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Trial record 1 of 83 for:    SAIT101
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PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02819726
Recruitment Status : Completed
First Posted : June 30, 2016
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Archigen Biotech Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: SAIT101
Biological: MabThera
Biological: Rituxan
Enrollment 294
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title SAIT101 (Part A and B) MabThera (Part A and B) Rituxan (Part A and B) SAIT101 (Part B Only)
Hide Arm/Group Description 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, 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. 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 1000 mg iv SAIT101 on week 24 and 26 (Part B) for eligible participants,
Period Title: Part A (All Participants)
Started [1] 98 98 98 0
Completed 92 88 87 0
Not Completed 6 10 11 0
Reason Not Completed
Lost to Follow-up             0             1             0             0
Withdrawal by Subject             3             5             6             0
Protocol non-compliance             3             4             5             0
[1]
Received at least 1 infusion of study treatment in Part A
Period Title: Part B (All Participants)
Started [1] 73 [2] 70 [3] 39 [4] 38 [4]
Completed 70 68 35 36
Not Completed 3 2 4 2
Reason Not Completed
Lost to Follow-up             1             1             2             2
Withdrawal by Subject             2             1             1             0
Protocol non-compliance             0             0             1             0
[1]
Received at least 1 infusion of treatment in Part B. 220 participants were re-treated in Part B
[2]
19 participants who completed Part A were not eligible for Part B
[3]
18 participants completing Part A were not eligible for Part B
[4]
5 participants completing Part A were ineligible for Part B.
Arm/Group Title SAIT101 MabThera Rituxan Total
Hide Arm/Group Description 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: 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: 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 of all reporting groups
Overall Number of Baseline Participants 98 98 98 294
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 98 participants 98 participants 294 participants
50.9  (12.41) 52.5  (10.87) 52.1  (12.09) 51.8  (11.79)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
18-60 years Number Analyzed 98 participants 98 participants 98 participants 294 participants
76
  77.6%
75
  76.5%
71
  72.4%
222
  75.5%
>60 years Number Analyzed 98 participants 98 participants 98 participants 294 participants
22
  22.4%
23
  23.5%
27
  27.6%
72
  24.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 98 participants 98 participants 294 participants
Female
79
  80.6%
81
  82.7%
80
  81.6%
240
  81.6%
Male
19
  19.4%
17
  17.3%
18
  18.4%
54
  18.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 98 participants 98 participants 294 participants
Hispanic or Latino
30
  30.6%
30
  30.6%
29
  29.6%
89
  30.3%
Not Hispanic or Latino
68
  69.4%
68
  69.4%
69
  70.4%
205
  69.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 98 participants 98 participants 294 participants
American Indian or Alaska Native
24
  24.5%
20
  20.4%
21
  21.4%
65
  22.1%
Asian
18
  18.4%
19
  19.4%
24
  24.5%
61
  20.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   2.0%
0
   0.0%
1
   1.0%
3
   1.0%
White
52
  53.1%
56
  57.1%
52
  53.1%
160
  54.4%
More than one race
2
   2.0%
3
   3.1%
0
   0.0%
5
   1.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Korea Number Analyzed 98 participants 98 participants 98 participants 294 participants
5 3 6 14
Hungary Number Analyzed 98 participants 98 participants 98 participants 294 participants
3 0 4 7
Czechia Number Analyzed 98 participants 98 participants 98 participants 294 participants
7 3 2 12
United States Number Analyzed 98 participants 98 participants 98 participants 294 participants
9 13 6 28
Poland Number Analyzed 98 participants 98 participants 98 participants 294 participants
15 19 23 57
Mexico Number Analyzed 98 participants 98 participants 98 participants 294 participants
27 21 21 69
Bulgaria Number Analyzed 98 participants 98 participants 98 participants 294 participants
4 5 4 13
Bosnia and Herzegovina Number Analyzed 98 participants 98 participants 98 participants 294 participants
4 3 1 7
Germany Number Analyzed 98 participants 98 participants 98 participants 294 participants
2 3 2 8
India Number Analyzed 98 participants 98 participants 98 participants 294 participants
13 16 17 46
Spain Number Analyzed 98 participants 98 participants 98 participants 294 participants
9 12 12 33
Disease duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 98 participants 98 participants 294 participants
9.8  (6.73) 11.2  (7.72) 9.3  (7.10) 10.1  (7.22)
C-reactive protein   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 98 participants 98 participants 98 participants 294 participants
19.5  (28.99) 15.3  (20.63) 16.2  (17.91) 17.0  (2.99)
[1]
Measure Description:

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.

Erythrocyte sedimentation rate   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm/hr
Number Analyzed 97 participants 97 participants 97 participants 291 participants
51.0  (26.58) 47.5  (22.87) 51.5  (23.35) 50.0  (24.31)
[1]
Measure Analysis Population Description: Results were not available for 1 participant in each treatment arm
Swollen Joint Count (SJC66)   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 98 participants 97 participants 98 participants 293 participants
15.2  (7.97) 15.2  (7.01) 13.0  (6.19) 14.5  (7.14)
[1]
Measure Analysis Population Description: Results were not available for 1 participant in the MabThera treatment arm
Tender Joint Count (TJC68)   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 98 participants 97 participants 98 participants 293 participants
21.7  (11.08) 22.6  (13.66) 20.0  (10.84) 21.4  (11.93)
[1]
Measure Analysis Population Description: Results were not available for 1 participant in the MabThera treatment arm
Patient Global Assessments Visual Analogue Scale (VAS) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 97 participants 97 participants 97 participants 291 participants
68.9  (15.87) 67.6  (17.53) 70.8  (17.04) 69.1  (16.82)
[1]
Measure Description: Patients 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.
[2]
Measure Analysis Population Description: Results were not available for 1 participant in each treatment arm
Physician Global Assessment VAS Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 97 participants 97 participants 98 participants 292 participants
71.0  (14.3) 69.4  (15.9) 69.8  (14.32) 70.1  (14.51)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: 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   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 98 participants 98 participants 97 participants 293 participants
67.0  (18.71) 68.8  (20.02) 70.7  (19.06) 68.8  (19.27)
[1]
Measure Description: Patients assessment of pain (assessed on 1 to 100 mm Visual Analog Scale [VAS]) where 0 = no pain and 100 = severe pain.
[2]
Measure Analysis Population Description: Results were not available for 1 participant in the Rituxan treatment arm
Health Assessment Questionnaire Disability Index (HAQ-DI) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 98 participants 98 participants 97 participants 293 participants
1.7  (0.57) 1.7  (0.64) 1.6  (0.64) 1.7  (0.62)
[1]
Measure Description:

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.

[2]
Measure Analysis Population Description: 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(   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 98 participants 97 participants 98 participants 293 participants
5.28  (0.890) 5.29  (0.807) 5.17  (0833) 5.25  (0.843)
[1]
Measure Description: Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) consisted of tender joint counts (TJC), swollen joint counts (SJC) & C-reactive protein (CRP) blood levels. Total DAS28-CRPscores 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.
[2]
Measure Analysis Population Description: 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)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 96 participants 96 participants 96 participants 288 participants
6.54  (0.844) 6.53  (0.781) 6.48  (0.758) 6.52  (0.793)
[1]
Measure Description:

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 represented 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.

.

[2]
Measure Analysis Population Description: Results were not available for 2 participants in each treatment arm
Anti-drug Antibody (ADA) Status Positive   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 98 participants 96 participants 292 participants
2
   2.0%
1
   1.0%
4
   4.2%
7
   2.4%
[1]
Measure Analysis Population Description: Results were not available for 2 participants in the Rituxan arm
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 98 participants 98 participants 97 participants 293 participants
162.6  (9.29) 161.3  (8.79) 163.3  (8.37) 162.4  (8.83)
[1]
Measure Analysis Population Description: Results were not available for 1 participant in the Rituxan treatment arm
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 98 participants 98 participants 98 participants 294 participants
73.0  (17.62) 71.9  (16.94) 71.6  (17.99) 72.2  (17.47)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 98 participants 98 participants 97 participants 293 participants
27.5  (5.48) 27.5  (5.46) 26.7  (5.95) 27.2  (5.63)
[1]
Measure Analysis Population Description: Results were not available for 1 participant in the Rituxan treatment arm
1.Primary Outcome
Title Area Under the Concentration Time Cure From Time 0 to Last Quantifiable Concentration (AUC0-t)
Hide Description 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 79 70 76
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
144500
(34.2%)
151600
(33.2%)
154600
(35.6%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ration
Estimated Value 95.33
Confidence Interval (2-Sided) 90%
87.07 to 104.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 93.43
Confidence Interval (2-Sided) 90%
85.54 to 102.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 98.06
Confidence Interval (2-Sided) 90%
89.49 to 107.45
Estimation Comments [Not Specified]
2.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC0-∞)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 93 91 91
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
152300
(34.6%)
161900
(32.2%)
161300
(33.3%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 94.07
Confidence Interval (2-Sided) 90%
86.91 to 101.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ration
Estimated Value 94.39
Confidence Interval (2-Sided) 90%
87.21 to 102.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 100.35
Confidence Interval (2-Sided) 90%
92.68 to 108.65
Estimation Comments [Not Specified]
3.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC0-D15)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 91 88 83
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
42950
(26.7%)
44600
(25.6%)
43540
(24.1%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 96.31
Confidence Interval (2-Sided) 90%
90.52 to 102.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 98.65
Confidence Interval (2-Sided) 90%
92.64 to 105.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 102.43
Confidence Interval (2-Sided) 90%
96.14 to 109.14
Estimation Comments [Not Specified]
4.Primary Outcome
Title Peak Plasma Concentration (Cmax) After Day 15 Infusion
Hide Description Pharmacokinetic endpoint: Maximum Plasma Concentration (Cmax) after Day 15 infusion (Dose 2)
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 94 93 93
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
406.0
(28.3%)
427.7
(28.3%)
411.1
(24.5%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 94.93
Confidence Interval (2-Sided) 90%
89.03 to 101.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 98.75
Confidence Interval (2-Sided) 90%
92.61 to 105.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 104.03
Confidence Interval (2-Sided) 90%
97.54 to 110.95
Estimation Comments [Not Specified]
5.Primary Outcome
Title Trough Concentration (Ctrough) Before the Second Infusion on Day 15
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 83 81 77
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
60.35
(40.3%)
67.75
(36.2%)
58.84
(97.9%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 89.08
Confidence Interval (2-Sided) 90%
77.20 to 102.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 102.56
Confidence Interval (2-Sided) 90%
88.72 to 118.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment
Type of Statistical Test Equivalence
Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons
Method of Estimation Estimation Parameter GLS Mean Ratio
Estimated Value 115.13
Confidence Interval (2-Sided) 90%
99.51 to 133.21
Estimation Comments [Not Specified]
6.Primary Outcome
Title Change From Baseline in DAS28-CRP at Week 24
Hide Description

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.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 91 87 85
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.991  (1.1735) -0.832  (0.8483) -0.861  (0.9488)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Least square means and confidence intervals (CIs) were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only
Type of Statistical Test Equivalence
Comments The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of [-0.6,0.6]
Statistical Test of Hypothesis P-Value 0.2402
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.422 to 0.106
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.134
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only
Type of Statistical Test Equivalence
Comments The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of [-0.6,0.6]
Statistical Test of Hypothesis P-Value 0.1346
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.469 to 0.063
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.135
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only
Type of Statistical Test Equivalence
Comments The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of [-0.6,0.6]
Statistical Test of Hypothesis P-Value 0.7429
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.314 to 0.224
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.137
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Area Under the Concentration Time Curve Week 2 to Week 24 (AUC(w2-24)
Hide Description Pharmacokinetic endpoint: Area under the concentration time curve week 2 to week 24 (AUC(w2-24) calculated by linear up/log down trapezoidal summation.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 64 61 65
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
107300
(41.1%)
109200
(40.0%)
116000
(40.2%)
8.Secondary Outcome
Title Area Under the Concentration Time Curve Day 0 to Week 12 (AUC(0-w12))
Hide Description Pharmacokinetic endpoint: Area under the concentration time curve Day 0 to Week 12 calculated by linear up/log down trapezoidal summation.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 93 89 92
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
148500
(33.1%)
157400
(30.3%)
155900
(33.1%)
9.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) (Dose 1)
Hide Description Pharmacokinetic endpoint: Maximum plasma concentration over the first dosing interval obtained directly from the observed concentration versus time data.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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)..
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 93 92 91
Median (Inter-Quartile Range)
Unit of Measure: Hours
5.167
(3.00 to 6.50)
5.167
(3.00 to 358.75)
4.500
(3.00 to 6.75)
10.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) (Dose 2)
Hide Description Time of maximum concentration postinfusion over the second dosing interval, obtained directly from the observed concentration versus time data.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 94 93 93
Median (Inter-Quartile Range)
Unit of Measure: Hours
4.167
(2.92 to 5.50)
4.167
(0.00 to 48.08)
4.250
(2.92 to 23.50)
11.Secondary Outcome
Title Apparent Terminal Rate Constant (λz)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 93 91 92
Mean (Standard Deviation)
Unit of Measure: 1/hr
0.002358  (0.00061132) 0.002283  (0.00067311) 0.002240  (0.00059435)
12.Secondary Outcome
Title Systemic Clearance (CL)
Hide Description Pharmacokinetic endpoint: Systemic clearance (CL) over the first dosing period calculated as dose (first + second dose) divided by AUC(0-∞).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 93 91 91
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/day
0.01314
(34.6%)
0.01235
(29.0%)
0.01240
(33.3%)
13.Secondary Outcome
Title Volume of Distribution (VD)
Hide Description Pharmacokinetic endpoint: Volume of distribution (VD) over the first dosing period calculated as dose (first + second dose) divided by [λz AUC(0-∞)]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 93 91 91
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Litres (L)
5.757
(28.0%)
5.635
(23.6%)
5.727
(22.9%)
14.Secondary Outcome
Title Terminal Half-life (T1/2)
Hide Description Pharmacokinetic endpoint: Terminal half-life determined as ln2/λz.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 93 91 92
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
303.7
(26.1%)
316.1
(29.0%)
319.7
(26.2%)
15.Secondary Outcome
Title Change From Baseline in DAS28-CRP at Weeks 8, 16, 36 and 52
Hide Description

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.

Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 97 98
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 1 (Baseline) Number Analyzed 98 participants 97 participants 98 participants
5.282  (0.8899) 5.288  (0.8073) 5.170  (0.8326)
Week 8 Number Analyzed 93 participants 93 participants 93 participants
4.405  (1.0189) 4.324  (1.1132) 4.251  (1.1392)
Week 16 Number Analyzed 93 participants 93 participants 92 participants
4.001  (1.1116) 4.155  (0.9750) 4.100  (1.0044)
Week 24 Number Analyzed 91 participants 88 participants 85 participants
4.300  (1.0331) 4.463  (1.0648) 4.443  (0.9774)
Week 36 Number Analyzed 90 participants 83 participants 84 participants
3.552  (1.1452) 3.823  (0.9290) 3.716  (1.0684)
Week 52 (End of Study( Number Analyzed 92 participants 88 participants 87 participants
3.660  (1.2636) 3.754  (1.3037) 3.518  (1.1276)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 (EOS). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6068
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.428 to 0.250
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.172
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 (EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5990
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.249 to 0.430
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.172
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Week 53 (EOS) MabThera vs Rituxan. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3053
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.165 to 0.532
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.175
Estimation Comments [Not Specified]
16.Secondary Outcome
Title American Collage of Rheumatology 20% Response Criteria (ACR20) Response Rates at Weeks 8, 16, 24, 36 and 52
Hide Description

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).

Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
ACR20 Week 8 Number Analyzed 95 participants 93 participants 92 participants
39
(31.70 to 51.10)
33
(26.51 to 45.61)
44
(37.91 to 57.91)
ACR20 Week 16 Number Analyzed 94 participants 92 participants 91 participants
50
(43.18 to 62.95)
54
(48.48 to 68.21)
53
(47.98 to 67.84)
ACR20 Week 24 Number Analyzed 92 participants 87 participants 86 participants
36
(28.79 to 49.35)
31
(26.37 to 46.11)
34
(29.86 to 50.10)
ACR20 Week 36 Number Analyzed 90 participants 82 participants 83 participants
63
(59.87 to 78.49)
47
(46.52 to 67.46)
58
(58.00 to 78.69)
ACR20 Week 52 (EOS) Number Analyzed 94 participants 90 participants 89 participants
60
(53.75 to 72.82)
49
(44.18 to 64.34)
59
(55.98 to 75.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
-4.74 to 23.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-15.95 to 11.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value -11.8
Confidence Interval (2-Sided) 95%
-25.47 to 2.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.26
Estimation Comments [Not Specified]
17.Secondary Outcome
Title 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
Hide Description

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).

Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
ACR50 Week 8 Number Analyzed 95 participants 93 participants 93 participants
13
(8.17 to 22.02)
11
(6.73 to 19.95)
14
(9.29 to 23.94)
ACR70 Week 8 Number Analyzed 95 participants 93 participants 92 participants
2
(0.58 to 7.35)
2
(0.59 to 7.51)
2
(0.60 to 7.58)
ACR50 Week 16 Number Analyzed 94 participants 92 participants 91 participants
17
(11.61 to 27.07)
16
(11.00 to 26.40)
14
(9.39 to 24.18)
ACR70 Week 16 Number Analyzed 94 participants 92 participants 91 participants
9
(5.12 to 17.20)
4
(1.70 to 10.65)
5
(2.37 to 12.22)
ACR50 Week 24 Number Analyzed 92 participants 87 participants 86 participants
15
(10.14 to 25.17)
8
(4.73 to 17.11)
5
(2.51 to 12.90)
ACR70 Week 24 Number Analyzed 92 participants 87 participants 86 participants
8
(4.47 to 16.23)
2
(0.63 to 8.00)
3
(1.19 to 9.76)
ACR50 Week 36 Number Analyzed 90 participants 82 participants 83 participants
37
(31.51 to 51.44)
19
(15.37 to 33.38)
25
(21.31 to 40.69)
ACR70 Week 36 Number Analyzed 90 participants 82 participants 83 participants
19
(13.95 to 30.63)
6
(3.40 to 15.06)
12
(8.47 to 23.59)
ACR50 Week 52 (EOS) Number Analyzed 94 participants 90 participants 89 participants
35
(28.14 to 47.33)
25
(19.58 to 37.80)
30
(24.74 to 44.02)
ACR70 Week 52 (EOS) Number Analyzed 94 participants 90 participants 89 participants
23
(16.89 to 34.05)
13
(8.64 to 23.16)
17
(12.28 to 28.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments ACR20 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value 9.5
Confidence Interval (2-Sided) 95%
-4.07 to 22.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
-10.22 to 17.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value -5.9
Confidence Interval (2-Sided) 95%
-19.10 to 7.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value 10.0
Confidence Interval (2-Sided) 95%
-1.52 to 21.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-6.69 to 17.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value -4.7
Confidence Interval (2-Sided) 92%
-15.68 to 6.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.58
Estimation Comments [Not Specified]
18.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Least Squares Mean (Standard Deviation)
Unit of Measure: Joints
Swollen Joint Count Day 1 Number Analyzed 98 participants 97 participants 98 participants
15.2  (7.97) 15.2  (15.2) 13.0  (6.19)
Swollen Joint Count Week 8 Number Analyzed 95 participants 94 participants 93 participants
8.6  (7.11) 8.4  (6.62) 7.7  (5.92)
Swollen Joint Count 16 Number Analyzed 94 participants 93 participants 92 participants
6.5  (4.86) 7.8  (7.20) 7.0  (5.37)
Swollen Joint Count 24 Number Analyzed 92 participants 88 participants 87 participants
8.5  (5.13) 10.0  (5.85) 10.0  (6.19)
Swollen Joint Count 36 Number Analyzed 90 participants 83 participants 85 participants
4.8  (6.21) 5.4  (5.72) 5.7  (5.49)
Swollen Joint Count Week 52 (EOS) Number Analyzed 94 participants 91 participants 90 participants
5.2  (6.53) 6.5  (9.46) 4.6  (5.04)
Tender Joint Count Day 1 Number Analyzed 98 participants 97 participants 98 participants
21.7  (11.08) 22.6  (13.66) 20.0  (10.84)
Tender Joint Score Week 8 Number Analyzed 95 participants 94 participants 93 participants
13.9  (9.94) 14.0  (9.94) 13.5  (10.69)
Tender Joint Count Week 16 Number Analyzed 94 participants 93 participants 92 participants
11.1  (10.24) 12.5  (8.36) 11.8  (9.09)
Tender Joint Score Week 24 Number Analyzed 92 participants 88 participants 87 participants
13.6  (9.79) 15.6  (11.94) 15.2  (11.62)
Tender Joint Score Week 36 Number Analyzed 90 participants 83 participants 85 participants
8.3  (9.10) 10.9  (10.68) 9.6  (10.81)
Tender Joint Score Week 52 (EOS) Number Analyzed 94 participants 91 participants 90 participants
9.3  (9.34) 11.9  (15.18) 9.4  (11.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1997
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -1.28
Confidence Interval (2-Sided) 95%
-3.230 to 0.671
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.991
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9098
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-2.074 to 1.848
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.996
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2480
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
-0.817 to 3.150
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.008
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Tender Joint Count (TJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1931
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -1.96
Confidence Interval (2-Sided) 95%
-4.909 to 0.996
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.500
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value -0.77
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-3.722 to 2.184
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.500
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4352
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
-1.805 to 4.180
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.520
Estimation Comments [Not Specified]
19.Secondary Outcome
Title 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])
Hide Description 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.
Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Disease Activty iDay 1 Number Analyzed 97 participants 97 participants 98 participants
71.0  (14.30) 69.4  (15.00) 69.8  (14.32)
Disease Activity Week 8 Number Analyzed 95 participants 93 participants 91 participants
45.6  (20.75) 43.2  (23.86) 44.6  (23.28)
Disease Activtiy Week 16 Number Analyzed 93 participants 93 participants 91 participants
39.2  (20.94) 39.0  (20.97) 42.3  (20.89)
Disease Activity Week 24 Number Analyzed 91 participants 87 participants 87 participants
47.9  (22.28) 47.8  (20.25) 49.0  (22.45)
Disease Activtiy Week 36 Number Analyzed 90 participants 83 participants 86 participants
30.3  (21.56) 36.3  (21.71) 31.4  (20.69)
Disease Activity Week 52 (EOS) Number Analyzed 94 participants 91 participants 90 participants
31.1  (21.67) 35.1  (23.49) 31.2  (22.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -4.16
Confidence Interval (2-Sided) 95%
-10.541 to 2.226
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.242
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value -0.39
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-6.771 to 5.994
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.242
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2498
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 3.77
Confidence Interval (2-Sided) 95%
-2.665 to 10.204
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.268
Estimation Comments [Not Specified]
20.Secondary Outcome
Title 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])
Hide Description 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.
Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Least Squares Mean (Standard Deviation)
Unit of Measure: score on a scale
Assessment of Pain Day 1 Number Analyzed 98 participants 98 participants 97 participants
67.0  (18.71) 68.8  (20.02) 68.8  (19.27)
Assessment of Pain Week 8 Number Analyzed 95 participants 93 participants 92 participants
48.4  (22.79) 50.4  (22.40) 47.9  (23.03)
Assessment of Pain Week 16 Number Analyzed 94 participants 91 participants 92 participants
42.7  (23.34) 44.6  (20.91) 44.4  (22.91)
Assessment of Pain Week 24 Number Analyzed 92 participants 88 participants 86 participants
49.3  (24.15) 51.6  (21.44) 51.8  (23.58)
Assessment of Pain Week 36 Number Analyzed 90 participants 83 participants 84 participants
36.8  (24.56) 44.9  (23.78) 41.6  (23.46)
Assessment of Pain Week 52 (EOS) Number Analyzed 94 participants 91 participants 91 participants
41.2  (24.34) 43.2  (24.42) 44.5  (26.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7322
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -1.23
Confidence Interval (2-Sided) 95%
-8.0302 to 5.841
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.592
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5418
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -2.21
Confidence Interval (2-Sided) 95%
-9.347 to 4.920
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.623
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7869
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.98
Confidence Interval (2-Sided) 95%
-8.136 to 6.169
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.633
Estimation Comments [Not Specified]
21.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Least Squares Mean (Standard Deviation)
Unit of Measure: score on a scale
Disease activity Day 1 Number Analyzed 97 participants 97 participants 97 participants
68.9  (15.87) 67.6  (17.53) 70.8  (17.04)
Disease activity Week 8 Number Analyzed 95 participants 94 participants 93 participants
46.9  (22.57) 49.1  (22.98) 48.5  (22.93)
Disease activity Week 16 Number Analyzed 94 participants 93 participants 92 participants
43.9  (21.47) 44.4  (21.63) 44.2  (22.82)
Disease activity Week 24 Number Analyzed 92 participants 88 participants 86 participants
50.8  (23.16) 51.1  (20.49) 52.3  (21.90)
Disease activity Week 36 Number Analyzed 90 participants 82 participants 85 participants
35.7  (22.63) 42.7  (22.54) 42.5  (23.70)
Disease activity Week 52 (EOS) Number Analyzed 95 participants 91 participants 91 participants
41.4  (23.02) 42.4  (24.10) 43.1  (23.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7097
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -1.28
Confidence Interval (2-Sided) 95%
-8.062 to 5.496
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.443
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6683
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -1.48
Confidence Interval (2-Sided) 95%
-8.280 to 5.317
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.453
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9548
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-7.078 to 6.682
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.494
Estimation Comments [Not Specified]
22.Secondary Outcome
Title 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])
Hide Description

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.

Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Least Squares Mean (Standard Deviation)
Unit of Measure: score on a scale
HAQ-DI Day 1 Number Analyzed 98 participants 98 participants 97 participants
1.610  (0.5728) 1.605  (0.6567) 1.585  (0.6421)
HAQ-DI Week 8 Number Analyzed 95 participants 94 participants 93 participants
1.168  (0.6318) 1.314  (0.6919) 1.176  (0.6398)
HAQ-DI Week 16 Number Analyzed 94 participants 93 participants 92 participants
1.129  (0.5775) 1.246  (0.6394) 1.152  (0.6668)
HAQ-DI Week 24 Number Analyzed 92 participants 88 participants 86 participants
1.209  (0.6071) 1.335  (0.6381) 1.294  (0.6594)
HAQ-DI Week 36 Number Analyzed 90 participants 83 participants 84 participants
0.994  (0.6220) 1.182  (0.6883) 1.061  (0.6247)
HAQ-DI Week 52 (EOS) Number Analyzed 94 participants 91 participants 91 participants
1.027  (0.6208) 1.207  (0.7025) 1.190  (0.7116)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0505
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.339 to 0.000
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.086
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1141
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.307 to 0.033
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.086
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Week 52 (EOS) HAQ-DI )0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7111
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.139 to 0.204
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.087
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: C-reactive Protein (CRP) Level
Hide Description

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.

Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Least Squares Mean (Standard Deviation)
Unit of Measure: Mg/L
CRP Day 1 Number Analyzed 98 participants 98 participants 98 participants
19.5  (28.99) 15.3  (20.63) 16.2  (17.91)
CRP Week 8 Number Analyzed 93 participants 93 participants 93 participants
12.5  (15.78) 12.3  (20.29) 10.4  (12.78)
CRP Week 16 Number Analyzed 93 participants 93 participants 92 participants
8.5  (11.78) 7.2  (9.02) 7.3  (6.90)
CRP Week 24 Number Analyzed 91 participants 88 participants 85 participants
9.5  (14.54) 8.3  (14.40) 7.9  (10.35)
CRP Week 36 Number Analyzed 90 participants 83 participants 85 participants
8.0  (20.33) 7.0  (10.38) 7.1  (9.72)
CRP Week 52 (EOS) Number Analyzed 92 participants 88 participants 88 participants
9.8  (14.14) 9.1  (14.93) 7.4  (11.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8183
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-4.113 to 3.253
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.871
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4186
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
-2.164 to 5.191
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.868
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3035
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 1.94
Confidence Interval (2-Sided) 95%
-1.768 to 5.655
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.885
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline DAS28-erythrocyte Sedimentation Rate (ESR) at Weeks 8, 16, 24, 36 and 52
Hide Description

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.

Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Mean (Standard Deviation)
Unit of Measure: score on a scale
DAS28-ESR Day 1 Number Analyzed 96 participants 96 participants 96 participants
6.537  (0.8440) 6.533  (.07810) 6.480  (0.7577)
DAS28-ESR Week 8 Number Analyzed 94 participants 92 participants 93 participants
5.330  (1.0649) 5.315  (1.2478) 5.235  (1.2578)
DAS28-ESR Week 16 Number Analyzed 94 participants 92 participants 92 participants
4.861  (1.1876) 5.059  (1.1682) 4.957  (1.1802)
DAS28-ESR Week 24 Number Analyzed 92 participants 87 participants 85 participants
5.216  (1.2510) 5.410  (1.2344) 5.432  (1.1891)
DAS28-ESR Week 36 Number Analyzed 90 participants 80 participants 80 participants
4.319  (1.2798) 4.689  (1.0077) 4.499  (1.1980)
DAS28-ESR Week 52 (EOS) Number Analyzed 92 participants 86 participants 82 participants
4.435  (1.4375) 4.485  (1.4390) 4.391  (1.3947)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9249
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.375 to 0.413
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.200
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Measn Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.351 to 0.442
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.201
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8962
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Diference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.376 to 0.430
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.205
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Number of Participants With a Major Clinical Response (Continuous ACR70) for at Least 24 Weeks
Hide Description

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.

Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
Major Clinical Response Week 24 Number Analyzed 92 participants 86 participants 85 participants
1
(0.19 to 5.90)
0
(0.00 to 4.28)
0
(0.00 to 4.32)
Major Clinical Response Week 52 (EOS) Number Analyzed 89 participants 81 participants 80 participants
2
(0.62 to 7.83)
0
(0.00 to 4.53)
1
(0.22 to 6.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
-2.56 to 7.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-4.74 to 6.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-6.75 to 3.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.24
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Number of Participants With a Clinical Remission Response (CRR) at Weeks 8, 16, 24, 36 and 52
Hide Description 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).
Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
CRR Week 8 Number Analyzed 93 participants 92 participants 91 participants
0
(0.00 to 3.97)
0
(0.00 to 4.01)
0
(0.00 to 4.05)
CRR Week 16 Number Analyzed 92 participants 93 participants 91 participants
0
(0.00 to 4.01)
1
(0.19 to 5.84)
0
(0.00 to 4.05)
CRR Week 24 Number Analyzed 90 participants 87 participants 84 participants
0
(0.00 to 4.09)
1
(0.20 to 6.23)
0
(0.00 to 4.37)
CRR Week 36 Number Analyzed 90 participants 82 participants 83 participants
2
(0.61 to 7.74)
0
(0.00 to 4.48)
1
(0.21 to 6.51)
CRR Week 52 (EOS) Number Analyzed 92 participants 88 participants 86 participants
1
(0.19 to 5.90)
2
(0.63 to 7.91)
2
(0.64 to 8.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-6.9 to 3.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-7.07 to 3.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MabThera, Rituxan
Comments Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Differnce (%)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-6.05 to 5.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.27
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52
Hide Description 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.
Time Frame Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 98 98 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
Week 8 Good Number Analyzed 93 participants 92 participants 93 participants
12
(7.54 to 21.21)
14
(9.29 to 23.94)
12
(7.54 to 21.21)
Week 8 Good or Moderate Number Analyzed 93 participants 92 participants 93 participants
30
(23.62 to 42.30)
33
(26.82 to 46.05)
33
(26.51 to 45.61)
Week 16 Good Number Analyzed 93 participants 92 participants 92 participants
20
(14.38 to 30.90)
12
(7.62 to 21.43)
13
(8.45 to 22.69)
Week 16 Good or Moderate Number Analyzed 93 participants 92 participants 92 participants
44
(37.47 to 57.36)
42
(35.85 to 55.80)
33
(26.82 to 46.05)
Week 24 Good Number Analyzed 91 participants 87 participants 85 participants
12
(7.71 to 21.65)
7
(3.95 to 15.69)
7
(4.05 to 16.04)
Week 24 Good or Moderate Number Analyzed 91 participants 87 participants 85 participants
30
(24.17 to 43.14)
26
(21.28 to 40.19)
23
(18.76 to 37.34)
Week 36 Good Number Analyzed 90 participants 82 participants 84 participants
27
(21.51 to 40.13)
15
(11.41 to 28.01)
27
(23.13 to 42.72)
Week 36 Good or Moderate Number Analyzed 90 participants 82 participants 84 participants
58
(54.15 to 73.56)
50
(50.00 to 70.82)
54
(53.62 to 73.70)
Week 52 (EOS) Good Number Analyzed 92 participants 87 participants 87 participants
34
(27.80 to 47.16)
31
(26.37 to 46.11)
32
(27.41 to 47.27)
Week 52 (EOS) Good or Moderate Number Analyzed 92 participants 50 participants 87 participants
59
(53.95 to 73.18)
50
(46.98 to 67.33)
63
(62.23 to 80.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
Comments Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-12.59 to 15.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Difference (%)
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-13.75 to 14.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SAIT101, Rituxan
Comments Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (%)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-15.14 to 12.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.29
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels)
Hide Description 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)
Time Frame Baseline (Day 1) and Weeks 8, 16, 24, 36 and 52 (EOS)
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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).
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 95 96 93
Mean (Standard Deviation)
Unit of Measure: Mg/dL
IgG Screening Number Analyzed 95 participants 96 participants 93 participants
1231.0  (299.36) 1230.1  (365.54) 1203.4  (373.29)
IgG Week 8 Number Analyzed 94 participants 94 participants 91 participants
1108.0  (242.20) 1080.6  (279.75) 1038.5  (290.01)
IgG Week 16 Number Analyzed 91 participants 93 participants 91 participants
1105.2  (232.51) 1075.7  (277.51) 1038.5  (290.01)
IgG Week 24 Number Analyzed 91 participants 83 participants 86 participants
1114.6  (251.78) 1077.2  (265.55) 1023.2  (278.70)
IgG Week 36 Number Analyzed 89 participants 86 participants 84 participants
1076.6  (246.62) 1060.9  (305.12) 976.6  (249.11)
IgG Week 52 (EOS) Number Analyzed 89 participants 86 participants 87 participants
1102.0  (274.44) 1081.1  (285.13) 999.9  (232.03)
IgM Screening Number Analyzed 95 participants 96 participants 93 participants
164.3  (76.07) 167.9  (100.16) 159.0  (81.36)
IgM Week 8 Number Analyzed 94 participants 94 participants 91 participants
137.5  (71.38) 132.6  (83.58) 128.9  (68.50)
IgM Week 16 Number Analyzed 91 participants 94 participants 91 participants
123.7  (61.08) 124.9  (85.71) 117.0  (60.44)
IgM Week 24 Number Analyzed 91 participants 86 participants 86 participants
123.3  (62.37) 117.1  (80.96) 109.9  (73.11)
IgM Week 36 Number Analyzed 89 participants 83 participants 84 participants
111.7  (56.89) 108.0  (77.79) 99.7  (56.38)
IgM Week 52 (EOS) Number Analyzed 89 participants 86 participants 87 participants
109.6  (56.80) 107.6  (77.00) 95.2  (52.57)
IgA Screening Number Analyzed 95 participants 96 participants 93 participants
321.1  (269.22) 283.4  (134.80) 342.9  (153.24)
IgA Week 8 Number Analyzed 93 participants 94 participants 93 participants
293.6  (176.04) 264.4  (121.41) 316.5  (146.15)
IgA Week 16 Number Analyzed 91 participants 93 participants 91 participants
301.8  (204.14) 253.0  (111.58) 312.7  (151.87)
IgA Week 24 Number Analyzed 91 participants 86 participants 91 participants
279.8  (119.87) 263.0  (121.15) 307.7  (147.92)
IgA Week 36 Number Analyzed 89 participants 83 participants 89 participants
283.8  (204.12) 259.2  (116.55) 297.1  (146.85)
IgA Week 52 Number Analyzed 89 participants 83 participants 89 participants
269.4  (116.74) 254.7  (115.38) 297.8  (138.63)
29.Other Pre-specified Outcome
Title Pharmacodynamic Endpoint: Depletion of B-lymphocyte Antigen CD19 (CD19+) B-cell Count up to Week 24
Hide Description Pharmacodynamic endpoint: proportion of participants (n) with depletion of CD19+ B-cell count up to week 24 (Pharmacodynamic analysis set).
Time Frame 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.
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Pharmacokinetic data set
Arm/Group Title SAIT101 MabThera Rituxan
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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,
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.
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
Overall Number of Participants Analyzed 95 96 94
Measure Type: Number
Unit of Measure: participants
45 46 50
30.Other Pre-specified Outcome
Title Pharmacodynamic Endpoint: Time Needed to CD19+ B-cell Depletion
Hide Description 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).
Time Frame 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.
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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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 93 93 90
Mean (Standard Deviation)
Unit of Measure: Days
1.524  (2.6274) 2.847  (9.1286) 2.223  (9.0833)
31.Other Pre-specified Outcome
Title Pharmacodynamic Endpoint: Duration of CD19+ B-cell Depletion
Hide Description Duration of CD19+ B-cell depletion (only participants that returned to non-depletion at or before week 24 were included)
Time Frame 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.
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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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 36 26 21
Mean (Standard Deviation)
Unit of Measure: Days
78.444  (77.5290) 85.856  (73.4460) 77.290  (72.0557)
32.Other Pre-specified Outcome
Title Pharmacodynamic Endpoint: Number of Participants With CD19+ B-cell Count Recover Versus Baseline
Hide Description 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).
Time Frame 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.
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Pharmacodynamic Analysis Set
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 93 93 90
Measure Type: Count of Participants
Unit of Measure: Participants
5
   5.4%
4
   4.3%
3
   3.3%
33.Other Pre-specified Outcome
Title Pharmaco Endpoint: Area Under the Concentration Time Curve of CD19 B-cell Count Change at Day 15 and Week 24
Hide Description 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
Time Frame 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.
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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.
Arm/Group Title SAIT101 MabThera Rituxan
Hide Arm/Group Description:
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,
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.
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
Overall Number of Participants Analyzed 72 76 73
Least Squares Mean (95% Confidence Interval)
Unit of Measure: cells*day/µL)
AUEC(0-d15) Number Analyzed 72 participants 76 participants 73 participants
-2650.0
(-2786.0 to -2513.9)
-2672.1
(-2804.9 to -2539.3)
-2719.4
(-2855.3 to 2583.6)
AUEC(0-w24) Number Analyzed 56 participants 56 participants 52 participants
-32707.6
(-33128.1 to -32287.1)
-33018.3
(-33440.4 to -32596.2)
-33003.7
(-33442.8 to -32564.6)