Trial Outcomes & Findings for MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis (NCT NCT04512001)
NCT ID: NCT04512001
Last Updated: 2023-06-27
Results Overview
The DAS28-ESR is a measure of disease activity in 28 joints that consists of a composite numerical score of the following variables: Tender Joint Count (TJC), Swollen Joint Count (SJC), erythrocyte sedimentation rate (ESR) and Patient's Global Assessment of Disease Activity. The DAS28-ESR score was derived using the formula: DAS28-ESR = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.014\*GH + 0.70\*Ln(ESR), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the general health component of the DAS (i.e., Patient's Global Assessment of Disease Activity on a scale of 1 to 100 where 100 is maximal activity). Higher values mean a higher disease activity. The level of disease activity can be interpreted as: * Remission (score of \<2.6). * Low (score of ≤2.6 to \<3.2). * Moderate (score of ≤3.2 to ≤5.1). * High (score of \>5.1) A negative change from baseline indicates an improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
604 participants
Primary outcome timeframe
Baseline; Week 24
Results posted on
2023-06-27
Participant Flow
Participant milestones
| Measure |
Core Treatment Period: MSB11456
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456
Participants who received MSB11456 during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week for an additional 28-week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
Participants who received EU-approved RoActemra® during the core treatment period (Baseline to Week 24).
Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week for an additional 28-week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra®
Participants who received EU-approved RoActemra® during the core treatment period (Baseline to Week 24).
Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week for an additional 28-week during the extended treatment period (Week 24 to Week 52).
|
|---|---|---|---|---|---|
|
Week 0 to Week 24
STARTED
|
302
|
302
|
0
|
0
|
0
|
|
Week 0 to Week 24
Received Treatment
|
302
|
302
|
0
|
0
|
0
|
|
Week 0 to Week 24
COMPLETED
|
267
|
276
|
0
|
0
|
0
|
|
Week 0 to Week 24
NOT COMPLETED
|
35
|
26
|
0
|
0
|
0
|
|
Week 24 to Week 63
STARTED
|
0
|
0
|
267
|
139
|
137
|
|
Week 24 to Week 63
Received Treatment
|
0
|
0
|
266
|
139
|
136
|
|
Week 24 to Week 63
COMPLETED
|
0
|
0
|
244
|
123
|
122
|
|
Week 24 to Week 63
NOT COMPLETED
|
0
|
0
|
23
|
16
|
15
|
Reasons for withdrawal
| Measure |
Core Treatment Period: MSB11456
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456
Participants who received MSB11456 during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week for an additional 28-week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
Participants who received EU-approved RoActemra® during the core treatment period (Baseline to Week 24).
Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week for an additional 28-week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra®
Participants who received EU-approved RoActemra® during the core treatment period (Baseline to Week 24).
Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week for an additional 28-week during the extended treatment period (Week 24 to Week 52).
|
|---|---|---|---|---|---|
|
Week 0 to Week 24
Adverse Event
|
14
|
10
|
0
|
0
|
0
|
|
Week 0 to Week 24
Death
|
0
|
2
|
0
|
0
|
0
|
|
Week 0 to Week 24
Withdrawal by Subject
|
16
|
9
|
0
|
0
|
0
|
|
Week 0 to Week 24
Discontinued treatment prior to Week 24
|
4
|
4
|
0
|
0
|
0
|
|
Week 0 to Week 24
Withdrawal By Sponsor's Decision
|
1
|
0
|
0
|
0
|
0
|
|
Week 0 to Week 24
Subject Did Not Meet Eligibility But Was Randomized
|
0
|
1
|
0
|
0
|
0
|
|
Week 24 to Week 63
Adverse Event
|
0
|
0
|
13
|
8
|
6
|
|
Week 24 to Week 63
Lost to Follow-up
|
0
|
0
|
1
|
1
|
1
|
|
Week 24 to Week 63
Death
|
0
|
0
|
0
|
1
|
1
|
|
Week 24 to Week 63
Withdrawal by Subject
|
0
|
0
|
6
|
4
|
6
|
|
Week 24 to Week 63
Miscellaneous
|
0
|
0
|
3
|
2
|
1
|
Baseline Characteristics
MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Core Treatment Period: MSB11456
n=302 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
n=302 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Total
n=604 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
302 Participants
n=99 Participants
|
302 Participants
n=107 Participants
|
604 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
19 participants
n=99 Participants
|
23 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
19 participants
n=99 Participants
|
25 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
156 participants
n=99 Participants
|
147 participants
n=107 Participants
|
303 participants
n=206 Participants
|
|
Region of Enrollment
Moldova
|
14 participants
n=99 Participants
|
9 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Region of Enrollment
Georgia
|
43 participants
n=99 Participants
|
51 participants
n=107 Participants
|
94 participants
n=206 Participants
|
|
Region of Enrollment
Slovakia
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 12.72 • n=99 Participants
|
53.2 years
STANDARD_DEVIATION 11.33 • n=107 Participants
|
52.2 years
STANDARD_DEVIATION 12.08 • n=206 Participants
|
|
Sex: Female, Male
Female
|
250 Participants
n=99 Participants
|
248 Participants
n=107 Participants
|
498 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
300 Participants
n=99 Participants
|
300 Participants
n=107 Participants
|
600 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
18 participants
n=99 Participants
|
16 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Region of Enrollment
Serbia
|
7 participants
n=99 Participants
|
11 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
21 participants
n=99 Participants
|
19 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 24Population: ITT Analysis Set: includes all randomized participants.
The DAS28-ESR is a measure of disease activity in 28 joints that consists of a composite numerical score of the following variables: Tender Joint Count (TJC), Swollen Joint Count (SJC), erythrocyte sedimentation rate (ESR) and Patient's Global Assessment of Disease Activity. The DAS28-ESR score was derived using the formula: DAS28-ESR = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.014\*GH + 0.70\*Ln(ESR), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the general health component of the DAS (i.e., Patient's Global Assessment of Disease Activity on a scale of 1 to 100 where 100 is maximal activity). Higher values mean a higher disease activity. The level of disease activity can be interpreted as: * Remission (score of \<2.6). * Low (score of ≤2.6 to \<3.2). * Moderate (score of ≤3.2 to ≤5.1). * High (score of \>5.1) A negative change from baseline indicates an improvement.
Outcome measures
| Measure |
Core Treatment Period: MSB11456
n=302 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
n=302 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra®
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
|
-3.53 score on a scale
Standard Error 0.106
|
-3.54 score on a scale
Standard Error 0.106
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16; Extended Period Baseline (Week 24), Week 30, Week 42, and Week 52Population: ITT Analysis Set: includes all randomized participants in either the Core Treatment period or the Extended Treatment period and who had a result at baseline and at each specific time point.
The DAS28-ESR is a measure of disease activity in 28 joints that consists of a composite numerical score of the following variables: TJC, SJC, ESR and Patient's Global Assessment of Disease Activity. The DAS28-ESR score was derived using the formula: DAS28-ESR = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.014\*GH + 0.70\*Ln(ESR), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the general health component of the DAS (i.e., Patient's Global Assessment of Disease Activity on a scale of 1 to 100 where 100 is maximal activity). Higher values mean a higher disease activity. The level of disease activity can be interpreted as: * Remission (score of \<2.6). * Low (score of ≤2.6 to \<3.2). * Moderate (score of ≤3.2 to ≤5.1). * High (score of \>5.1) A negative change from baseline indicates an improvement. For weeks 30, 42 and 52, the extended baseline (week 24) was used for the change in DAS28-ESR calculation.
Outcome measures
| Measure |
Core Treatment Period: MSB11456
n=302 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
n=302 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456
n=267 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
n=139 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra®
n=137 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 2
|
-1.24 score on a scale
Standard Deviation 1.022
|
-1.21 score on a scale
Standard Deviation 0.949
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 4
|
-1.96 score on a scale
Standard Deviation 1.184
|
-1.98 score on a scale
Standard Deviation 1.135
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 8
|
-2.75 score on a scale
Standard Deviation 1.220
|
-2.69 score on a scale
Standard Deviation 1.260
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 12
|
-3.13 score on a scale
Standard Deviation 1.249
|
-3.09 score on a scale
Standard Deviation 1.279
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 16
|
-3.41 score on a scale
Standard Deviation 1.288
|
-3.32 score on a scale
Standard Deviation 1.242
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 30
|
—
|
—
|
-0.16 score on a scale
Standard Deviation 0.801
|
-0.13 score on a scale
Standard Deviation 0.756
|
-0.02 score on a scale
Standard Deviation 0.863
|
|
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 42
|
—
|
—
|
-0.34 score on a scale
Standard Deviation 1.042
|
-0.08 score on a scale
Standard Deviation 1.026
|
-0.27 score on a scale
Standard Deviation 1.031
|
|
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 52
|
—
|
—
|
-0.42 score on a scale
Standard Deviation 1.185
|
-0.31 score on a scale
Standard Deviation 1.064
|
-0.37 score on a scale
Standard Deviation 1.086
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: ITT Analysis Set: includes all randomized participants.
ACR20 was defined as the number of participants with at least 20% improvement from baseline in number of tender and swollen joints (68/66 joint count), and at least 20% improvement from baseline in three or more of the 5 ACR Core Set measures: * Patient's Assessment of Arthritis Pain * Physical Function Assessment (Health Assessment Questionnaire-Disability Index) * Acute phase reactant level (erythrocyte sedimentation rate or C-reactive protein) * Patient's Global Assessment of Disease Activity and * Physician's Global Assessment of Disease Activity
Outcome measures
| Measure |
Core Treatment Period: MSB11456
n=302 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
n=302 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra®
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
|---|---|---|---|---|---|
|
Number of Participants With 20% Improvement in American College of Rheumatology (ACR20) Response
|
244 Participants
|
256 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to end of study, up to Week 63Population: Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra).
Outcome measures
| Measure |
Core Treatment Period: MSB11456
n=302 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
n=139 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456
n=163 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra®
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)
|
237 Participants
|
105 Participants
|
125 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to end of study, up to Week 63Population: Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra).
Outcome measures
| Measure |
Core Treatment Period: MSB11456
n=302 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
n=139 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456
n=163 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra®
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced One or More Treatment-Emergent Serious Adverse Event (TESAE)
|
51 Participants
|
20 Participants
|
33 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55Population: All participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra) in either the Core Treatment Period or the Extended Treatment Period and had a valid ADA result at the specific time points.
Outcome measures
| Measure |
Core Treatment Period: MSB11456
n=302 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
n=302 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456
n=266 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
n=139 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra®
n=136 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADAs)
Overall (includes all time points expect Baseline)
|
96.0 percentage of participants
|
96.3 percentage of participants
|
97.4 percentage of participants
|
97.1 percentage of participants
|
94.1 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADAs)
Baseline
|
6.6 percentage of participants
|
8.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADAs)
Week 2
|
87.1 percentage of participants
|
88.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADAs)
Week 24 (Extended Treatment Period Baseline)
|
76.3 percentage of participants
|
68.6 percentage of participants
|
86.8 percentage of participants
|
77.7 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADAs)
Week 30
|
—
|
—
|
76.7 percentage of participants
|
73.1 percentage of participants
|
65.9 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADAs)
Week 52
|
—
|
—
|
80.9 percentage of participants
|
76.8 percentage of participants
|
61.1 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADAs)
Week 55
|
—
|
—
|
81.4 percentage of participants
|
82.8 percentage of participants
|
77.9 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADAs)
Week 12
|
79.0 percentage of participants
|
74.3 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55Population: All participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra) in either the Core Treatment Period or the Extended Treatment Period and had a valid ADA result at the specific time points.
Outcome measures
| Measure |
Core Treatment Period: MSB11456
n=302 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
n=302 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456
n=266 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
n=139 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra®
n=136 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
|---|---|---|---|---|---|
|
Anti-Drug Antibodies (ADAs) Titer Levels
Overall (includes all time points except Baseline)
|
106.3 titer
Interval 60.0 to 15360.0
|
104.0 titer
Interval 60.0 to 122880.0
|
215.4 titer
Interval 60.0 to 15360.0
|
166.3 titer
Interval 60.0 to 15360.0
|
101.1 titer
Interval 60.0 to 960.0
|
|
Anti-Drug Antibodies (ADAs) Titer Levels
Baseline
|
71.4 titer
Interval 60.0 to 960.0
|
130.4 titer
Interval 60.0 to 1920.0
|
—
|
—
|
—
|
|
Anti-Drug Antibodies (ADAs) Titer Levels
Week 2
|
81.2 titer
Interval 60.0 to 1920.0
|
88.1 titer
Interval 60.0 to 15360.0
|
—
|
—
|
—
|
|
Anti-Drug Antibodies (ADAs) Titer Levels
Week 12
|
113.8 titer
Interval 60.0 to 960.0
|
123.1 titer
Interval 60.0 to 122880.0
|
—
|
—
|
—
|
|
Anti-Drug Antibodies (ADAs) Titer Levels
Week 24 (Extended Treatment Period Baseline)
|
138.4 titer
Interval 60.0 to 15360.0
|
102.9 titer
Interval 60.0 to 1920.0
|
127.7 titer
Interval 60.0 to 15360.0
|
106.1 titer
Interval 60.0 to 1920.0
|
95.6 titer
Interval 60.0 to 960.0
|
|
Anti-Drug Antibodies (ADAs) Titer Levels
Week 30
|
—
|
—
|
173.0 titer
Interval 60.0 to 15360.0
|
130.6 titer
Interval 60.0 to 7680.0
|
93.7 titer
Interval 60.0 to 960.0
|
|
Anti-Drug Antibodies (ADAs) Titer Levels
Week 52
|
—
|
—
|
230.9 titer
Interval 60.0 to 7680.0
|
174.7 titer
Interval 60.0 to 15360.0
|
96.7 titer
Interval 60.0 to 480.0
|
|
Anti-Drug Antibodies (ADAs) Titer Levels
Week 55
|
—
|
—
|
251.2 titer
Interval 60.0 to 15360.0
|
200.8 titer
Interval 60.0 to 15360.0
|
112.4 titer
Interval 60.0 to 480.0
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55Population: All participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra) in either the Core Treatment Period or the Extended Treatment Period and had a valid ADA result at the specific time points.
Outcome measures
| Measure |
Core Treatment Period: MSB11456
n=302 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: RoActemra®
n=302 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24).
|
Core Treatment Period: MSB11456; Extended Treatment Period: MSB11456
n=266 Participants
Participants received MSB11456 subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
n=139 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
Core Treatment Period: EU-approved RoActemra®; Extended Treatment Period: EU-approved RoActemra®
n=136 Participants
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to continue receiving EU-approved RoActemra® subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Neutralizing Antibodies (NAb)
Overall (includes all time points except Baseline)
|
8.4 percentage of participants
|
11.3 percentage of participants
|
13.2 percentage of participants
|
16.8 percentage of participants
|
11.9 percentage of participants
|
|
Percentage of Participants With Neutralizing Antibodies (NAb)
Baseline
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Neutralizing Antibodies (NAb)
Week 2
|
3.8 percentage of participants
|
3.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Neutralizing Antibodies (NAb)
Week 12
|
2.5 percentage of participants
|
4.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Neutralizing Antibodies (NAb)
Week 24 (Extended Treatment Period Baseline)
|
2.9 percentage of participants
|
4.9 percentage of participants
|
3.8 percentage of participants
|
5.8 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Neutralizing Antibodies (NAb)
Week 30
|
—
|
—
|
6.1 percentage of participants
|
9.7 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants With Neutralizing Antibodies (NAb)
Week 52
|
—
|
—
|
1.6 percentage of participants
|
2.4 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Neutralizing Antibodies (NAb)
Week 55
|
—
|
—
|
7.0 percentage of participants
|
6.6 percentage of participants
|
9.0 percentage of participants
|
Adverse Events
MSB11456
Serious events: 51 serious events
Other events: 163 other events
Deaths: 0 deaths
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
Serious events: 20 serious events
Other events: 82 other events
Deaths: 1 deaths
EU-approved RoActemra®
Serious events: 33 serious events
Other events: 92 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
MSB11456
n=302 participants at risk
All participants who received MSB11456 in the Core Treatment Period (Baseline to Week 24) and who could then be re-randomized to continue MSB11456 in the Extended Treatment Period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
n=139 participants at risk
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
EU-approved RoActemra®
n=163 participants at risk
All participants who received EU-approved RoActemra® in the Core Treatment Period (Baseline to Week 24) and who could then re-randomized to continue RoActemra® in the Extended Treatment Period (Week 24 to Week 52).
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
12.6%
38/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
8.6%
12/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
11.7%
19/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Abscess limb
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.66%
2/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Cellulitis
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.66%
2/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Cardiac disorders
Cardiogenic shock
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Vascular disorders
Thrombophlebitis
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
Other adverse events
| Measure |
MSB11456
n=302 participants at risk
All participants who received MSB11456 in the Core Treatment Period (Baseline to Week 24) and who could then be re-randomized to continue MSB11456 in the Extended Treatment Period (Week 24 to Week 52).
|
Core Treatment Period: RoActemra®; Extended Treatment Period: MSB11456
n=139 participants at risk
Participants received EU-approved RoActemra® subcutaneously, once a week during the core treatment period (Baseline to Week 24). Participants were then re-randomized to begin receiving MSB11456 subcutaneously, once a week during the extended treatment period (Week 24 to Week 52).
|
EU-approved RoActemra®
n=163 participants at risk
All participants who received EU-approved RoActemra® in the Core Treatment Period (Baseline to Week 24) and who could then re-randomized to continue RoActemra® in the Extended Treatment Period (Week 24 to Week 52).
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
11.9%
36/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
15.8%
22/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
13.5%
22/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Investigations
Aspartate aminotransferase increased
|
6.3%
19/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
6.5%
9/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
6.1%
10/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.3%
22/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
5.8%
8/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
7.4%
12/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.3%
19/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
5.8%
8/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
6.1%
10/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.3%
10/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
3.6%
5/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
3.7%
6/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.6%
11/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.4%
2/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
4.3%
7/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Investigations
Blood bilirubin increased
|
3.6%
11/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
5.8%
8/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.8%
3/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Investigations
Mycobacterium tuberculosis complex test positive
|
4.6%
14/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.9%
4/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Investigations
Blood pressure increased
|
2.0%
6/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.9%
4/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
3.7%
6/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Investigations
Blood bilirubin unconjugated increased
|
1.7%
5/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
3.6%
5/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Investigations
Blood cholesterol increased
|
1.3%
4/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.9%
4/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.8%
3/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.7%
5/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.4%
2/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Investigations
Low density lipoprotein increased
|
1.7%
5/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.9%
4/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.2%
2/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.66%
2/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
COVID-19
|
12.6%
38/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
8.6%
12/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
11.7%
19/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
17/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
4.3%
6/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
6.1%
10/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
9/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
3.6%
5/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
5.5%
9/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
5/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.9%
4/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.8%
3/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Bronchitis
|
2.3%
7/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.8%
3/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Infections and infestations
Pharyngitis
|
0.66%
2/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
5/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
4.3%
6/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.2%
2/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.7%
5/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.72%
1/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
9/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
3.7%
6/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
7/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.2%
3/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.3%
10/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
3.6%
5/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
3.1%
5/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
2.3%
7/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.9%
4/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Nervous system disorders
Headache
|
5.6%
17/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.4%
2/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Nervous system disorders
Dizziness
|
1.3%
4/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.4%
2/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
4/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.9%
4/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.99%
3/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
1.4%
2/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.33%
1/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.2%
3/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.00%
0/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Vascular disorders
Hypertension
|
4.3%
13/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
4.3%
6/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.5%
4/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.66%
2/302 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
2.9%
4/139 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
0.61%
1/163 • Day 1 up to Week 63
Safety Analysis Set: all participants who received at least one dose of study drug (MBS11456 or EU-approved RoActemra). The tables below only include treatment-emergent adverse events and "Other Adverse Events" only include non-serious TEAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place