12.41 • n=98 Participants	52.5 years STANDARD_DEVIATION 10.87 • n=98 Participants	52.1 years STANDARD_DEVIATION 12.09 • n=98 Participants	51.8 years STANDARD_DEVIATION 11.79 • n=294 Participants
Age, Customized 18-60 years	76 Participants n=98 Participants	75 Participants n=98 Participants	71 Participants n=98 Participants	222 Participants n=294 Participants
Age, Customized >60 years	22 Participants n=98 Participants	23 Participants n=98 Participants	27 Participants n=98 Participants	72 Participants n=294 Participants
Sex: Female, Male Female	79 Participants n=98 Participants	81 Participants n=98 Participants	80 Participants n=98 Participants	240 Participants n=294 Participants
Sex: Female, Male Male	19 Participants n=98 Participants	17 Participants n=98 Participants	18 Participants n=98 Participants	54 Participants n=294 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=98 Participants	30 Participants n=98 Participants	29 Participants n=98 Participants	89 Participants n=294 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=98 Participants	68 Participants n=98 Participants	69 Participants n=98 Participants	205 Participants n=294 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=98 Participants	0 Participants n=98 Participants	0 Participants n=98 Participants	0 Participants n=294 Participants
Race (NIH/OMB) American Indian or Alaska Native	24 Participants n=98 Participants	20 Participants n=98 Participants	21 Participants n=98 Participants	65 Participants n=294 Participants
Race (NIH/OMB) Asian	18 Participants n=98 Participants	19 Participants n=98 Participants	24 Participants n=98 Participants	61 Participants n=294 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=98 Participants	0 Participants n=98 Participants	0 Participants n=98 Participants	0 Participants n=294 Participants
Race (NIH/OMB) Black or African American	2 Participants n=98 Participants	0 Participants n=98 Participants	1 Participants n=98 Participants	3 Participants n=294 Participants
Race (NIH/OMB) White	52 Participants n=98 Participants	56 Participants n=98 Participants	52 Participants n=98 Participants	160 Participants n=294 Participants
Race (NIH/OMB) More than one race	2 Participants n=98 Participants	3 Participants n=98 Participants	0 Participants n=98 Participants	5 Participants n=294 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=98 Participants	0 Participants n=98 Participants	0 Participants n=98 Participants	0 Participants n=294 Participants
Region of Enrollment South Korea	5 participants n=98 Participants	3 participants n=98 Participants	6 participants n=98 Participants	14 participants n=294 Participants
Region of Enrollment Hungary	3 participants n=98 Participants	0 participants n=98 Participants	4 participants n=98 Participants	7 participants n=294 Participants
Region of Enrollment Czechia	7 participants n=98 Participants	3 participants n=98 Participants	2 participants n=98 Participants	12 participants n=294 Participants
Region of Enrollment United States	9 participants n=98 Participants	13 participants n=98 Participants	6 participants n=98 Participants	28 participants n=294 Participants
Region of Enrollment Poland	15 participants n=98 Participants	19 participants n=98 Participants	23 participants n=98 Participants	57 participants n=294 Participants
Region of Enrollment Mexico	27 participants n=98 Participants	21 participants n=98 Participants	21 participants n=98 Participants	69 participants n=294 Participants
Region of Enrollment Bulgaria	4 participants n=98 Participants	5 participants n=98 Participants	4 participants n=98 Participants	13 participants n=294 Participants
Region of Enrollment Bosnia and Herzegovina	4 participants n=98 Participants	3 participants n=98 Participants	1 participants n=98 Participants	7 participants n=294 Participants
Region of Enrollment Germany	2 participants n=98 Participants	3 participants n=98 Participants	2 participants n=98 Participants	8 participants n=294 Participants
Region of Enrollment India	13 participants n=98 Participants	16 participants n=98 Participants	17 participants n=98 Participants	46 participants n=294 Participants
Region of Enrollment Spain	9 participants n=98 Participants	12 participants n=98 Participants	12 participants n=98 Participants	33 participants n=294 Participants
Disease duration	9.8 years STANDARD_DEVIATION 6.73 • n=98 Participants	11.2 years STANDARD_DEVIATION 7.72 • n=98 Participants	9.3 years STANDARD_DEVIATION 7.10 • n=98 Participants	10.1 years STANDARD_DEVIATION 7.22 • n=294 Participants
C-reactive protein	19.5 mg/L STANDARD_DEVIATION 28.99 • n=98 Participants	15.3 mg/L STANDARD_DEVIATION 20.63 • n=98 Participants	16.2 mg/L STANDARD_DEVIATION 17.91 • n=98 Participants	17.0 mg/L STANDARD_DEVIATION 2.99 • n=294 Participants
Erythrocyte sedimentation rate	51.0 mm/hr STANDARD_DEVIATION 26.58 • n=97 Participants • Results were not available for 1 participant in each treatment arm	47.5 mm/hr STANDARD_DEVIATION 22.87 • n=97 Participants • Results were not available for 1 participant in each treatment arm	51.5 mm/hr STANDARD_DEVIATION 23.35 • n=97 Participants • Results were not available for 1 participant in each treatment arm	50.0 mm/hr STANDARD_DEVIATION 24.31 • n=291 Participants • Results were not available for 1 participant in each treatment arm
Swollen Joint Count (SJC66)	15.2 Joints STANDARD_DEVIATION 7.97 • n=98 Participants • Results were not available for 1 participant in the MabThera treatment arm	15.2 Joints STANDARD_DEVIATION 7.01 • n=97 Participants • Results were not available for 1 participant in the MabThera treatment arm	13.0 Joints STANDARD_DEVIATION 6.19 • n=98 Participants • Results were not available for 1 participant in the MabThera treatment arm	14.5 Joints STANDARD_DEVIATION 7.14 • n=293 Participants • Results were not available for 1 participant in the MabThera treatment arm
Tender Joint Count (TJC68)	21.7 Joints STANDARD_DEVIATION 11.08 • n=98 Participants • Results were not available for 1 participant in the MabThera treatment arm	22.6 Joints STANDARD_DEVIATION 13.66 • n=97 Participants • Results were not available for 1 participant in the MabThera treatment arm	20.0 Joints STANDARD_DEVIATION 10.84 • n=98 Participants • Results were not available for 1 participant in the MabThera treatment arm	21.4 Joints STANDARD_DEVIATION 11.93 • n=293 Participants • Results were not available for 1 participant in the MabThera treatment arm
Patient Global Assessments Visual Analogue Scale (VAS) Score	68.9 units on a scale STANDARD_DEVIATION 15.87 • n=97 Participants • Results were not available for 1 participant in each treatment arm	67.6 units on a scale STANDARD_DEVIATION 17.53 • n=97 Participants • Results were not available for 1 participant in each treatment arm	70.8 units on a scale STANDARD_DEVIATION 17.04 • n=97 Participants • Results were not available for 1 participant in each treatment arm	69.1 units on a scale STANDARD_DEVIATION 16.82 • n=291 Participants • Results were not available for 1 participant in each treatment arm
Physician Global Assessment VAS Score	71.0 units on a scale STANDARD_DEVIATION 14.3 • n=97 Participants • Results were not available for 1 participant in the SAIT101 treatment arm and 1 participant in the MabThera treatment arm	69.4 units on a scale STANDARD_DEVIATION 15.9 • n=97 Participants • Results were not available for 1 participant in the SAIT101 treatment arm and 1 participant in the MabThera treatment arm	69.8 units on a scale STANDARD_DEVIATION 14.32 • n=98 Participants • Results were not available for 1 participant in the SAIT101 treatment arm and 1 participant in the MabThera treatment arm	70.1 units on a scale STANDARD_DEVIATION 14.51 • n=292 Participants • Results were not available for 1 participant in the SAIT101 treatment arm and 1 participant in the MabThera treatment arm
Patient Pain Assessment VAS Score	67.0 units on a scale STANDARD_DEVIATION 18.71 • n=98 Participants • Results were not available for 1 participant in the Rituxan treatment arm	68.8 units on a scale STANDARD_DEVIATION 20.02 • n=98 Participants • Results were not available for 1 participant in the Rituxan treatment arm	70.7 units on a scale STANDARD_DEVIATION 19.06 • n=97 Participants • Results were not available for 1 participant in the Rituxan treatment arm	68.8 units on a scale STANDARD_DEVIATION 19.27 • n=293 Participants • Results were not available for 1 participant in the Rituxan treatment arm
Health Assessment Questionnaire Disability Index (HAQ-DI) Score	1.7 Score STANDARD_DEVIATION 0.57 • n=98 Participants • Results were not available for 1 participant in the Rituxan treatment arm	1.7 Score STANDARD_DEVIATION 0.64 • n=98 Participants • Results were not available for 1 participant in the Rituxan treatment arm	1.6 Score STANDARD_DEVIATION 0.64 • n=97 Participants • Results were not available for 1 participant in the Rituxan treatment arm	1.7 Score STANDARD_DEVIATION 0.62 • n=293 Participants • Results were not available for 1 participant in the Rituxan treatment arm
Disease activity score based on a 28-joint count-C-Reactive Protein (DAS-28-CRP(	5.28 units on a scale STANDARD_DEVIATION 0.890 • n=98 Participants • Results were not available for 1 participant in the MabThera treatment arm	5.29 units on a scale STANDARD_DEVIATION 0.807 • n=97 Participants • Results were not available for 1 participant in the MabThera treatment arm	5.17 units on a scale STANDARD_DEVIATION 0833 • n=98 Participants • Results were not available for 1 participant in the MabThera treatment arm	5.25 units on a scale STANDARD_DEVIATION 0.843 • n=293 Participants • Results were not available for 1 participant in the MabThera treatment arm
Disease activity score based on a 28-joint count - Erythrocyte sedimentation Rate (DAS28-ESR)	6.54 units on a scale STANDARD_DEVIATION 0.844 • n=96 Participants • Results were not available for 2 participants in each treatment arm	6.53 units on a scale STANDARD_DEVIATION 0.781 • n=96 Participants • Results were not available for 2 participants in each treatment arm	6.48 units on a scale STANDARD_DEVIATION 0.758 • n=96 Participants • Results were not available for 2 participants in each treatment arm	6.52 units on a scale STANDARD_DEVIATION 0.793 • n=288 Participants • Results were not available for 2 participants in each treatment arm
Anti-drug Antibody (ADA) Status Positive	2 Participants n=98 Participants • Results were not available for 2 participants in the Rituxan arm	1 Participants n=98 Participants • Results were not available for 2 participants in the Rituxan arm	4 Participants n=96 Participants • Results were not available for 2 participants in the Rituxan arm	7 Participants n=292 Participants • Results were not available for 2 participants in the Rituxan arm
Height	162.6 cm STANDARD_DEVIATION 9.29 • n=98 Participants • Results were not available for 1 participant in the Rituxan treatment arm	161.3 cm STANDARD_DEVIATION 8.79 • n=98 Participants • Results were not available for 1 participant in the Rituxan treatment arm	163.3 cm STANDARD_DEVIATION 8.37 • n=97 Participants • Results were not available for 1 participant in the Rituxan treatment arm	162.4 cm STANDARD_DEVIATION 8.83 • n=293 Participants • Results were not available for 1 participant in the Rituxan treatment arm
Weight	73.0 kg STANDARD_DEVIATION 17.62 • n=98 Participants	71.9 kg STANDARD_DEVIATION 16.94 • n=98 Participants	71.6 kg STANDARD_DEVIATION 17.99 • n=98 Participants	72.2 kg STANDARD_DEVIATION 17.47 • n=294 Participants
Body Mass Index (BMI)	27.5 Kg/m^2 STANDARD_DEVIATION 5.48 • n=98 Participants • Results were not available for 1 participant in the Rituxan treatment arm	27.5 Kg/m^2 STANDARD_DEVIATION 5.46 • n=98 Participants • Results were not available for 1 participant in the Rituxan treatment arm	26.7 Kg/m^2 STANDARD_DEVIATION 5.95 • n=97 Participants • Results were not available for 1 participant in the Rituxan treatment arm	27.2 Kg/m^2 STANDARD_DEVIATION 5.63 • n=293 Participants • Results were not available for 1 participant in the Rituxan treatment arm

PRIMARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. (AUC(0-t) could not be determined for 15 participants in the SAIT101 arm, 23 participants in the MabThera arm and 17 in the Rituxan arm as the Week 24 sample was either collected post-dose (i.e. not evaluable), was out of the collection window or was missing.

Pharmacokinetic endpoint: Area under the concentration-time curve from time 0 (immediately predose on Day 1) to last quantifiable concentration (AUC0-t). Geometric means by treatment (Pharmacokinetic Analysis Set).

Outcome measures

Measure	SAIT101 n=79 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=70 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=76 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Area Under the Concentration Time Cure From Time 0 to Last Quantifiable Concentration (AUC0-t)	144500 h*µg/mL Geometric Coefficient of Variation 34.2	151600 h*µg/mL Geometric Coefficient of Variation 33.2	154600 h*µg/mL Geometric Coefficient of Variation 35.6

PRIMARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. AUC0-∞ could not be calculated for 1 participant in the SAIT101 arm, 2 participants in the MabThera arm and 2 participants in the Rituxan arm as either the terminal phase was undetermined, the samples were missing or the Regulatory Scientific Quality (RSQ) was \<0.800.

Pharmacokinetic endpoint: Area Under the Plasma Concentration from time 0 to infinity (AUC0-∞ (infinity). Calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the elimination rate constant: AUC(0-last) + C(last)/λz.

Outcome measures

Measure	SAIT101 n=93 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=91 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=91 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Area Under the Plasma Concentration Versus Time Curve (AUC0-∞)	152300 h*µg/mL Geometric Coefficient of Variation 34.6	161900 h*µg/mL Geometric Coefficient of Variation 32.2	161300 h*µg/mL Geometric Coefficient of Variation 33.3

PRIMARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. AUC0-D15 could not be determined for 3 participants in the SAIT101 arm, 5 participants in the MabThera arm and 10 participants in the Rituxan arm as either the 336-hours blood sample was collected \<312 hours or samples were missing.

Pharmacokinetic endpoint: Area Under the Concentration verses time from time 0 to Day 15 prior to infusion (AUC0-D15) calculated by linear up/log down trapezoidal summation. Actual time/concentration on Day 15 was used for the calculation of this parameter unless the parameter was derived by interpolation.

Outcome measures

Measure	SAIT101 n=91 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=88 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=83 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Area Under the Plasma Concentration Versus Time Curve (AUC0-D15)	42950 h*µg/mL Geometric Coefficient of Variation 26.7	44600 h*µg/mL Geometric Coefficient of Variation 25.6	43540 h*µg/mL Geometric Coefficient of Variation 24.1

PRIMARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1 and 2 (Pre-dose 2). Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set.

Pharmacokinetic endpoint: Maximum Plasma Concentration (Cmax) after Day 15 infusion (Dose 2)

Outcome measures

Measure	SAIT101 n=94 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=93 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=93 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Peak Plasma Concentration (Cmax) After Day 15 Infusion	406.0 µg/mL Geometric Coefficient of Variation 28.3	427.7 µg/mL Geometric Coefficient of Variation 28.3	411.1 µg/mL Geometric Coefficient of Variation 24.5

PRIMARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1 and 2 (Pre-dose 2). Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. Ctrough could not be determined for 11 participants in the SAIT101 arm, 12 participants in the MabThera arm and 16 participants in the Rituxan arm as samples were collected outside of a 312 to 360 hour window.

Pharmacokinetic endpoint: Trough concentration (Ctrough) before the second infusion on Day 15 (Dose 2). Trough (pre-dose) concentration prior to second infusion on Day 15 obtained directly from the observed concentration versus time data.

Outcome measures

Measure	SAIT101 n=83 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=81 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=77 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Trough Concentration (Ctrough) Before the Second Infusion on Day 15	60.35 µg/mL Geometric Coefficient of Variation 40.3	67.75 µg/mL Geometric Coefficient of Variation 36.2	58.84 µg/mL Geometric Coefficient of Variation 97.9

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Full Analysis Set

Disease Activity Score 28 C-reactive protein score (DAS28-CRP) at Week 24 (Full Analysis Set). CRP samples were collected at Baseline and Weeks 8, 16 and 24. DAS28-CRP was calculated using the following equation: [0.56*Square Root (SQRT) (tender 28 joint count)+0.28*SQRT(swollen 28 joint count)+0.36*ln(CRP+1)]*1.10+1.15.

Total DAS28-CRP scores were calculates and range from 2.0 (minimum) to 10 (maximum). Lower scores represent a better patient outcome. Disease remission is considered achieved if the score is between 0 and <2.6. Low disease activity corresponds to 2.6 to <3.2. Moderate activity is between 3.2 & ≤5.1, while high activity is above 5.1.

Outcome measures

Measure	SAIT101 n=91 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=87 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=85 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Change From Baseline in DAS28-CRP at Week 24	-0.991 Score on a scale Standard Deviation 1.1735	-0.832 Score on a scale Standard Deviation 0.8483	-0.861 Score on a scale Standard Deviation 0.9488

SECONDARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. AUC0-w24 could not be determined for 30 participants in the SAIT101 arm, 32 participants in the MabThera arm and 28 participants either in the Rituxan arm as either there was no concentration at the start and/or end time, the Week 24 sample was out of window or samples were missing.

Pharmacokinetic endpoint: Area under the concentration time curve week 2 to week 24 (AUC(w2-24) calculated by linear up/log down trapezoidal summation.

Outcome measures

Measure	SAIT101 n=64 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=61 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=65 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Area Under the Concentration Time Curve Week 2 to Week 24 (AUC(w2-24)	107300 h*µg/mL Geometric Coefficient of Variation 41.1	109200 h*µg/mL Geometric Coefficient of Variation 40.0	116000 h*µg/mL Geometric Coefficient of Variation 40.2

SECONDARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8 and 12. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. AUC0-w12 could not be determined for 1 participant in the SAIT101 arm, 4 participants in the MabThera arm and 1 participant in the Rituxan arm because samples were missing

Pharmacokinetic endpoint: Area under the concentration time curve Day 0 to Week 12 calculated by linear up/log down trapezoidal summation.

Outcome measures

Measure	SAIT101 n=93 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=89 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=92 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Area Under the Concentration Time Curve Day 0 to Week 12 (AUC(0-w12))	148500 h*µg/mL Geometric Coefficient of Variation 33.1	157400 h*µg/mL Geometric Coefficient of Variation 30.3	155900 h*µg/mL Geometric Coefficient of Variation 33.1

SECONDARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. Tmax (dose 1) could not be determined for 1 participant in the SAIT101 arm, 1 patient in the MabThera arm and 2 participants in the Rituxan arm as samples were missing or set to missing due to initial or embedded Below the Limit of Quantification (BLQ)..

Pharmacokinetic endpoint: Maximum plasma concentration over the first dosing interval obtained directly from the observed concentration versus time data.

Outcome measures

Measure	SAIT101 n=93 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=92 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=91 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Time to Maximum Plasma Concentration (Tmax) (Dose 1)	5.167 Hours Interval 3.0 to 6.5	5.167 Hours Interval 3.0 to 358.75	4.500 Hours Interval 3.0 to 6.75

SECONDARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set

Time of maximum concentration postinfusion over the second dosing interval, obtained directly from the observed concentration versus time data.

Outcome measures

Measure	SAIT101 n=94 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=93 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=93 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Time to Maximum Plasma Concentration (Tmax) (Dose 2)	4.167 Hours Interval 2.92 to 5.5	4.167 Hours Interval 0.0 to 48.08	4.250 Hours Interval 2.92 to 23.5

SECONDARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. λz could not be determined for 1 participant in the SAIT101 arm, 2 participants in the MabThera arm and 1 participant in the Rituxan arm as either the terminal phase was undetermined or the Regulatory Scientific Quality (RSQ) was \<0.800.

Pharmacokinetic endpoint: Apparent terminal rate constant (λz) determined by linear regression of the terminal points of the log-linear concentration-time curve. Best fit method followed by visual assessment was used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points was used for determination.

Outcome measures

Measure	SAIT101 n=93 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=91 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=92 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Apparent Terminal Rate Constant (λz)	0.002358 1/hr Standard Deviation 0.00061132	0.002283 1/hr Standard Deviation 0.00067311	0.002240 1/hr Standard Deviation 0.00059435

SECONDARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. CL could not be determined for 1 participant in the SAIT101 arm, 2 participants in the MabThera arm and 2 participants in the Rituxan arm as either the terminal phase was undetermined or the Regulatory Scientific Quality (RSQ) was \<0.800.

Pharmacokinetic endpoint: Systemic clearance (CL) over the first dosing period calculated as dose (first + second dose) divided by AUC(0-∞).

Outcome measures

Measure	SAIT101 n=93 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=91 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=91 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Systemic Clearance (CL)	0.01314 L/day Geometric Coefficient of Variation 34.6	0.01235 L/day Geometric Coefficient of Variation 29.0	0.01240 L/day Geometric Coefficient of Variation 33.3

SECONDARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. VD could not be determined for 1 participant in the SAIT101 arm, 2 participants in the MabThera arm and 2 participants in the Rituxan arm as either the terminal phase was undetermined or the Regulatory Scientific Quality was \<0.800.

Pharmacokinetic endpoint: Volume of distribution (VD) over the first dosing period calculated as dose (first + second dose) divided by [λz AUC(0-∞)]

Outcome measures

Measure	SAIT101 n=93 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=91 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=91 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Volume of Distribution (VD)	5.757 Litres (L) Geometric Coefficient of Variation 28.0	5.635 Litres (L) Geometric Coefficient of Variation 23.6	5.727 Litres (L) Geometric Coefficient of Variation 22.9

SECONDARY outcome

Timeframe: Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic Analysis Set. T1/2 could not be determined for 1 participant in the SAIT101 arm, 2 participants in the MabThera arm and 1 participant in the Rituxan arm as either the terminal was undetermined or the Regulatory Scientific Quality was \<0.800.

Pharmacokinetic endpoint: Terminal half-life determined as ln2/λz.

Outcome measures

Measure	SAIT101 n=93 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=91 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=92 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Terminal Half-life (T1/2)	303.7 Hours Geometric Coefficient of Variation 26.1	316.1 Hours Geometric Coefficient of Variation 29.0	319.7 Hours Geometric Coefficient of Variation 26.2

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) samples taken at Baseline and Weeks 8, 16, 24, 36 and 52. DAS28-CRP was calculated using the following equation: [0.56*Square Root (SQRT) (tender 28 joint count)+0.28*SQRT(swollen 28 joint count)+0.36*ln(CRP+1)]*1.10+1.15.

Total DAS28-CRP scores are presented and range from 2.0 (minimum) to 10 (maximum). Lower scores represent a better patient outcome. Disease remission is considered achieved if the score is between 0 and <2.6. Low disease activity corresponds to 2.6 to <3.2. Moderate activity is between 3.2 & ≤5.1, while high activity is above 5.1.

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=97 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Change From Baseline in DAS28-CRP at Weeks 8, 16, 36 and 52 Day 1 (Baseline)	5.282 score on a scale Standard Deviation 0.8899	5.288 score on a scale Standard Deviation 0.8073	5.170 score on a scale Standard Deviation 0.8326
Change From Baseline in DAS28-CRP at Weeks 8, 16, 36 and 52 Week 8	4.405 score on a scale Standard Deviation 1.0189	4.324 score on a scale Standard Deviation 1.1132	4.251 score on a scale Standard Deviation 1.1392
Change From Baseline in DAS28-CRP at Weeks 8, 16, 36 and 52 Week 16	4.001 score on a scale Standard Deviation 1.1116	4.155 score on a scale Standard Deviation 0.9750	4.100 score on a scale Standard Deviation 1.0044
Change From Baseline in DAS28-CRP at Weeks 8, 16, 36 and 52 Week 24	4.300 score on a scale Standard Deviation 1.0331	4.463 score on a scale Standard Deviation 1.0648	4.443 score on a scale Standard Deviation 0.9774
Change From Baseline in DAS28-CRP at Weeks 8, 16, 36 and 52 Week 36	3.552 score on a scale Standard Deviation 1.1452	3.823 score on a scale Standard Deviation 0.9290	3.716 score on a scale Standard Deviation 1.0684
Change From Baseline in DAS28-CRP at Weeks 8, 16, 36 and 52 Week 52 (End of Study(	3.660 score on a scale Standard Deviation 1.2636	3.754 score on a scale Standard Deviation 1.3037	3.518 score on a scale Standard Deviation 1.1276

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

American Collage of Rheumatology (ACR) 20% response criteria (ACR20) response rates were assessed at Baseline and Weeks 8, 16, 24, 36 and 52.

An ACR20 response is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [Health Assessment Questionnaire (HAQ)], visual analogue pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
American Collage of Rheumatology 20% Response Criteria (ACR20) Response Rates at Weeks 8, 16, 24, 36 and 52 ACR20 Week 8	39 participants Interval 31.7 to 51.1	33 participants Interval 26.51 to 45.61	44 participants Interval 37.91 to 57.91
American Collage of Rheumatology 20% Response Criteria (ACR20) Response Rates at Weeks 8, 16, 24, 36 and 52 ACR20 Week 16	50 participants Interval 43.18 to 62.95	54 participants Interval 48.48 to 68.21	53 participants Interval 47.98 to 67.84
American Collage of Rheumatology 20% Response Criteria (ACR20) Response Rates at Weeks 8, 16, 24, 36 and 52 ACR20 Week 24	36 participants Interval 28.79 to 49.35	31 participants Interval 26.37 to 46.11	34 participants Interval 29.86 to 50.1
American Collage of Rheumatology 20% Response Criteria (ACR20) Response Rates at Weeks 8, 16, 24, 36 and 52 ACR20 Week 36	63 participants Interval 59.87 to 78.49	47 participants Interval 46.52 to 67.46	58 participants Interval 58.0 to 78.69
American Collage of Rheumatology 20% Response Criteria (ACR20) Response Rates at Weeks 8, 16, 24, 36 and 52 ACR20 Week 52 (EOS)	60 participants Interval 53.75 to 72.82	49 participants Interval 44.18 to 64.34	59 participants Interval 55.98 to 75.26

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Efficacy endpoint: American Collage of Rheumatology 50% response criteria (ACR50) response rates and American Collage of Rheumatology 70% response criteria (ACR70) at weeks 8, 16, 24, 36 and 52.

An ACR50 response is defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [Health Assessment Questionnaire (HAQ)], visual analogue pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).

An ACR70 response is defined as both improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [Health Assessment Questionnaire (HAQ)], visual analogue pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52 ACR50 Week 8	13 participants Interval 8.17 to 22.02	11 participants Interval 6.73 to 19.95	14 participants Interval 9.29 to 23.94
American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52 ACR70 Week 8	2 participants Interval 0.58 to 7.35	2 participants Interval 0.59 to 7.51	2 participants Interval 0.6 to 7.58
American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52 ACR50 Week 16	17 participants Interval 11.61 to 27.07	16 participants Interval 11.0 to 26.4	14 participants Interval 9.39 to 24.18
American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52 ACR70 Week 16	9 participants Interval 5.12 to 17.2	4 participants Interval 1.7 to 10.65	5 participants Interval 2.37 to 12.22
American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52 ACR50 Week 24	15 participants Interval 10.14 to 25.17	8 participants Interval 4.73 to 17.11	5 participants Interval 2.51 to 12.9
American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52 ACR70 Week 24	8 participants Interval 4.47 to 16.23	2 participants Interval 0.63 to 8.0	3 participants Interval 1.19 to 9.76
American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52 ACR50 Week 36	37 participants Interval 31.51 to 51.44	19 participants Interval 15.37 to 33.38	25 participants Interval 21.31 to 40.69
American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52 ACR70 Week 36	19 participants Interval 13.95 to 30.63	6 participants Interval 3.4 to 15.06	12 participants Interval 8.47 to 23.59
American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52 ACR50 Week 52 (EOS)	35 participants Interval 28.14 to 47.33	25 participants Interval 19.58 to 37.8	30 participants Interval 24.74 to 44.02
American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52 ACR70 Week 52 (EOS)	23 participants Interval 16.89 to 34.05	13 participants Interval 8.64 to 23.16	17 participants Interval 12.28 to 28.48

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Efficacy endpoint: Individual components of the ACR improvement criteria on Day 1 and at weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and tender joint count (TJC) (the 66/68 joint count system). SJC and TJC assess the level of skeletal disease involvement. The 66/68 Joint Count evaluates 66 joints for swelling and 68 joints for tenderness.

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Swollen Joint Count Day 1	15.2 Joints Standard Deviation 7.97	15.2 Joints Standard Deviation 15.2	13.0 Joints Standard Deviation 6.19
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Swollen Joint Count Week 8	8.6 Joints Standard Deviation 7.11	8.4 Joints Standard Deviation 6.62	7.7 Joints Standard Deviation 5.92
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Swollen Joint Count 16	6.5 Joints Standard Deviation 4.86	7.8 Joints Standard Deviation 7.20	7.0 Joints Standard Deviation 5.37
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Swollen Joint Count 24	8.5 Joints Standard Deviation 5.13	10.0 Joints Standard Deviation 5.85	10.0 Joints Standard Deviation 6.19
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Swollen Joint Count 36	4.8 Joints Standard Deviation 6.21	5.4 Joints Standard Deviation 5.72	5.7 Joints Standard Deviation 5.49
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Swollen Joint Count Week 52 (EOS)	5.2 Joints Standard Deviation 6.53	6.5 Joints Standard Deviation 9.46	4.6 Joints Standard Deviation 5.04
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Tender Joint Count Day 1	21.7 Joints Standard Deviation 11.08	22.6 Joints Standard Deviation 13.66	20.0 Joints Standard Deviation 10.84
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Tender Joint Score Week 8	13.9 Joints Standard Deviation 9.94	14.0 Joints Standard Deviation 9.94	13.5 Joints Standard Deviation 10.69
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Tender Joint Count Week 16	11.1 Joints Standard Deviation 10.24	12.5 Joints Standard Deviation 8.36	11.8 Joints Standard Deviation 9.09
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Tender Joint Score Week 24	13.6 Joints Standard Deviation 9.79	15.6 Joints Standard Deviation 11.94	15.2 Joints Standard Deviation 11.62
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Tender Joint Score Week 36	8.3 Joints Standard Deviation 9.10	10.9 Joints Standard Deviation 10.68	9.6 Joints Standard Deviation 10.81
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System) Tender Joint Score Week 52 (EOS)	9.3 Joints Standard Deviation 9.34	11.9 Joints Standard Deviation 15.18	9.4 Joints Standard Deviation 11.41

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Efficacy endpoint: Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Physicians global assessment of disease activity (assessed on 1 to 100 mm Visual Analog Scale [VAS]). Where 0 = no disease activity and 100 = maximum disease activity.

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Physicians Global Assessment of Disease Activity (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Disease Activty iDay 1	71.0 score on a scale Standard Error 14.30	69.4 score on a scale Standard Error 15.00	69.8 score on a scale Standard Error 14.32
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Physicians Global Assessment of Disease Activity (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Disease Activity Week 8	45.6 score on a scale Standard Error 20.75	43.2 score on a scale Standard Error 23.86	44.6 score on a scale Standard Error 23.28
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Physicians Global Assessment of Disease Activity (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Disease Activtiy Week 16	39.2 score on a scale Standard Error 20.94	39.0 score on a scale Standard Error 20.97	42.3 score on a scale Standard Error 20.89
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Physicians Global Assessment of Disease Activity (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Disease Activity Week 24	47.9 score on a scale Standard Error 22.28	47.8 score on a scale Standard Error 20.25	49.0 score on a scale Standard Error 22.45
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Physicians Global Assessment of Disease Activity (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Disease Activtiy Week 36	30.3 score on a scale Standard Error 21.56	36.3 score on a scale Standard Error 21.71	31.4 score on a scale Standard Error 20.69
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Physicians Global Assessment of Disease Activity (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Disease Activity Week 52 (EOS)	31.1 score on a scale Standard Error 21.67	35.1 score on a scale Standard Error 23.49	31.2 score on a scale Standard Error 22.95

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Participants assessment of pain (assessed on 1 to 100 mm Visual Analog Scale [VAS]). Participants assessment of pain (assessed on 1 to 100 mm Visual Analog Scale [VAS]) where 0 = no pain and 100 = severe pain.

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Pain (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Assessment of Pain Day 1	67.0 score on a scale Standard Deviation 18.71	68.8 score on a scale Standard Deviation 20.02	68.8 score on a scale Standard Deviation 19.27
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Pain (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Assessment of Pain Week 8	48.4 score on a scale Standard Deviation 22.79	50.4 score on a scale Standard Deviation 22.40	47.9 score on a scale Standard Deviation 23.03
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Pain (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Assessment of Pain Week 16	42.7 score on a scale Standard Deviation 23.34	44.6 score on a scale Standard Deviation 20.91	44.4 score on a scale Standard Deviation 22.91
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Pain (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Assessment of Pain Week 24	49.3 score on a scale Standard Deviation 24.15	51.6 score on a scale Standard Deviation 21.44	51.8 score on a scale Standard Deviation 23.58
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Pain (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Assessment of Pain Week 36	36.8 score on a scale Standard Deviation 24.56	44.9 score on a scale Standard Deviation 23.78	41.6 score on a scale Standard Deviation 23.46
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Pain (Assessed on 1 to 100 mm Visual Analog Scale [VAS]) Assessment of Pain Week 52 (EOS)	41.2 score on a scale Standard Deviation 24.34	43.2 score on a scale Standard Deviation 24.42	44.5 score on a scale Standard Deviation 26.10

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Efficacy endpoint: Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants global assessment of disease activity (assessed on 1 to 100 mm visual analogue scale [VAS]). Patients rate how their Rheumatoid Arthritis has affected them, where 0 = very well and 100 = very poor.

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Global Assessment of Disease Activity (Assessed on 1 to 100 mm VAS) Disease activity Week 36	35.7 score on a scale Standard Deviation 22.63	42.7 score on a scale Standard Deviation 22.54	42.5 score on a scale Standard Deviation 23.70
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Global Assessment of Disease Activity (Assessed on 1 to 100 mm VAS) Disease activity Day 1	68.9 score on a scale Standard Deviation 15.87	67.6 score on a scale Standard Deviation 17.53	70.8 score on a scale Standard Deviation 17.04
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Global Assessment of Disease Activity (Assessed on 1 to 100 mm VAS) Disease activity Week 8	46.9 score on a scale Standard Deviation 22.57	49.1 score on a scale Standard Deviation 22.98	48.5 score on a scale Standard Deviation 22.93
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Global Assessment of Disease Activity (Assessed on 1 to 100 mm VAS) Disease activity Week 16	43.9 score on a scale Standard Deviation 21.47	44.4 score on a scale Standard Deviation 21.63	44.2 score on a scale Standard Deviation 22.82
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Global Assessment of Disease Activity (Assessed on 1 to 100 mm VAS) Disease activity Week 24	50.8 score on a scale Standard Deviation 23.16	51.1 score on a scale Standard Deviation 20.49	52.3 score on a scale Standard Deviation 21.90
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Global Assessment of Disease Activity (Assessed on 1 to 100 mm VAS) Disease activity Week 52 (EOS)	41.4 score on a scale Standard Deviation 23.02	42.4 score on a scale Standard Deviation 24.10	43.1 score on a scale Standard Deviation 23.93

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

the Health Assessment Questionnaire-Disability Index (HAQ-DI) contains 20 questions split into 8 categories (dressing & grooming, arising, eating, walking, hygiene, reach, grip & activities). Scores were: 0 = Without ANY Difficulty; 1 = With SOME Difficulty; 2 = With MUCH Difficulty; 3 = UNABLE to Do. Total scores were calculated as the summed category scores divided by the number of categories.

Total HAQ-DI scores are presented which range from 0 to 3. Higher scores represent a worse outcome. Scores of 0 to 1 represent mild to moderate difficulty, 1 to 2 moderate disability, and 2 to 3 severe to very severe disability.

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Disability (Health Assessment Questionnaire-Disability Index [HAQ-DI]) HAQ-DI Day 1	1.610 score on a scale Standard Deviation 0.5728	1.605 score on a scale Standard Deviation 0.6567	1.585 score on a scale Standard Deviation 0.6421
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Disability (Health Assessment Questionnaire-Disability Index [HAQ-DI]) HAQ-DI Week 8	1.168 score on a scale Standard Deviation 0.6318	1.314 score on a scale Standard Deviation 0.6919	1.176 score on a scale Standard Deviation 0.6398
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Disability (Health Assessment Questionnaire-Disability Index [HAQ-DI]) HAQ-DI Week 16	1.129 score on a scale Standard Deviation 0.5775	1.246 score on a scale Standard Deviation 0.6394	1.152 score on a scale Standard Deviation 0.6668
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Disability (Health Assessment Questionnaire-Disability Index [HAQ-DI]) HAQ-DI Week 24	1.209 score on a scale Standard Deviation 0.6071	1.335 score on a scale Standard Deviation 0.6381	1.294 score on a scale Standard Deviation 0.6594
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Disability (Health Assessment Questionnaire-Disability Index [HAQ-DI]) HAQ-DI Week 36	0.994 score on a scale Standard Deviation 0.6220	1.182 score on a scale Standard Deviation 0.6883	1.061 score on a scale Standard Deviation 0.6247
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Disability (Health Assessment Questionnaire-Disability Index [HAQ-DI]) HAQ-DI Week 52 (EOS)	1.027 score on a scale Standard Deviation 0.6208	1.207 score on a scale Standard Deviation 0.7025	1.190 score on a scale Standard Deviation 0.7116

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

C-reactive protein (CRP) level (Mg/L). CRP is a marker for inflammation. a normal reading is <3 Mg/L. Higher values indicate disease related inflammation and increased cardiovascular risk.

CRP levels between 3 Mg/L and 10 Mg/L are mildly elevated. Levels between 10 Mg/L and 100 Mg/L are moderately elevated and CRP levels above 100 Mg/L are severely elevated.

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: C-reactive Protein (CRP) Level CRP Day 1	19.5 Mg/L Standard Deviation 28.99	15.3 Mg/L Standard Deviation 20.63	16.2 Mg/L Standard Deviation 17.91
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: C-reactive Protein (CRP) Level CRP Week 8	12.5 Mg/L Standard Deviation 15.78	12.3 Mg/L Standard Deviation 20.29	10.4 Mg/L Standard Deviation 12.78
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: C-reactive Protein (CRP) Level CRP Week 16	8.5 Mg/L Standard Deviation 11.78	7.2 Mg/L Standard Deviation 9.02	7.3 Mg/L Standard Deviation 6.90
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: C-reactive Protein (CRP) Level CRP Week 24	9.5 Mg/L Standard Deviation 14.54	8.3 Mg/L Standard Deviation 14.40	7.9 Mg/L Standard Deviation 10.35
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: C-reactive Protein (CRP) Level CRP Week 36	8.0 Mg/L Standard Deviation 20.33	7.0 Mg/L Standard Deviation 10.38	7.1 Mg/L Standard Deviation 9.72
Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: C-reactive Protein (CRP) Level CRP Week 52 (EOS)	9.8 Mg/L Standard Deviation 14.14	9.1 Mg/L Standard Deviation 14.93	7.4 Mg/L Standard Deviation 11.34

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Disease Activity Score 28- Erythrocyte Sedimentation Rate (DAS28-ESR) consisted of tender joint counts (TJC), swollen joint counts (SJC) & erythrocyte sedimentation rate (ESR). The formula is: [0.56*SQRT(tender 28 joint count)+0.28*SQRT(swollen 28 joint count)+0.7*ln(ESR)]+0.014*patient global health assessment.

Total DAS28-ESR scores are presented. Total scores range from 2 (minimum) to 10 (maximum). A lower score represents a better patient outcome. A DAS28-ESR of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Change From Baseline DAS28-erythrocyte Sedimentation Rate (ESR) at Weeks 8, 16, 24, 36 and 52 DAS28-ESR Day 1	6.537 score on a scale Standard Deviation 0.8440	6.533 score on a scale Standard Deviation .07810	6.480 score on a scale Standard Deviation 0.7577
Change From Baseline DAS28-erythrocyte Sedimentation Rate (ESR) at Weeks 8, 16, 24, 36 and 52 DAS28-ESR Week 8	5.330 score on a scale Standard Deviation 1.0649	5.315 score on a scale Standard Deviation 1.2478	5.235 score on a scale Standard Deviation 1.2578
Change From Baseline DAS28-erythrocyte Sedimentation Rate (ESR) at Weeks 8, 16, 24, 36 and 52 DAS28-ESR Week 16	4.861 score on a scale Standard Deviation 1.1876	5.059 score on a scale Standard Deviation 1.1682	4.957 score on a scale Standard Deviation 1.1802
Change From Baseline DAS28-erythrocyte Sedimentation Rate (ESR) at Weeks 8, 16, 24, 36 and 52 DAS28-ESR Week 24	5.216 score on a scale Standard Deviation 1.2510	5.410 score on a scale Standard Deviation 1.2344	5.432 score on a scale Standard Deviation 1.1891
Change From Baseline DAS28-erythrocyte Sedimentation Rate (ESR) at Weeks 8, 16, 24, 36 and 52 DAS28-ESR Week 36	4.319 score on a scale Standard Deviation 1.2798	4.689 score on a scale Standard Deviation 1.0077	4.499 score on a scale Standard Deviation 1.1980
Change From Baseline DAS28-erythrocyte Sedimentation Rate (ESR) at Weeks 8, 16, 24, 36 and 52 DAS28-ESR Week 52 (EOS)	4.435 score on a scale Standard Deviation 1.4375	4.485 score on a scale Standard Deviation 1.4390	4.391 score on a scale Standard Deviation 1.3947

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Efficacy endpoint: number of participants with a major clinical response defined as a continuous ACR70 from Baseline (Day 1) for at least 24 weeks.

ACR70 is a measure based on American College of Rheumatology criteria of at least a 70% improvement in the number of tender and swollen joints, and a 70% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assessment of function measured using the Stanford Health Assessment Questionnaire the physician's global assessment of disease status; serum C-reactive protein levels.

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Number of Participants With a Major Clinical Response (Continuous ACR70) for at Least 24 Weeks Major Clinical Response Week 24	1 participants Interval 0.19 to 5.9	0 participants Interval 0.0 to 4.28	0 participants Interval 0.0 to 4.32
Number of Participants With a Major Clinical Response (Continuous ACR70) for at Least 24 Weeks Major Clinical Response Week 52 (EOS)	2 participants Interval 0.62 to 7.83	0 participants Interval 0.0 to 4.53	1 participants Interval 0.22 to 6.75

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Number if Participants with a Clinical Remission Response (CRR) defined by the Simplified Disease Activity Index (SDAI) <3.3 at weeks 8, 16, 24, 36 and 52 (EOS).

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Number of Participants With a Clinical Remission Response (CRR) at Weeks 8, 16, 24, 36 and 52 CRR Week 8	0 participants Interval 0.0 to 3.97	0 participants Interval 0.0 to 4.01	0 participants Interval 0.0 to 4.05
Number of Participants With a Clinical Remission Response (CRR) at Weeks 8, 16, 24, 36 and 52 CRR Week 16	0 participants Interval 0.0 to 4.01	1 participants Interval 0.19 to 5.84	0 participants Interval 0.0 to 4.05
Number of Participants With a Clinical Remission Response (CRR) at Weeks 8, 16, 24, 36 and 52 CRR Week 24	0 participants Interval 0.0 to 4.09	1 participants Interval 0.2 to 6.23	0 participants Interval 0.0 to 4.37
Number of Participants With a Clinical Remission Response (CRR) at Weeks 8, 16, 24, 36 and 52 CRR Week 36	2 participants Interval 0.61 to 7.74	0 participants Interval 0.0 to 4.48	1 participants Interval 0.21 to 6.51
Number of Participants With a Clinical Remission Response (CRR) at Weeks 8, 16, 24, 36 and 52 CRR Week 52 (EOS)	1 participants Interval 0.19 to 5.9	2 participants Interval 0.63 to 7.91	2 participants Interval 0.64 to 8.09

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Efficacy endpoint: Proportion of participants with European League Against Rheumatism (EULAR) response (defined as good response, moderate response or no response) at weeks 8, 16, 24 36 and 52 (EOS). EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The DAS28-CRP was classified into 3 categories: low disease activity (<= 3.2), moderate disease activity (> 3.2 and <= 5.1) and high disease activity (> 5.1). Good response was defined as >1.2 improvement in the DAS28-CRP from baseline with low disease activity.

Outcome measures

Measure	SAIT101 n=98 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=98 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=98 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52 Week 8 Good	12 participants Interval 7.54 to 21.21	14 participants Interval 9.29 to 23.94	12 participants Interval 7.54 to 21.21
Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52 Week 8 Good or Moderate	30 participants Interval 23.62 to 42.3	33 participants Interval 26.82 to 46.05	33 participants Interval 26.51 to 45.61
Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52 Week 16 Good	20 participants Interval 14.38 to 30.9	12 participants Interval 7.62 to 21.43	13 participants Interval 8.45 to 22.69
Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52 Week 16 Good or Moderate	44 participants Interval 37.47 to 57.36	42 participants Interval 35.85 to 55.8	33 participants Interval 26.82 to 46.05
Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52 Week 24 Good	12 participants Interval 7.71 to 21.65	7 participants Interval 3.95 to 15.69	7 participants Interval 4.05 to 16.04
Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52 Week 24 Good or Moderate	30 participants Interval 24.17 to 43.14	26 participants Interval 21.28 to 40.19	23 participants Interval 18.76 to 37.34
Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52 Week 36 Good	27 participants Interval 21.51 to 40.13	15 participants Interval 11.41 to 28.01	27 participants Interval 23.13 to 42.72
Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52 Week 36 Good or Moderate	58 participants Interval 54.15 to 73.56	50 participants Interval 50.0 to 70.82	54 participants Interval 53.62 to 73.7
Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52 Week 52 (EOS) Good	34 participants Interval 27.8 to 47.16	31 participants Interval 26.37 to 46.11	32 participants Interval 27.41 to 47.27
Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52 Week 52 (EOS) Good or Moderate	59 participants Interval 53.95 to 73.18	50 participants Interval 46.98 to 67.33	63 participants Interval 62.23 to 80.71

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 8, 16, 24, 36 and 52 (EOS)

Population: Pharmacodynamic Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Change from baseline (Day 1) in immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) levels (mg/dL) at Week 8, 16, 24 36 and 52 (End of study)

Outcome measures

Measure	SAIT101 n=95 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=96 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=93 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgG Screening	1231.0 Mg/dL Standard Deviation 299.36	1230.1 Mg/dL Standard Deviation 365.54	1203.4 Mg/dL Standard Deviation 373.29
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgG Week 8	1108.0 Mg/dL Standard Deviation 242.20	1080.6 Mg/dL Standard Deviation 279.75	1038.5 Mg/dL Standard Deviation 290.01
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgG Week 16	1105.2 Mg/dL Standard Deviation 232.51	1075.7 Mg/dL Standard Deviation 277.51	1038.5 Mg/dL Standard Deviation 290.01
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgG Week 24	1114.6 Mg/dL Standard Deviation 251.78	1077.2 Mg/dL Standard Deviation 265.55	1023.2 Mg/dL Standard Deviation 278.70
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgG Week 36	1076.6 Mg/dL Standard Deviation 246.62	1060.9 Mg/dL Standard Deviation 305.12	976.6 Mg/dL Standard Deviation 249.11
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgG Week 52 (EOS)	1102.0 Mg/dL Standard Deviation 274.44	1081.1 Mg/dL Standard Deviation 285.13	999.9 Mg/dL Standard Deviation 232.03
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgM Screening	164.3 Mg/dL Standard Deviation 76.07	167.9 Mg/dL Standard Deviation 100.16	159.0 Mg/dL Standard Deviation 81.36
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgM Week 8	137.5 Mg/dL Standard Deviation 71.38	132.6 Mg/dL Standard Deviation 83.58	128.9 Mg/dL Standard Deviation 68.50
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgM Week 16	123.7 Mg/dL Standard Deviation 61.08	124.9 Mg/dL Standard Deviation 85.71	117.0 Mg/dL Standard Deviation 60.44
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgM Week 24	123.3 Mg/dL Standard Deviation 62.37	117.1 Mg/dL Standard Deviation 80.96	109.9 Mg/dL Standard Deviation 73.11
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgM Week 36	111.7 Mg/dL Standard Deviation 56.89	108.0 Mg/dL Standard Deviation 77.79	99.7 Mg/dL Standard Deviation 56.38
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgM Week 52 (EOS)	109.6 Mg/dL Standard Deviation 56.80	107.6 Mg/dL Standard Deviation 77.00	95.2 Mg/dL Standard Deviation 52.57
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgA Screening	321.1 Mg/dL Standard Deviation 269.22	283.4 Mg/dL Standard Deviation 134.80	342.9 Mg/dL Standard Deviation 153.24
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgA Week 8	293.6 Mg/dL Standard Deviation 176.04	264.4 Mg/dL Standard Deviation 121.41	316.5 Mg/dL Standard Deviation 146.15
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgA Week 16	301.8 Mg/dL Standard Deviation 204.14	253.0 Mg/dL Standard Deviation 111.58	312.7 Mg/dL Standard Deviation 151.87
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgA Week 24	279.8 Mg/dL Standard Deviation 119.87	263.0 Mg/dL Standard Deviation 121.15	307.7 Mg/dL Standard Deviation 147.92
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgA Week 36	283.8 Mg/dL Standard Deviation 204.12	259.2 Mg/dL Standard Deviation 116.55	297.1 Mg/dL Standard Deviation 146.85
Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels) IgA Week 52	269.4 Mg/dL Standard Deviation 116.74	254.7 Mg/dL Standard Deviation 115.38	297.8 Mg/dL Standard Deviation 138.63

OTHER_PRE_SPECIFIED outcome

Timeframe: Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacokinetic data set

Pharmacodynamic endpoint: proportion of participants (n) with depletion of CD19+ B-cell count up to week 24 (Pharmacodynamic analysis set).

Outcome measures

Measure	SAIT101 n=95 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=96 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=94 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Pharmacodynamic Endpoint: Depletion of B-lymphocyte Antigen CD19 (CD19+) B-cell Count up to Week 24	45 participants	46 participants	50 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36 and 52. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacodynamic Analysis Set. Two participants in the SAIT101 arm, 3 participants in the MabThera arm and 3 participants in the Rituxan arm were excluded from the analysis either as they had a depleted C-cell count at baseline and / or if the Week 24 assessment was missing.

Time needed to CD19+ B-cell depletion in Part A (calculated as the first time CD19+ B-cell count below 20/µL minus time of first dosing in days).

Outcome measures

Measure	SAIT101 n=93 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=93 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=90 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Pharmacodynamic Endpoint: Time Needed to CD19+ B-cell Depletion	1.524 Days Standard Deviation 2.6274	2.847 Days Standard Deviation 9.1286	2.223 Days Standard Deviation 9.0833

OTHER_PRE_SPECIFIED outcome

Timeframe: Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36 and 52. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacodynamic Analysis Set.Pharmacodynamic Analysis Set. Fifty seven participants in the SAIT101 arm, 70 participants in the MabThera arm and 72 participants in the Rituxan arm were excluded from the analysis either as they had a depleted C-cell count at baseline or if the Week 24 assessment was missing.

Duration of CD19+ B-cell depletion (only participants that returned to non-depletion at or before week 24 were included)

Outcome measures

Measure	SAIT101 n=36 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=26 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=21 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Pharmacodynamic Endpoint: Duration of CD19+ B-cell Depletion	78.444 Days Standard Deviation 77.5290	85.856 Days Standard Deviation 73.4460	77.290 Days Standard Deviation 72.0557

OTHER_PRE_SPECIFIED outcome

Timeframe: Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36 and 52. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacodynamic Analysis Set

Number of participants with CD19+ B-cell count recover versus baseline. Incidence of B-Cell recovery was defined as either CD19+ B-cell counts retuned to baseline or the lower limit or normal of 110 cells/µL at week 24).

Outcome measures

Measure	SAIT101 n=93 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=93 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=90 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Pharmacodynamic Endpoint: Number of Participants With CD19+ B-cell Count Recover Versus Baseline	5 Participants	4 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36 and 52. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacodynamic Analysis Set. AUC0-d15 could not be determined for 23 participants in the SAIT101 arm, 20 participants in the MabThera arm and 20 participants in the Rituxan arm as either the baseline data was missing and /or there was a missing b-cell could at the last timepoint.

Area under the concentration time curve of CD19 B-cell count change at Day 15 (AUEC0-d15) and week 24 (AUEC0-w24) based on change from baseline and percent of baseline values

Outcome measures

Measure	SAIT101 n=72 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=76 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=73 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Pharmaco Endpoint: Area Under the Concentration Time Curve of CD19 B-cell Count Change at Day 15 and Week 24 AUEC(0-d15)	-2650.0 cells*day/µL) Interval -2786.0 to -2513.9	-2672.1 cells*day/µL) Interval -2804.9 to -2539.3	-2719.4 cells*day/µL) Interval -2855.3 to 2583.6
Pharmaco Endpoint: Area Under the Concentration Time Curve of CD19 B-cell Count Change at Day 15 and Week 24 AUEC(0-w24)	-32707.6 cells*day/µL) Interval -33128.1 to -32287.1	-33018.3 cells*day/µL) Interval -33440.4 to -32596.2	-33003.7 cells*day/µL) Interval -33442.8 to -32564.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.

Population: Pharmacodynamic Analysis Set. participants in the SAIT101 arm, Twenty three participants in the MabThera arm, 20 participants in the MabThera and 20 participants in the Rituxan arm were excluded from the analysis either as they had a depleted C-cell count at baseline and / or the Week 24 assessment was missing.

Pharmacodynamic endpoint: Descriptive statistics (mean [SD]) of the change from baseline in CD19+ B-cell count during the study period (Day 15 [AUEC(0-d15] and Week 24 [AUEC(0-w24])

Outcome measures

Measure	SAIT101 n=72 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=76 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=73 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Pharmacodynamic Endpoint: Change From Baseline in CD19+ B-cell Count During the Study Period AUEC(0-d15)	-2729 Cells*day/µL Standard Deviation 1915.3	-2935 Cells*day/µL Standard Deviation 2222.1	-2367 Cells*day/µL Standard Deviation 1978.1
Pharmacodynamic Endpoint: Change From Baseline in CD19+ B-cell Count During the Study Period AUEC(0-w24)	-33500 Cells*day/µL Standard Deviation 23881	-36410 Cells*day/µL Standard Deviation 22883	-28500 Cells*day/µL Standard Deviation 20878

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1) and Weeks 8, 16, 24, 26 & 52 (EOS)

Population: Pharmacodynamic Analysis Set

Pharmacodynamic endpoint: Change from baseline (Day 1) in C-reactive protein (CRP) levels (mg/dL) at weeks 8, 16, 24, 36 and 52 (EOS)

Outcome measures

Measure	SAIT101 n=95 Participants 1000 mg intravenous (iv) SAIT101 on Day 1 and 15 (Part A). 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,	MabThera n=96 Participants 1000 mg iv MabThera on Day 1 and 15 (Part A). 1000 mg iv MabThera on week 24 and 26 (Part B) for eligible participants.	Rituxan n=93 Participants 1000 mg iv of Rituxan on Day 1 and 15 (Part A). 1000 mg iv of Rituxan on week 24 and 26 (Part B) for eligible participants
Pharmacodynamic Endpoint: Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 8, 16, 24, 36 and 52 CRP Week 8	12.5 Mg/dL Standard Deviation 15.78	12.3 Mg/dL Standard Deviation 20.29	10.4 Mg/dL Standard Deviation 12.85
Pharmacodynamic Endpoint: Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 8, 16, 24, 36 and 52 CRP Day 1	19.5 Mg/dL Standard Deviation 29.50	15.5 Mg/dL Standard Deviation 20.76	16.1 Mg/dL Standard Deviation 17.64
Pharmacodynamic Endpoint: Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 8, 16, 24, 36 and 52 CRP Week 16	8.5 Mg/dL Standard Deviation 11.78	7.2 Mg/dL Standard Deviation 9.02	7.3 Mg/dL Standard Deviation 6.90
Pharmacodynamic Endpoint: Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 8, 16, 24, 36 and 52 CRP Week 24	9.5 Mg/dL Standard Deviation 14.54	8.3 Mg/dL Standard Deviation 14.40	7.9 Mg/dL Standard Deviation 10.35
Pharmacodynamic Endpoint: Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 8, 16, 24, 36 and 52 CRP Week 36	8.0 Mg/dL Standard Deviation 10.33	7.0 Mg/dL Standard Deviation 10.38	7.1 Mg/dL Standard Deviation 9.72
Pharmacodynamic Endpoint: Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 8, 16, 24, 36 and 52 CRP Week 52 (EOS)	9.8 Mg/dL Standard Deviation 14.28	9.1 Mg/dL Standard Deviation 15.01	7.3 Mg/dL Standard Deviation 11.33

Adverse Events

SAIT101

Serious events: 7 serious events

Other events: 39 other events

Deaths: 0 deaths

MabThera

Serious events: 7 serious events

Other events: 37 other events

Deaths: 0 deaths

Rituxan

Serious events: 13 serious events

Other events: 43 other events

Deaths: 1 deaths

Serious adverse events

Measure	SAIT101 n=98 participants at risk SAIT101: 1,000 mg i.v. of SAIT101 on Day 1 and 15. 1,000 mg i.v. of SAIT101 on week 24 and 26 for eligible participants.	MabThera n=98 participants at risk MabThera: 1,000 mg i.v. of MabThera® on Day 1 and 15. 1,000 mg i.v. of MabThera® on week 24 and 26 for eligible participants.	Rituxan n=98 participants at risk Rituxan: 1,000 mg i.v. of Rituxan® on Day 1 and 15. 1,000 mg i.v. of Rituxan® on week 24 and 26 for eligible participants.
Infections and infestations Herpes zoster	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	2.0% 2/98 • Number of events 2 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Cellulitis	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Hepatitis B	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Hepatitis B reactivation	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Herpes simplex	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Lower respiratory tract infection	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Meningitis	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Meningitis bacterial	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Nasopharyngitis	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Pyelonephritis acute	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Urinary tract infection	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Urosepsis	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Injury, poisoning and procedural complications Subdural hematoma	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Blood and lymphatic system disorders Anemia	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Blood and lymphatic system disorders Febrile neutropenia	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Immune system disorders Anaphylactic reaction	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Immune system disorders Drug hypersensitivity	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Musculoskeletal and connective tissue disorders Oseoarthritis	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Renal and urinary disorders Acute kidney injury	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Renal and urinary disorders Renal cyst	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Cardiac disorders Cardiac failure	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 2 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Metabolism and nutrition disorders Hypokalemia	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Nervous system disorders Epilepsy	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	0.00% 0/98 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Other adverse events

Measure	SAIT101 n=98 participants at risk SAIT101: 1,000 mg i.v. of SAIT101 on Day 1 and 15. 1,000 mg i.v. of SAIT101 on week 24 and 26 for eligible participants.	MabThera n=98 participants at risk MabThera: 1,000 mg i.v. of MabThera® on Day 1 and 15. 1,000 mg i.v. of MabThera® on week 24 and 26 for eligible participants.	Rituxan n=98 participants at risk Rituxan: 1,000 mg i.v. of Rituxan® on Day 1 and 15. 1,000 mg i.v. of Rituxan® on week 24 and 26 for eligible participants.
Infections and infestations Urinary tract infection	13.3% 13/98 • Number of events 14 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	4.1% 4/98 • Number of events 6 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	8.2% 8/98 • Number of events 10 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Upper respiratory tract infection	5.1% 5/98 • Number of events 5 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	8.2% 8/98 • Number of events 10 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	5.1% 5/98 • Number of events 5 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Infections and infestations Nasopharyngitis	7.1% 7/98 • Number of events 9 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	3.1% 3/98 • Number of events 4 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	7.1% 7/98 • Number of events 7 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	4.1% 4/98 • Number of events 7 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	6.1% 6/98 • Number of events 6 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	6.1% 6/98 • Number of events 7 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Blood and lymphatic system disorders Anemia	3.1% 3/98 • Number of events 3 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	8.2% 8/98 • Number of events 9 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	3.1% 3/98 • Number of events 3 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Gastrointestinal disorders Gastritis	3.1% 3/98 • Number of events 3 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	1.0% 1/98 • Number of events 1 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	5.1% 5/98 • Number of events 5 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Injury, poisoning and procedural complications Infusion related reaction	2.0% 2/98 • Number of events 2 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	2.0% 2/98 • Number of events 2 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	7.1% 7/98 • Number of events 8 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).
Vascular disorders Hypertension	2.0% 2/98 • Number of events 2 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	5.1% 5/98 • Number of events 5 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).	2.0% 2/98 • Number of events 2 • After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such s biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 52 Data-cut off. Safety Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).

Additional Information

Medical Director

Archigen Biotech Ltd

Phone: +44(0)20 3749 5000

Email: info@archigenbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place