PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT02819726 |
Recruitment Status :
Completed
First Posted : June 30, 2016
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
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Study Type | Interventional |
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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) |
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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 | 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
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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.
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Arm/Group Title | SAIT101 | MabThera | Rituxan | Total | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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18-60 years | Number Analyzed | 98 participants | 98 participants | 98 participants | 294 participants |
76 77.6%
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75 76.5%
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71 72.4%
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222 75.5%
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>60 years | Number Analyzed | 98 participants | 98 participants | 98 participants | 294 participants |
22 22.4%
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23 23.5%
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27 27.6%
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72 24.5%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 98 participants | 98 participants | 98 participants | 294 participants | |
Female |
79 80.6%
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81 82.7%
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80 81.6%
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240 81.6%
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Male |
19 19.4%
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17 17.3%
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18 18.4%
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54 18.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 98 participants | 98 participants | 98 participants | 294 participants | |
Hispanic or Latino |
30 30.6%
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30 30.6%
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29 29.6%
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89 30.3%
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Not Hispanic or Latino |
68 69.4%
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68 69.4%
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69 70.4%
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205 69.7%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 98 participants | 98 participants | 98 participants | 294 participants | |
American Indian or Alaska Native |
24 24.5%
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20 20.4%
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21 21.4%
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65 22.1%
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Asian |
18 18.4%
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19 19.4%
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24 24.5%
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61 20.7%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
2 2.0%
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0 0.0%
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1 1.0%
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3 1.0%
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White |
52 53.1%
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56 57.1%
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52 53.1%
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160 54.4%
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More than one race |
2 2.0%
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3 3.1%
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0 0.0%
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5 1.7%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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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 |
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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 |
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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. |
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Erythrocyte sedimentation rate
[1] Mean (Standard Deviation) Unit of measure: Mm/hr |
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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
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Swollen Joint Count (SJC66)
[1] Mean (Standard Deviation) Unit of measure: Joints |
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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
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Tender Joint Count (TJC68)
[1] Mean (Standard Deviation) Unit of measure: Joints |
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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
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Patient Global Assessments Visual Analogue Scale (VAS) Score
[1] [2] Mean (Standard Deviation) Unit of measure: Units on a scale |
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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
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Physician Global Assessment VAS Score
[1] [2] Mean (Standard Deviation) Unit of measure: Units on a scale |
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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
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Patient Pain Assessment VAS Score
[1] [2] Mean (Standard Deviation) Unit of measure: Units on a scale |
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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
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Health Assessment Questionnaire Disability Index (HAQ-DI) Score
[1] [2] Mean (Standard Deviation) Unit of measure: Score |
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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
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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 |
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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
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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 |
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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
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Anti-drug Antibody (ADA) Status Positive
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 98 participants | 98 participants | 96 participants | 292 participants | |
2 2.0%
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1 1.0%
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4 4.2%
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7 2.4%
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[1]
Measure Analysis Population Description: Results were not available for 2 participants in the Rituxan arm
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Height
[1] Mean (Standard Deviation) Unit of measure: Cm |
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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
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Weight
Mean (Standard Deviation) Unit of measure: Kg |
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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 |
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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
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