Trial Outcomes & Findings for An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy. (NCT NCT00750880)
NCT ID: NCT00750880
Last Updated: 2015-07-22
Results Overview
Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1681 participants
Primary outcome timeframe
Weeks 4, 8, 12, 16, 20, and 24
Results posted on
2015-07-22
Participant Flow
Participant milestones
| Measure |
Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)
Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 20 weeks (total of 6 infusions).
|
|---|---|
|
Overall Study
STARTED
|
1681
|
|
Overall Study
COMPLETED
|
1466
|
|
Overall Study
NOT COMPLETED
|
215
|
Reasons for withdrawal
| Measure |
Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)
Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 20 weeks (total of 6 infusions).
|
|---|---|
|
Overall Study
Adverse Event
|
76
|
|
Overall Study
Death
|
4
|
|
Overall Study
Lack of Efficacy
|
46
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Protocol Violation
|
15
|
|
Overall Study
Withdrawal by Subject
|
33
|
|
Overall Study
Physician Decision
|
20
|
|
Overall Study
Administrative
|
11
|
Baseline Characteristics
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
Baseline characteristics by cohort
| Measure |
Tocilizumab 8 mg/kg
n=1681 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
|
|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1356 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
325 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: Safety population: all participants included in the study who received at least 1 dose of study medication and who had at least 1 postbaseline assessment of safety (post-baseline laboratory data, vital signs, or adverse events). number (n) equals (=) number of participants analyzed for the parameter within the specific population.
Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.
Outcome measures
| Measure |
Tocilizumab
n=1681 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
Any AE
|
77.4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
Related AE
|
58.4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
Severe AE
|
7.8 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
SAE
|
7.8 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
Related SAE
|
3.5 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
AE leading to withdrawal
|
5.1 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
AE leading to dose modification
|
10.8 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
Infection
|
35.3 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
Serious infection
|
2.1 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
Any infusion reaction (during or within 24 hours)
|
17.3 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
Infusion reaction during infusion
|
6.7 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
Infusion reaction within 24 hours of infusion
|
12.6 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
MACE
|
0.4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs): Overall Summary
Death
|
0.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; no imputation of missing data was performed for this analysis.
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 less than or equal to (≤)3.2 and remission was defined as DAS28 less than (\<)2.6.
Outcome measures
| Measure |
Tocilizumab
n=1677 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Baseline, low disease activity (n=1677)
|
1.1 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Baseline, DAS28 <2.6 (n=1677)
|
0.2 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 4, low disease activity (n=1635)
|
27.6 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 4, DAS28 <2.6 (n=1635)
|
14.9 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 8, low disease activity (n=1594)
|
49.2 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 8, DAS28 <2.6 (n=1594)
|
32.6 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 12, low disease activity (n=1556)
|
57.3 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 12, DAS28 <2.6 (n=1556)
|
40.0 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 16, low disease activity (n=1509)
|
64.7 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 16, DAS28 <2.6 (n=1509)
|
48.4 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 20, low disease activity (n=1467)
|
69.3 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 20, DAS28 <2.6 (n=1467)
|
54.9 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 24, low disease activity (n=1455)
|
69.9 percentage of participants
|
|
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Week 24, DAS28 <2.6 (n=1455)
|
56.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; Only population with complete DAS28 data were analyzed.
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 ≤3.2 and remission was defined as DAS28 \<2.6.
Outcome measures
| Measure |
Tocilizumab
n=1665 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event
Low disease activity
|
1320 participants
|
|
Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event
DAS28 <2.6
|
1127 participants
|
SECONDARY outcome
Timeframe: Baseline,Weeks 4, 8, 12, 16, 20, and 24Population: ITT population with DAS28 ≤3.2
The time to low disease activity or remission was calculated as the number of days from study Day 1 to the first occurrence of low disease activity or remission. Participants who did not achieve low disease activity on or before Week 24 or who withdrew from the study prior to achieving low disease activity were considered censored. DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity defined as DAS28 ≤3.2 and remission defined as DAS28 \<2.6.
Outcome measures
| Measure |
Tocilizumab
n=1320 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event
Low disease activity (n=1320)
|
63.0 days
Interval 60.0 to 80.0
|
|
Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event
Remission (n=1127)
|
112.0 days
Interval 97.0 to 113.0
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: ITT population
DAS28-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: change from baseline \>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to ≤5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline \>0.6 and ≤1.2 with DAS28 \>5.1. If the EULAR response could not be determined, it was set to 'No response'.
Outcome measures
| Measure |
Tocilizumab
n=1681 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 4, Good Response
|
24.7 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 4, Moderate Response
|
52.6 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 4, No Response
|
22.7 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 8, Good Response
|
44.7 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 8, Moderate Response
|
40.8 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 8, No Response
|
14.5 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 12, Good Response
|
51.3 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 12, Moderate Response
|
34.9 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 12, No Response
|
13.7 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 16, Good Response
|
57.0 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 16, Moderate Response
|
27.5 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 16, No Response
|
15.5 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 20, Good Response
|
59.3 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 20, Moderate Response
|
23.7 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 20, No Response
|
17.0 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 24, Good Response
|
59.6 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 24, Moderate Response
|
23.8 percentage of participants
|
|
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Week 24, No Response
|
16.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=1677 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
DAS28 Scores by Visit
Baseline (n=1677)
|
5.96 units on a scale
Standard Deviation 1.201
|
|
DAS28 Scores by Visit
Week 4 (n=1635)
|
4.12 units on a scale
Standard Deviation 1.451
|
|
DAS28 Scores by Visit
Change at Week 4 (n=1631)
|
-1.84 units on a scale
Standard Deviation 1.165
|
|
DAS28 Scores by Visit
Week 8 (n=1594)
|
3.35 units on a scale
Standard Deviation 1.442
|
|
DAS28 Scores by Visit
Change at Week 8 (n=1590)
|
-2.60 units on a scale
Standard Deviation 1.336
|
|
DAS28 Scores by Visit
Week 12 (n=1556)
|
3.03 units on a scale
Standard Deviation 1.431
|
|
DAS28 Scores by Visit
Change at Week 12 (n=1552)
|
-2.92 units on a scale
Standard Deviation 1.429
|
|
DAS28 Scores by Visit
Week 16 (n=1509)
|
2.80 units on a scale
Standard Deviation 1.459
|
|
DAS28 Scores by Visit
Change at Week 16 (n=1506)
|
-3.14 units on a scale
Standard Deviation 1.464
|
|
DAS28 Scores by Visit
Week 20 (n=1467)
|
2.63 units on a scale
Standard Deviation 1.428
|
|
DAS28 Scores by Visit
Change at Week 20 (n=1463)
|
-3.14 units on a scale
Standard Deviation 1.488
|
|
DAS28 Scores by Visit
Week 24 (n=1455)
|
2.52 units on a scale
Standard Deviation 1.378
|
|
DAS28 Scores by Visit
Change at Week 24 (n=1451)
|
-3.42 units on a scale
Standard Deviation 1.438
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: ITT population
ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (visual analog scale \[VAS\]); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein \[CRP\]). Participants who did not have the required data to assess ACR status at a given visit were classified as non-responders.
Outcome measures
| Measure |
Tocilizumab
n=1681 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 4, ACR20
|
36.5 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 4, ACR50
|
10.5 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 4, ACR70
|
2.7 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 4, ACR90
|
0.3 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 8, ACR20
|
55.6 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 8, ACR50
|
26.9 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 8, ACR70
|
10.7 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 8, ACR90
|
2.2 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 12, ACR20
|
61.0 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 12, ACR50
|
36.3 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 12, ACR70
|
17.5 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 12, ACR90
|
4.8 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 16, ACR20
|
64.1 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 16, ACR50
|
40.2 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 16, ACR70
|
21.1 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 16, ACR90
|
5.8 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 20, ACR20
|
65.0 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 20, ACR50
|
44.4 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 20, ACR70
|
22.4 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 20, ACR90
|
6.7 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 24, ACR20
|
66.9 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 24, ACR50
|
46.6 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 24, ACR70
|
26.4 percentage of participants
|
|
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Week 24, ACR90
|
8.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: ITT population
ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP).
Outcome measures
| Measure |
Tocilizumab
n=1681 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event
ACR20
|
1431 participants
|
|
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event
ACR50
|
1075 participants
|
|
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event
ACR70
|
659 participants
|
|
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event
ACR90
|
232 participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; only participants with a response (ACR20/ACR50/ACR70/ACR90) were included in the analysis. n=number of participants with a response for the specified parameter
ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP). Time to ACR response was calculated as the number of days from day 1 of study to the date of first achievement of ACR response. Data represent median time for responders only.
Outcome measures
| Measure |
Tocilizumab
n=1431 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response
ACR20 (n=1431)
|
57.0 days
Interval 22.0 to 197.0
|
|
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response
ACR50 (n=1075)
|
84.0 days
Interval 23.0 to 243.0
|
|
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response
ACR70 (n=659)
|
90.0 days
Interval 25.0 to 238.0
|
|
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response
ACR90 (n=232)
|
113.0 days
Interval 27.0 to 197.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; missing data were handled using the LOCF approach.
Number of swollen joints was determined by examination of 66 joints 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 66. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=1681 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Swollen Joint Count by Visit
Week 12
|
5.62 swollen joints
Standard Deviation 8.324
|
|
Swollen Joint Count by Visit
Baseline
|
12.76 swollen joints
Standard Deviation 9.183
|
|
Swollen Joint Count by Visit
Week 4
|
9.24 swollen joints
Standard Deviation 10.371
|
|
Swollen Joint Count by Visit
Change at Week 4
|
-3.52 swollen joints
Standard Deviation 10.882
|
|
Swollen Joint Count by Visit
Week 8
|
6.56 swollen joints
Standard Deviation 8.799
|
|
Swollen Joint Count by Visit
Change at Week 8
|
-6.20 swollen joints
Standard Deviation 10.597
|
|
Swollen Joint Count by Visit
Change at Week 12
|
-7.14 swollen joints
Standard Deviation 10.737
|
|
Swollen Joint Count by Visit
Week 16
|
5.24 swollen joints
Standard Deviation 8.441
|
|
Swollen Joint Count by Visit
Change at Week 16
|
-7.52 swollen joints
Standard Deviation 11.114
|
|
Swollen Joint Count by Visit
Week 20
|
4.77 swollen joints
Standard Deviation 8.150
|
|
Swollen Joint Count by Visit
Change at Week 20
|
-7.99 swollen joints
Standard Deviation 11.130
|
|
Swollen Joint Count by Visit
Week 24
|
4.60 swollen joints
Standard Deviation 8.216
|
|
Swollen Joint Count by Visit
Change at Week 24
|
-8.16 swollen joints
Standard Deviation 11.179
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; missing data were handled using the last observation carried forward (LOCF) approach.
Number of tender joints was determined by examining 68 joints 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 68. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=1681 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Tender Joint Count by Visit
Baseline
|
22.82 tender joints
Standard Deviation 15.019
|
|
Tender Joint Count by Visit
Week 4
|
16.55 tender joints
Standard Deviation 15.024
|
|
Tender Joint Count by Visit
Change at Week 4
|
-6.27 tender joints
Standard Deviation 13.384
|
|
Tender Joint Count by Visit
Week 8
|
12.21 tender joints
Standard Deviation 13.227
|
|
Tender Joint Count by Visit
Change at Week 8
|
-10.61 tender joints
Standard Deviation 13.960
|
|
Tender Joint Count by Visit
Week 12
|
10.47 tender joints
Standard Deviation 12.831
|
|
Tender Joint Count by Visit
Change at Week 12
|
-12.35 tender joints
Standard Deviation 14.611
|
|
Tender Joint Count by Visit
Week 16
|
9.75 tender joints
Standard Deviation 12.372
|
|
Tender Joint Count by Visit
Change at Week 16
|
-13.06 tender joints
Standard Deviation 14.876
|
|
Tender Joint Count by Visit
Week 20
|
9.31 tender joints
Standard Deviation 12.326
|
|
Tender Joint Count by Visit
Change at Week 20
|
-13.51 tender joints
Standard Deviation 15.312
|
|
Tender Joint Count by Visit
Week 24
|
8.74 tender joints
Standard Deviation 12.115
|
|
Tender Joint Count by Visit
Change at Week 24
|
-14.08 tender joints
Standard Deviation 15.520
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line=0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm, as "maximum disease activity" (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Tocilizumab
n=1677 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Patient's Global Assessment of Disease Activity by Visit
Baseline (n=1677)
|
62.52 mm
Standard Deviation 21.192
|
|
Patient's Global Assessment of Disease Activity by Visit
Week 4 (n=1653)
|
47.20 mm
Standard Deviation 23.945
|
|
Patient's Global Assessment of Disease Activity by Visit
Change at Week 4 (n=1649)
|
-15.32 mm
Standard Deviation 23.852
|
|
Patient's Global Assessment of Disease Activity by Visit
Week 8 (n=1610)
|
37.95 mm
Standard Deviation 24.377
|
|
Patient's Global Assessment of Disease Activity by Visit
Change at Week 8 (n=1606)
|
-24.52 mm
Standard Deviation 25.972
|
|
Patient's Global Assessment of Disease Activity by Visit
Week 12 (n=1569)
|
33.27 mm
Standard Deviation 23.474
|
|
Patient's Global Assessment of Disease Activity by Visit
Change at Week 12 (n=1565)
|
-28.98 mm
Standard Deviation 25.885
|
|
Patient's Global Assessment of Disease Activity by Visit
Week 16 (n=1525)
|
30.92 mm
Standard Deviation 23.720
|
|
Patient's Global Assessment of Disease Activity by Visit
Change at Week 16 (n=1522)
|
-31.42 mm
Standard Deviation 26.213
|
|
Patient's Global Assessment of Disease Activity by Visit
Week 20 (n=1488)
|
28.74 mm
Standard Deviation 22.948
|
|
Patient's Global Assessment of Disease Activity by Visit
Change at Week 20 (n=1484)
|
-33.42 mm
Standard Deviation 26.160
|
|
Patient's Global Assessment of Disease Activity by Visit
Week 24 (n=1472)
|
26.68 mm
Standard Deviation 22.070
|
|
Patient's Global Assessment of Disease Activity by Visit
Change at Week 24 (n=1468)
|
-35.53 mm
Standard Deviation 25.558
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line=0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm as "maximum disease activity" (maximum arthritis disease activity). The physician marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Tocilizumab
n=1675 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Physician's Global Assessment of Disease Activity by Visit
Baseline (n=1675)
|
58.82 mm
Standard Deviation 17.886
|
|
Physician's Global Assessment of Disease Activity by Visit
Week 4 (n=1645)
|
39.79 mm
Standard Deviation 19.858
|
|
Physician's Global Assessment of Disease Activity by Visit
Change at Week 4 (n=1640)
|
-18.93 mm
Standard Deviation 20.126
|
|
Physician's Global Assessment of Disease Activity by Visit
Week 8 (n=1605)
|
30.01 mm
Standard Deviation 18.671
|
|
Physician's Global Assessment of Disease Activity by Visit
Change at Week 8 (n=1601)
|
-28.65 mm
Standard Deviation 21.190
|
|
Physician's Global Assessment of Disease Activity by Visit
Week 12 (n=1567)
|
25.71 mm
Standard Deviation 18.217
|
|
Physician's Global Assessment of Disease Activity by Visit
Change at Week 12 (n=1563)
|
-32.72 mm
Standard Deviation 21.295
|
|
Physician's Global Assessment of Disease Activity by Visit
Week 16 (n=1525)
|
23.17 mm
Standard Deviation 17.646
|
|
Physician's Global Assessment of Disease Activity by Visit
Change at Week 16 (n=1521)
|
-35.49 mm
Standard Deviation 21.636
|
|
Physician's Global Assessment of Disease Activity by Visit
Week 20 (n=1482)
|
21.18 mm
Standard Deviation 17.064
|
|
Physician's Global Assessment of Disease Activity by Visit
Change at Week 20 (n=1478)
|
-37.33 mm
Standard Deviation 21.855
|
|
Physician's Global Assessment of Disease Activity by Visit
Week 24 (n=1459)
|
19.53 mm
Standard Deviation 17.183
|
|
Physician's Global Assessment of Disease Activity by Visit
Change at Week 24 (n=1455)
|
-39.10 mm
Standard Deviation 21.984
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The participants assessed their pain using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line=0 mm, and is described as "no pain" and the right-hand extreme=100 mm as "unbearable pain". The participant marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Tocilizumab
n=1675 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Patient's Global Assessment of Pain by Visit
Baseline (n=1675)
|
57.51 mm
Standard Deviation 22.582
|
|
Patient's Global Assessment of Pain by Visit
Week 4 (n=1654)
|
43.10 mm
Standard Deviation 23.563
|
|
Patient's Global Assessment of Pain by Visit
Change at Week 4 (n=1648)
|
-14.41 mm
Standard Deviation 23.441
|
|
Patient's Global Assessment of Pain by Visit
Week 8 (n=1612)
|
34.93 mm
Standard Deviation 23.711
|
|
Patient's Global Assessment of Pain by Visit
Change at Week 8 (n=1606)
|
-22.51 mm
Standard Deviation 25.138
|
|
Patient's Global Assessment of Pain by Visit
Week 12 (n=1572)
|
31.02 mm
Standard Deviation 23.342
|
|
Patient's Global Assessment of Pain by Visit
Change at Week 12 (n=1566)
|
-26.21 mm
Standard Deviation 26.036
|
|
Patient's Global Assessment of Pain by Visit
Week 16 (n=1525)
|
28.56 mm
Standard Deviation 23.016
|
|
Patient's Global Assessment of Pain by Visit
Change at Week 16 (n=1521)
|
-28.59 mm
Standard Deviation 26.079
|
|
Patient's Global Assessment of Pain by Visit
Week 20 (n=1489)
|
26.76 mm
Standard Deviation 22.456
|
|
Patient's Global Assessment of Pain by Visit
Change at Week 20 (n=1483)
|
-30.29 mm
Standard Deviation 26.417
|
|
Patient's Global Assessment of Pain by Visit
Week 24 (n=1473)
|
24.90 mm
Standard Deviation 21.398
|
|
Patient's Global Assessment of Pain by Visit
Change at Week 24 (n=1468)
|
-32.13 mm
Standard Deviation 25.925
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The test for CRP (mg per deciliter \[mg/dL\]) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Outcome measures
| Measure |
Tocilizumab
n=1681 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
C-Reactive Protein by Visit
Baseline (n=1681)
|
1.94 mg/dL
Standard Deviation 2.775
|
|
C-Reactive Protein by Visit
Week 4 (n=1649)
|
0.52 mg/dL
Standard Deviation 1.834
|
|
C-Reactive Protein by Visit
Change at Week 4 (n=1649)
|
-1.40 mg/dL
Standard Deviation 2.243
|
|
C-Reactive Protein by Visit
Week 8 (n=1613)
|
0.36 mg/dL
Standard Deviation 1.372
|
|
C-Reactive Protein by Visit
Change at Week 8 (n=1613)
|
-1.59 mg/dL
Standard Deviation 2.474
|
|
C-Reactive Protein by Visit
Week 12 (n=1571)
|
0.28 mg/dL
Standard Deviation 1.247
|
|
C-Reactive Protein by Visit
Change at Week 12 (n=1571)
|
-1.63 mg/dL
Standard Deviation 2.532
|
|
C-Reactive Protein by Visit
Week 16 (n=1525)
|
0.23 mg/dL
Standard Deviation 0.798
|
|
C-Reactive Protein by Visit
Change at Week 16 (n=1525)
|
-1.70 mg/dL
Standard Deviation 2.655
|
|
C-Reactive Protein by Visit
Week 20 (n=1481)
|
0.23 mg/dL
Standard Deviation 1.078
|
|
C-Reactive Protein by Visit
Change at Week 20 (n=1481)
|
-1.68 mg/dL
Standard Deviation 2.573
|
|
C-Reactive Protein by Visit
Week 24 (n=1448)
|
0.19 mg/dL
Standard Deviation 0.802
|
|
C-Reactive Protein by Visit
Change at Week 24 (n=1448)
|
-1.74 mg/dL
Standard Deviation 2.608
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
ESR (mm/hr) is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis (RA) and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at each week minus the baseline value. A negative value in change from baseline indicates an improvement.
Outcome measures
| Measure |
Tocilizumab
n=1681 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Erythrocyte Sedimentation Rate by Visit
Baseline (n=1681)
|
39.20 mm/hr
Standard Deviation 26.843
|
|
Erythrocyte Sedimentation Rate by Visit
Week 4 (n=1642)
|
13.13 mm/hr
Standard Deviation 16.468
|
|
Erythrocyte Sedimentation Rate by Visit
Change at Week 4 (n=1642)
|
-26.07 mm/hr
Standard Deviation 21.863
|
|
Erythrocyte Sedimentation Rate by Visit
Week 8 (n=1603)
|
10.26 mm/hr
Standard Deviation 14.935
|
|
Erythrocyte Sedimentation Rate by Visit
Change at Week 8 (n=1603)
|
-28.93 mm/hr
Standard Deviation 23.945
|
|
Erythrocyte Sedimentation Rate by Visit
Week 12 (n=1567)
|
8.97 mm/hr
Standard Deviation 12.527
|
|
Erythrocyte Sedimentation Rate by Visit
Change at Week 12 (n=1567)
|
-30.02 mm/hr
Standard Deviation 24.543
|
|
Erythrocyte Sedimentation Rate by Visit
Week 16 (n=1520)
|
8.39 mm/hr
Standard Deviation 12.230
|
|
Erythrocyte Sedimentation Rate by Visit
Change at Week 16 (n=1520)
|
-30.43 mm/hr
Standard Deviation 24.703
|
|
Erythrocyte Sedimentation Rate by Visit
Week 20 (n=1474)
|
7.81 mm/hr
Standard Deviation 11.653
|
|
Erythrocyte Sedimentation Rate by Visit
Change at Week 20 (n=1474)
|
-31.01 mm/hr
Standard Deviation 24.648
|
|
Erythrocyte Sedimentation Rate by Visit
Week 24 (n=1463)
|
7.90 mm/hr
Standard Deviation 11.485
|
|
Erythrocyte Sedimentation Rate by Visit
Change at Week 24 (n=1463)
|
-31.01 mm/hr
Standard Deviation 24.796
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Outcome measures
| Measure |
Tocilizumab
n=1673 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
HAQ-DI Scores by Visit
Baseline (n=1673)
|
1.49 units on a scale
Standard Deviation 0.637
|
|
HAQ-DI Scores by Visit
Week 4 (n=1648)
|
1.27 units on a scale
Standard Deviation 0.665
|
|
HAQ-DI Scores by Visit
Change at Week 4 (n=1641)
|
-022 units on a scale
Standard Deviation 0.448
|
|
HAQ-DI Scores by Visit
Week 8 (n=1607)
|
1.12 units on a scale
Standard Deviation 0.677
|
|
HAQ-DI Scores by Visit
Change at Week 8 (n=1600)
|
-0.37 units on a scale
Standard Deviation 0.511
|
|
HAQ-DI Scores by Visit
Week 12 (n=1570)
|
1.03 units on a scale
Standard Deviation 0.684
|
|
HAQ-DI Scores by Visit
Change at Week 12 (n=1562)
|
-0.46 units on a scale
Standard Deviation 0.553
|
|
HAQ-DI Scores by Visit
Week 16 (n=1524)
|
0.99 units on a scale
Standard Deviation 0.690
|
|
HAQ-DI Scores by Visit
Change at Week 16 (n=1517)
|
-0.50 units on a scale
Standard Deviation 0.566
|
|
HAQ-DI Scores by Visit
Week 20 (n=1483)
|
0.95 units on a scale
Standard Deviation 0.687
|
|
HAQ-DI Scores by Visit
Change at Week 20 (n=1476)
|
-0.53 units on a scale
Standard Deviation 0.573
|
|
HAQ-DI Scores by Visit
Week 24 (n=1459)
|
0.92 units on a scale
Standard Deviation 0.697
|
|
HAQ-DI Scores by Visit
Change at Week 24 (n=1451)
|
-0.57 units on a scale
Standard Deviation 0.585
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \>3 points were considered clinically meaningful.
Outcome measures
| Measure |
Tocilizumab
n=1671 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Baseline (n=1671)
|
31.39 units on a scale
Standard Deviation 9.813
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Week 4 (n=1647)
|
34.17 units on a scale
Standard Deviation 10.398
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Change at Week 4 (1639)
|
2.79 units on a scale
Standard Deviation 8.064
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Week 8 (n=1608)
|
36.39 units on a scale
Standard Deviation 10.829
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Change at Week 8 (n=1598)
|
4.95 units on a scale
Standard Deviation 9.088
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Week 12 (n=1573)
|
37.69 units on a scale
Standard Deviation 11.096
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Change at Week 12 (n=1564)
|
6.19 units on a scale
Standard Deviation 9.751
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Week 16 (n=1529)
|
38.41 units on a scale
Standard Deviation 11.139
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Change at Week 16 (n=1521)
|
6.89 units on a scale
Standard Deviation 9.850
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Week 20 (n=1487)
|
39.21 units on a scale
Standard Deviation 11.123
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Change at Week 20 (n=1479)
|
7.66 units on a scale
Standard Deviation 10.306
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Week 24 (n=1465)
|
39.52 units on a scale
Standard Deviation 11.302
|
|
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Change at Week 24 (n=1457)
|
7.92 units on a scale
Standard Deviation 10.211
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The HAQ-DI scale ranges from 0 to 3, where higher scores represent higher disease activity. A score of \<0.5 represents clinical remission. A participant achieves a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of ≥0.22.
Outcome measures
| Measure |
Tocilizumab
n=1673 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 24, Remission (n=1459)
|
31.5 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Baseline, Remission (n=1673)
|
5.9 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 4, Remission (n=1648)
|
12.6 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 4, Clinically meaningful improvement (n=1641)
|
47.7 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 8, Remission (n=1607)
|
19.0 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 8, Clinically meaningful improvement (n=1600)
|
60.4 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 12, Remission (n=1570)
|
23.9 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 12 Clinically meaningful improvement (n=1562)
|
65.7 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 16, Remission (n=1524)
|
26.4 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 16 Clinically meaningful improvement (n=1517)
|
68.7 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 20, Remission (n=1483)
|
28.1 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 20 Clinically meaningful improvement (n=1476)
|
70.6 percentage of participants
|
|
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Week 24, Clinically meaningful improvement(n=1451)
|
72.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
FACIT-Fatigue 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 participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.
Outcome measures
| Measure |
Tocilizumab
n=1674 Participants
Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
|
|---|---|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Baseline (n=1674)
|
25.91 units on a scale
Standard Deviation 11.262
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Week 4 (n=1647)
|
30.95 units on a scale
Standard Deviation 11.133
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Change at Week 4 (n=1640)
|
5.01 units on a scale
Standard Deviation 8.916
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Week 8 (n=1611)
|
33.51 units on a scale
Standard Deviation 10.865
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Change at Week 8 (n=1605)
|
7.50 units on a scale
Standard Deviation 10.036
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Week 12 (n=1573)
|
34.98 units on a scale
Standard Deviation 11.069
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Change at Week 12 (n=1568)
|
8.86 units on a scale
Standard Deviation 10.463
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Week 16 (n=1529)
|
35.78 units on a scale
Standard Deviation 10.959
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Change at Week 16 (n=1524)
|
9.68 units on a scale
Standard Deviation 10.890
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Week 20 (n=1488)
|
36.45 units on a scale
Standard Deviation 10.848
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Change at Week 20 (n=1483)
|
10.31 units on a scale
Standard Deviation 10.947
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Week 24 (n=1466)
|
36.92 units on a scale
Standard Deviation 10.823
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Change at Week 24 (n=1461)
|
10.76 units on a scale
Standard Deviation 10.934
|
Adverse Events
Tocilizumab 8 mg/kg
Serious events: 131 serious events
Other events: 370 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tocilizumab 8 mg/kg
n=1681 participants at risk
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.36%
6/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Erysipelas
|
0.30%
5/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Bursitis infective
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Alveolar osteitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Appendicitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Arthritis bacterial
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Bordetella infection
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Cellulitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Folliculitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Furuncle
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Joint tuberculosis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Meningitis viral
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Postoperative abscess
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Rectal abscess
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Respiratory tract infection
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Scrotal abscess
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Sepsis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Skin infection
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Streptococcal infection
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Streptococcal sepsis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Tonsillitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Infections and infestations
Wound infection
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Food poisoning
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Nausea
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Gastrointestinal disorders
Vomiting
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Injury, poisoning and procedural complications
Fall
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Nervous system disorders
Sciatica
|
0.18%
3/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Nervous system disorders
Headache
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Nervous system disorders
Syncope
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Nervous system disorders
Ischaemic stroke
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Nervous system disorders
Migraine
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
General disorders
Chest pain
|
0.24%
4/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
General disorders
Ill-defined disorder
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
General disorders
Infusion related reaction
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
General disorders
Oedema peripheral
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
General disorders
Pyrexia
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
General disorders
Sudden death
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Vascular disorders
Deep vein thrombosis
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Vascular disorders
Aortic dissection
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Vascular disorders
Hypertension
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Vascular disorders
Peripheral ischaemia
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Vascular disorders
Rheumatoid vasculitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Vascular disorders
Thrombosis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Vascular disorders
Venous thrombosis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Vascular disorders
Venous thrombosis limb
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Cardiac disorders
Arrhythmia
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Cardiac disorders
Cardiac arrest
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Cardiac disorders
Cardiac failure
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Cardiac disorders
Coronary artery disease
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Psychiatric disorders
Depression
|
0.30%
5/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Psychiatric disorders
Anxiety
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Psychiatric disorders
Suicide attempt
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Eye disorders
Corneal perforation
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Eye disorders
Ulcerative keratitis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Immune system disorders
Hypersensitivity
|
0.12%
2/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Investigations
Blood pressure increased
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.06%
1/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
Other adverse events
| Measure |
Tocilizumab 8 mg/kg
n=1681 participants at risk
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.9%
116/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Investigations
Blood cholesterol increased
|
6.2%
105/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.0%
101/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
|
Nervous system disorders
Headache
|
5.5%
92/1681 • AE evaluation was done from the day of screening till the end of study at Week 24.
|
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 after the first publication or presentation that involves the overall study. 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