Trial Outcomes & Findings for A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis (NCT NCT01987479)
NCT ID: NCT01987479
Last Updated: 2017-06-19
Results Overview
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events.
COMPLETED
PHASE3
150 participants
Baseline up to Week 32
2017-06-19
Participant Flow
A total of 174 participants were screened, out of which 150 participants met eligibility criteria and were enrolled into the study.
Participant milestones
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
Participants received a weekly subcutaneous (SC) injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) for 24 weeks.
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|---|---|
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Overall Study
STARTED
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150
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Overall Study
COMPLETED
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133
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Overall Study
NOT COMPLETED
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17
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Reasons for withdrawal
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
Participants received a weekly subcutaneous (SC) injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) for 24 weeks.
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|---|---|
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Overall Study
Protocol Violation
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1
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Overall Study
Physician Decision
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2
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Overall Study
Participant/legal guardian decision
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1
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Overall Study
Other
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5
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Overall Study
Lost to Follow-up
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1
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Overall Study
Adverse Event
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7
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Baseline Characteristics
A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
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|---|---|
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Age, Continuous
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55.85 years
STANDARD_DEVIATION 11.20 • n=5 Participants
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Sex: Female, Male
Female
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110 Participants
n=5 Participants
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Sex: Female, Male
Male
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40 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline up to Week 32Population: FAS population
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
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|---|---|
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Percentage of Participants With Adverse Events
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91.3 percentage of participants
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SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)Population: FAS population. Here, "n" = participants who were evaluable at the specified timepoint.
DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour \[mm/hour\]), and patient's global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale \[VAS\] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR less than (\<) 2.6 implied clinical remission.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
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|---|---|
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Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Baseline (n=150)
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4.8 units on a scale
Standard Deviation 1.3
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Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 2 (n=148)
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1.337 units on a scale
Standard Deviation 0.989
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Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 4 (n=144)
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2.037 units on a scale
Standard Deviation 0.991
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Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 8 (n=136)
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2.635 units on a scale
Standard Deviation 1.098
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Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 12 (n=133)
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2.908 units on a scale
Standard Deviation 1.135
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Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 16 (n=128)
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3.014 units on a scale
Standard Deviation 1.240
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Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 20 (n=122)
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3.169 units on a scale
Standard Deviation 1.170
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Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 24 (n=121)
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3.232 units on a scale
Standard Deviation 1.247
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Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at early withdrawal visit (n=27)
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1.653 units on a scale
Standard Deviation 1.562
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SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)Population: FAS population. "n" = participants who were evaluable at specified timepoint.
A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either C-reactive protein \[CRP\] or ESR).
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
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|---|---|
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Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response
Week 2 (n=148)
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20.3 percentage of participants
0.989
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Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response
Week 4 (n=144)
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40.3 percentage of participants
0.991
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Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response
Week 8 (n=136)
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58.1 percentage of participants
1.098
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Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response
Week 12 (n=133)
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69.9 percentage of participants
1.135
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Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response
Week 16 (n=130)
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71.5 percentage of participants
1.240
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Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response
Week 20 (n=123)
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78.9 percentage of participants
1.170
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Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response
Week 24 (n=121)
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82.6 percentage of participants
1.247
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Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response
Early withdrawal visit (n=27)
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37.0 percentage of participants
1.562
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SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)Population: FAS population. "n" = participants who were evaluable at specified timepoint.
A participant had an ACR50 response if there was at least a 50% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR).
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
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|---|---|
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Percentage of Participants Achieving an ACR50 Response
Week 2 (n=148)
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6.1 percentage of participants
0.989
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Percentage of Participants Achieving an ACR50 Response
Week 4 (n=144)
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18.1 percentage of participants
0.991
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Percentage of Participants Achieving an ACR50 Response
Week 8 (n=136)
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33.1 percentage of participants
1.098
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Percentage of Participants Achieving an ACR50 Response
Week 12 (n=133)
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43.6 percentage of participants
1.135
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Percentage of Participants Achieving an ACR50 Response
Week 16 (n=130)
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52.3 percentage of participants
1.240
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Percentage of Participants Achieving an ACR50 Response
Week 20 (n=123)
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54.5 percentage of participants
1.170
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Percentage of Participants Achieving an ACR50 Response
Week 24 (n=121)
|
62.0 percentage of participants
1.247
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Percentage of Participants Achieving an ACR50 Response
Early withdrawal visit (n=27)
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18.5 percentage of participants
1.562
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SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)Population: FAS population. "n" = participants who were evaluable at specified timepoint.
A participant had an ACR70 response if there was at least a 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR).
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
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Percentage of Participants Achieving an ACR70 Response
Week 2 (n=148)
|
1.4 percentage of participants
0.989
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Percentage of Participants Achieving an ACR70 Response
Week 4 (n=144)
|
6.9 percentage of participants
0.991
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Percentage of Participants Achieving an ACR70 Response
Week 8 (n=136)
|
14.0 percentage of participants
1.098
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Percentage of Participants Achieving an ACR70 Response
Week 12 (n=133)
|
21.1 percentage of participants
1.135
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Percentage of Participants Achieving an ACR70 Response
Week 16 (n=130)
|
29.2 percentage of participants
1.240
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Percentage of Participants Achieving an ACR70 Response
Week 20 (n=123)
|
38.2 percentage of participants
1.170
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|
Percentage of Participants Achieving an ACR70 Response
Week 24 (n=121)
|
35.5 percentage of participants
1.247
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Percentage of Participants Achieving an ACR70 Response
Early withdrawal visit (n=27)
|
14.8 percentage of participants
1.562
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SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)Population: FAS population. "n" = participants who were evaluable at specified timepoint.
A participant had an ACR90 response if there was at least a 90% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR).
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
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|---|---|
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Percentage of Participants Achieving an ACR90 Response
Week 8 (n=136)
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2.9 percentage of participants
1.098
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Percentage of Participants Achieving an ACR90 Response
Week 20 (n=123)
|
11.4 percentage of participants
1.170
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Percentage of Participants Achieving an ACR90 Response
Week 24 (n=121)
|
15.7 percentage of participants
1.247
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|
Percentage of Participants Achieving an ACR90 Response
Week 2 (n=148)
|
0.0 percentage of participants
0.989
|
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Percentage of Participants Achieving an ACR90 Response
Week 4 (n=144)
|
1.4 percentage of participants
0.991
|
|
Percentage of Participants Achieving an ACR90 Response
Week 12 (n=133)
|
6.8 percentage of participants
1.135
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Percentage of Participants Achieving an ACR90 Response
Week 16 (n=130)
|
9.2 percentage of participants
1.240
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Percentage of Participants Achieving an ACR90 Response
Early withdrawal visit (n=27)
|
3.7 percentage of participants
1.562
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SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)Population: FAS population. "n" = participants who were evaluable at specified timepoint.
DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. The DAS28-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \>1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1. Participants with change from baseline \>0.6 to ≤1.2 with a DAS28 score \>5.1, or any score with change from baseline ≤0.6, were assessed as non-responders.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
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Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Early withdrawal visit: No response (n=27)
|
25.9 percentage of participants
|
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Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 2: Good response (n=148)
|
34.5 percentage of participants
0.989
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 2: Moderate response (n=148)
|
41.9 percentage of participants
0.991
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 2: No response (n=148)
|
23.6 percentage of participants
1.098
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 4: Good response (n=144)
|
59.7 percentage of participants
1.135
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 4: Moderate response (n=144)
|
34.0 percentage of participants
1.240
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 4: No response (n=144)
|
6.3 percentage of participants
1.170
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 8: Good response (n=136)
|
78.7 percentage of participants
1.247
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 8: Moderate response (n=136)
|
17.6 percentage of participants
1.562
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 8: No response (n=136)
|
3.7 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 12: Good response (n=133)
|
85.0 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 12: Moderate response (n=133)
|
12.0 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 12: No response (n=133)
|
3.0 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 16: Good response (n=128)
|
89.1 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 16: Moderate response (n=128)
|
7.0 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 16: No response (n=128)
|
3.9 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 20: Good response (n=122)
|
91.8 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 20: Moderate response (n=122)
|
5.7 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 20: No response (n=122)
|
2.5 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 24: Good response (n=121)
|
92.6 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 24: Moderate response (n=121)
|
5.0 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Week 24: No response (n=121)
|
2.5 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Early withdrawal visit: Good response (n=27)
|
44.4 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
Early withdrawal visit: Moderate response (n=27)
|
29.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)Population: FAS population. Here, "Overall Number of Participants Analyzed" = participants who were evaluable for this outcome. "n" = participants who were evaluable at specified timepoint.
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease activity assessed on 0-10 centimeter (cm) VAS (0 cm= no disease activity and 10 cm= worst disease activity), and CRP in milligrams per liter (mg/L). SDAI total score = 0-86. SDAI \<=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity .
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=145 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Baseline (n=145)
|
26.03 units on a scale
Standard Deviation 12.55
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 2 (n=97)
|
-6.2 units on a scale
Standard Deviation 7.4
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 4 (n=78)
|
-11.3 units on a scale
Standard Deviation 8.0
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 8 (n=64)
|
-14.4 units on a scale
Standard Deviation 9.2
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 12 (n=63)
|
-17.2 units on a scale
Standard Deviation 10.8
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 16 (n=67)
|
-18.5 units on a scale
Standard Deviation 11.1
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 20 (n=57)
|
-19.7 units on a scale
Standard Deviation 11.2
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at Week 24 (n=56)
|
-19.9 units on a scale
Standard Deviation 11.8
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Change at early withdrawal visit (n=18)
|
-8.0 units on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)Population: FAS population. Here, "n" = participants who were evaluable at specified timepoint.
The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician's global assessment of disease activity assessed on 0-10 cm VAS (0 cm= no disease activity and 10 cm= worst disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal
Change at Week 16 (n=129)
|
-16.7 units on a scale
Standard Deviation 10.1
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal
Change at Week 24 (n=121)
|
-18.3 units on a scale
Standard Deviation 11.1
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal
Baseline (n=150)
|
24.32 units on a scale
Standard Deviation 11.84
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal
Change at Week 2 (n=148)
|
-4.7 units on a scale
Standard Deviation 7.3
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal
Change at Week 4 (n=144)
|
-9.4 units on a scale
Standard Deviation 7.2
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal
Change at Week 8 (n=135)
|
-13.4 units on a scale
Standard Deviation 8.7
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal
Change at Week 12 (n=132)
|
-15.4 units on a scale
Standard Deviation 9.2
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal
Change at Week 20 (n=122)
|
-17.8 units on a scale
Standard Deviation 10.2
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal
Change at early withdrawal visit (n=27)
|
-6.4 units on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)Population: FAS population. Here, "n" = participants who were evaluable at specified timepoint.
Number of tender joints was determined by examining 28 joints for TJC28 and 68 joints for TJC68, and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 for a TJC28 and 68 for a TJC68. A reduction in number of tender joints compared to baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC28: Change at Week 4 (n=144)
|
-2.94 tender joints
Standard Deviation 3.89
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC28: Baseline (n=150)
|
7.7 tender joints
Standard Deviation 6.5
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC28: Change at Week 2 (n=148)
|
-1.38 tender joints
Standard Deviation 3.71
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC28: Change at Week 8 (n=136)
|
-4.33 tender joints
Standard Deviation 4.82
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC28: Change at Week 12 (n=133)
|
-4.68 tender joints
Standard Deviation 5.05
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC28: Change at Week 16 (n=130)
|
-5.36 tender joints
Standard Deviation 5.55
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC28: Change at Week 20 (n=123)
|
-5.79 tender joints
Standard Deviation 5.24
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC28: Change at Week 24 (n=121)
|
-5.96 tender joints
Standard Deviation 5.67
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC28: Change at early withdrawal visit (n=27)
|
-1.07 tender joints
Standard Deviation 4.59
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC68: Baseline (n=150)
|
13.2 tender joints
Standard Deviation 10.0
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC68: Change at Week 2 (n=148)
|
-2.40 tender joints
Standard Deviation 5.84
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC68: Change at Week 4 (n=144)
|
-5.15 tender joints
Standard Deviation 6.25
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC68: Change at Week 8 (n=136)
|
-7.19 tender joints
Standard Deviation 7.57
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC68: Change at Week 12 (n=133)
|
-7.98 tender joints
Standard Deviation 8.46
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC68: Change at Week 16 (n=130)
|
-9.45 tender joints
Standard Deviation 9.07
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC68: Change at Week 20 (n=123)
|
-9.86 tender joints
Standard Deviation 9.04
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC68: Change at Week 24 (n=121)
|
-10.02 tender joints
Standard Deviation 8.94
|
|
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
TJC68: Change at early withdrawal visit (n=27)
|
-1.93 tender joints
Standard Deviation 8.53
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)Population: FAS population. Here, "n" = participants who were evaluable at specified timepoint.
Number of swollen joints was determined by examination of 28 joints for SJC28 and 66 joints for SJC66 and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 for a SJC28 and 66 for a SJC66. A reduction in number of swollen joints compared to baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC28: Baseline (n=150)
|
6.2 swollen joints
Standard Deviation 5.4
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC28: Change at Week 2 (n=148)
|
-1.18 swollen joints
Standard Deviation 3.04
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC28: Change at Week 4 (n=144)
|
-2.44 swollen joints
Standard Deviation 3.33
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC28: Change at Week 8 (n=136)
|
-3.62 swollen joints
Standard Deviation 3.86
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC28: Change at Week 12 (n=133)
|
-4.24 swollen joints
Standard Deviation 4.17
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC28: Change at Week 16 (n=130)
|
-4.61 swollen joints
Standard Deviation 4.14
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC28: Change at Week 20 (n=123)
|
-4.92 swollen joints
Standard Deviation 4.24
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC28: Change at Week 24 (n=121)
|
-5.23 swollen joints
Standard Deviation 4.63
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC28: Change at early withdrawal visit (n=27)
|
-1.33 swollen joints
Standard Deviation 4.18
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC66: Baseline (n=150)
|
9.1 swollen joints
Standard Deviation 7.3
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC66: Change at Week 2 (n=148)
|
-1.84 swollen joints
Standard Deviation 4.16
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC66: Change at Week 4 (n=144)
|
-3.94 swollen joints
Standard Deviation 4.35
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC66: Change at Week 8 (n=136)
|
-5.61 swollen joints
Standard Deviation 4.74
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC66: Change at Week 12 (n=133)
|
-6.50 swollen joints
Standard Deviation 5.79
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC66: Change at Week 16 (n=130)
|
-6.78 swollen joints
Standard Deviation 5.95
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC66: Change at Week 20 (n=123)
|
-7.52 swollen joints
Standard Deviation 6.44
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC66: Change at Week 24 (n=121)
|
-7.80 swollen joints
Standard Deviation 6.86
|
|
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
SJC66: Change at early withdrawal visit (n=27)
|
-2.33 swollen joints
Standard Deviation 4.89
|
SECONDARY outcome
Timeframe: From Week 16 and before Week 20; From Week 20 and before Week 24Population: FAS population
Results are reported for percentage of participants who had NSAIDs dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort).
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons
Unknown reasons (Week 16 to Week 20)
|
0.0 percentage of participants
|
|
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons
Safety reasons (Week 16 to Week 20)
|
0.7 percentage of participants
|
|
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons
Other reasons (Week 16 to Week 20)
|
0.7 percentage of participants
|
|
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons
Lack of efficacy (Week 16 to Week 20)
|
0.0 percentage of participants
|
|
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons
Discomfort (Week 16 to Week 20)
|
0.0 percentage of participants
|
|
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons
Unknown reasons (Week 20 to Week 24)
|
0.0 percentage of participants
|
|
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons
Safety reasons (Week 20 to Week 24)
|
0.0 percentage of participants
|
|
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons
Other reasons (Week 20 to Week 24)
|
0.0 percentage of participants
|
|
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons
Lack of efficacy (Week 20 to Week 24)
|
0.0 percentage of participants
|
|
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons
Discomfort (Week 20 to Week 24)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Week 16 and before Week 20; From Week 20 and before Week 24Population: FAS population
Results are reported for percentage of participants who had corticosteroid dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort).
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons
Unknown reasons (Week 16 to Week 20)
|
0.0 percentage of participants
|
|
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons
Safety reasons (Week 16 to Week 20)
|
1.3 percentage of participants
|
|
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons
Other reasons (Week 16 to Week 20)
|
0.7 percentage of participants
|
|
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons
Lack of efficacy (Week 16 to Week 20)
|
0.0 percentage of participants
|
|
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons
Discomfort (Week 16 to Week 20)
|
0.0 percentage of participants
|
|
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons
Unknown reasons (Week 20 to Week 24)
|
0.0 percentage of participants
|
|
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons
Safety reasons (Week 20 to Week 24)
|
0.0 percentage of participants
|
|
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons
Other reasons (Week 20 to Week 24)
|
1.3 percentage of participants
|
|
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons
Lack of efficacy (Week 20 to Week 24)
|
0.7 percentage of participants
|
|
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons
Discomfort (Week 20 to Week 24)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 32Population: FAS population
Time to discontinuation or first dose reduction of corticosteroids or NSAIDs (weeks) = (Date of the first dose reduction or end date of corticosteroids or NSAIDs treatment - date of first drug intake of this study) + 1. Time to discontinuation or first dose reduction was based on the first occurring event (corticosteroid discontinuation or corticosteroid first dose reduction or NSAIDs discontinuation or NSAIDs first dose reduction, whichever occurred first).
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Time to Discontinuation or First Dose Reduction of Corticosteroids or NSAIDs
|
25.3 weeks
Interval 25.0 to 28.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24, early withdrawal (up to Week 24), follow-up visit (8 weeks after last dose of tocilizumab, up to 32 weeks)Population: FAS population. Here, "n" = participants who were evaluable at specified timepoint.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Percentage of Participants With Anti-Tocilizumab Antibodies
Baseline (n=147)
|
6.1 percentage of participants
0.5906
|
|
Percentage of Participants With Anti-Tocilizumab Antibodies
Week 12 (n=5)
|
40.0 percentage of participants
0.5734
|
|
Percentage of Participants With Anti-Tocilizumab Antibodies
Week 24 (n=121)
|
7.4 percentage of participants
0.5587
|
|
Percentage of Participants With Anti-Tocilizumab Antibodies
Early withdrawal (n=22)
|
9.1 percentage of participants
0.5330
|
|
Percentage of Participants With Anti-Tocilizumab Antibodies
Follow-up visit (n=26)
|
11.5 percentage of participants
0.5682
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks)Population: FAS population. "n" = participants who were evaluable at specified timepoint.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Serum Levels of Tocilizumab
Baseline (n=4)
|
0.5 micrograms per milliliter (mcg/mL)
Standard Deviation 0.3
|
|
Serum Levels of Tocilizumab
Week 12 (n=123)
|
42.3 micrograms per milliliter (mcg/mL)
Standard Deviation 25.2
|
|
Serum Levels of Tocilizumab
Week 24 (n=112)
|
46.5 micrograms per milliliter (mcg/mL)
Standard Deviation 29.2
|
|
Serum Levels of Tocilizumab
Early withdrawal (n=17)
|
16.8 micrograms per milliliter (mcg/mL)
Standard Deviation 19.3
|
|
Serum Levels of Tocilizumab
Follow-up visit (n=3)
|
60.9 micrograms per milliliter (mcg/mL)
Standard Deviation 29.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks)Population: FAS population. "n" = participants who were evaluable at specified timepoint.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)
Baseline (n=139)
|
38.3 nanograms per milliliter (ng/mL)
Standard Deviation 10.4
|
|
Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)
Week 12 (n=126)
|
516.6 nanograms per milliliter (ng/mL)
Standard Deviation 137.7
|
|
Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)
Week 24 (n=115)
|
536.5 nanograms per milliliter (ng/mL)
Standard Deviation 161.6
|
|
Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)
Early withdrawal (n=21)
|
380.4 nanograms per milliliter (ng/mL)
Standard Deviation 215.2
|
|
Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)
Follow-up visit (n=26)
|
117.5 nanograms per milliliter (ng/mL)
Standard Deviation 194.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24)Population: FAS population. Here, "n" = participants who were evaluable at specified timepoint.
Patient global assessment of disease activity was measured on a 0 to 100 mm horizontal VAS where 0 mm=no disease activity and 100 mm=maximum disease activity.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Patient Global Assessment of Disease Activity VAS Scores
Baseline (n=150)
|
54.8 mm
Standard Deviation 22.3
|
|
Patient Global Assessment of Disease Activity VAS Scores
Week 2 (n=148)
|
43.6 mm
Standard Deviation 23.0
|
|
Patient Global Assessment of Disease Activity VAS Scores
Week 4 (n=144)
|
35.5 mm
Standard Deviation 23.0
|
|
Patient Global Assessment of Disease Activity VAS Scores
Week 8 (n=136)
|
27.2 mm
Standard Deviation 21.8
|
|
Patient Global Assessment of Disease Activity VAS Scores
Week 12 (n=133)
|
22.2 mm
Standard Deviation 20.3
|
|
Patient Global Assessment of Disease Activity VAS Scores
Week 16 (n=129)
|
21.3 mm
Standard Deviation 21.0
|
|
Patient Global Assessment of Disease Activity VAS Scores
Week 20 (n=123)
|
19.2 mm
Standard Deviation 18.6
|
|
Patient Global Assessment of Disease Activity VAS Scores
Week 24 (n=121)
|
18.8 mm
Standard Deviation 19.5
|
|
Patient Global Assessment of Disease Activity VAS Scores
Early withdrawal (n=27)
|
40.4 mm
Standard Deviation 30.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24)Population: FAS population. Here, "n" = participants who were evaluable at specified timepoint.
This assessment represents the participant's assessment of his/her current level of pain on a 100 mm horizontal VAS where 0 mm= no pain to 100 mm= unbearable pain.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Patient Pain VAS Scores
Week 20 (n=123)
|
19.5 mm
Standard Deviation 18.0
|
|
Patient Pain VAS Scores
Week 24 (n=121)
|
19.6 mm
Standard Deviation 18.8
|
|
Patient Pain VAS Scores
Baseline (n=150)
|
52.5 mm
Standard Deviation 22.1
|
|
Patient Pain VAS Scores
Week 2 (n=148)
|
44.4 mm
Standard Deviation 21.9
|
|
Patient Pain VAS Scores
Week 4 (n=144)
|
35.8 mm
Standard Deviation 22.3
|
|
Patient Pain VAS Scores
Week 8 (n=136)
|
27.6 mm
Standard Deviation 21.3
|
|
Patient Pain VAS Scores
Week 12 (n=133)
|
21.7 mm
Standard Deviation 19.0
|
|
Patient Pain VAS Scores
Week 16 (n=129)
|
20.9 mm
Standard Deviation 20.2
|
|
Patient Pain VAS Scores
Early withdrawal (n=27)
|
42.8 mm
Standard Deviation 30.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)Population: FAS population. Here, "n" = participants who were evaluable at specified timepoint.
The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Baseline (n=147)
|
1.2329 units on a scale
Standard Deviation 0.5708
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 2 (n=147)
|
1.0978 units on a scale
Standard Deviation 0.5906
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 4 (n=143)
|
0.9673 units on a scale
Standard Deviation 0.5734
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 8 (n=134)
|
0.8249 units on a scale
Standard Deviation 0.5587
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 12 (n=131)
|
0.7460 units on a scale
Standard Deviation 0.5330
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 16 (n=129)
|
0.6996 units on a scale
Standard Deviation 0.5682
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 20 (n=122)
|
0.6620 units on a scale
Standard Deviation 0.5333
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 24 (n=119)
|
0.6681 units on a scale
Standard Deviation 0.5745
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Early withdrawal (n=27)
|
1.2315 units on a scale
Standard Deviation 0.6853
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)Population: FAS population. "n" = participants who were evaluable at specified timepoint.
A diary card was provided to participants to record home injections. Participants were asked to return all empty drug supply boxes, unused pre-filled syringe, and diary cards to the clinic at each visit as a measure of drug accountability and participant compliance. A participant was considered compliant if the participant correctly administered all scheduled doses of SC tocilizumab during the assessment period.
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records
Week 2 (n=148)
|
90.5 percentage of participants
0.5906
|
|
Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records
Week 4 (n=144)
|
95.8 percentage of participants
0.5734
|
|
Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records
Week 8 (n=136)
|
91.9 percentage of participants
0.5587
|
|
Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records
Week 12 (n=133)
|
97.7 percentage of participants
0.5330
|
|
Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records
Week 16 (n=130)
|
93.8 percentage of participants
0.5682
|
|
Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records
Week 20 (n=123)
|
95.1 percentage of participants
0.5333
|
|
Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records
Week 24 (n=121)
|
92.6 percentage of participants
0.5745
|
|
Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records
Early withdrawal (n=27)
|
88.9 percentage of participants
0.6853
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)Population: FAS population. Here, "n" = participants who were evaluable at specified timepoint.
The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Outcome measures
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 Participants
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Week 16 (n=122)
|
37.93 units on a scale
Standard Deviation 9.11
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Week 20 (n=118)
|
39.65 units on a scale
Standard Deviation 8.87
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Week 24 (n=114)
|
39.93 units on a scale
Standard Deviation 8.65
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Early withdrawal (n=27)
|
33.48 units on a scale
Standard Deviation 12.06
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Baseline (n=133)
|
29.84 units on a scale
Standard Deviation 9.43
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Week 2 (n=134)
|
33.07 units on a scale
Standard Deviation 9.34
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Week 4 (n=133)
|
35.10 units on a scale
Standard Deviation 10.37
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Week 8 (n=126)
|
37.34 units on a scale
Standard Deviation 9.25
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Week 12 (n=126)
|
37.89 units on a scale
Standard Deviation 8.52
|
Adverse Events
Tocilizumab Alone or in Combination With Methotrexate or DMARD
Serious adverse events
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 participants at risk
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Infections and infestations
Appendicitis
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Infections and infestations
Arthritis bacterial
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Infections and infestations
Skin infection
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Surgical and medical procedures
Prophylaxis
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
|
Vascular disorders
Aortic aneurysm
|
0.67%
1/150 • Baseline up to Week 32
FAS population
|
Other adverse events
| Measure |
Tocilizumab Alone or in Combination With Methotrexate or DMARD
n=150 participants at risk
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
23.3%
35/150 • Baseline up to Week 32
FAS population
|
|
Gastrointestinal disorders
Nausea
|
12.0%
18/150 • Baseline up to Week 32
FAS population
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
9/150 • Baseline up to Week 32
FAS population
|
|
General disorders
Fatigue
|
12.0%
18/150 • Baseline up to Week 32
FAS population
|
|
Nervous system disorders
Dizziness
|
7.3%
11/150 • Baseline up to Week 32
FAS population
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
8/150 • Baseline up to Week 32
FAS population
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
8/150 • Baseline up to Week 32
FAS population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
8/150 • Baseline up to Week 32
FAS population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER