Trial Outcomes & Findings for A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (NCT NCT01245439)
NCT ID: NCT01245439
Last Updated: 2015-11-03
Results Overview
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the date of onset of the AE was on or after the date of first dose of study medication. AEs of special interest included Major Adverse Cardiovascular Events (MACE) (including strokes), infections, and infusion reactions. An AE was considered an infection if the preferred term was in the predefined infection AE group term. A serious infection was an infection which was also considered as an AE. An AE was considered an infusion reaction if it occurred during or within 24 hours of an infusion.
COMPLETED
PHASE3
65 participants
24 weeks
2015-11-03
Participant Flow
Participant milestones
| Measure |
Tocilizumab 8 Milligrams Per Kilogram (mg/kg)
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: The safety population consisted of all participants included in the study who received at least one dose of study medication and who had at least one post-baseline assessment of safety (that is post-baseline laboratory data, vital signs or adverse events).
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the date of onset of the AE was on or after the date of first dose of study medication. AEs of special interest included Major Adverse Cardiovascular Events (MACE) (including strokes), infections, and infusion reactions. An AE was considered an infection if the preferred term was in the predefined infection AE group term. A serious infection was an infection which was also considered as an AE. An AE was considered an infusion reaction if it occurred during or within 24 hours of an infusion.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events
AEs
|
90.8 percentage of participants
|
|
Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events
SAEs
|
9.2 percentage of participants
|
|
Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events
AEs of special interest
|
52.3 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Safety population
Participants who discontinued treatment due to any reason were included in this measure.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Percentage of Participants With All-Cause Discontinuation
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: Safety population
Elevations in ALT and AST could indicate hepatotoxicity.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 1) >1.5 ULN
|
1 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 1) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 1) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 2) >1.5 ULN
|
2 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 2) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 2) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 3) >1.5 ULN
|
8 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 3) >3 ULN
|
1 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 3) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 4) >1.5 ULN
|
5 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 4) >3 ULN
|
1 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 4) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 5) >1.5 ULN
|
7 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 5) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 5) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 6) >1.5 ULN
|
3 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 6) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 6) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 7) >1.5 ULN
|
10 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 7) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 7) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 8) >1.5 ULN
|
12 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 8) >3 ULN
|
1 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
ALT (Visit 8) >5 ULN
|
1 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 1) >1.5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 1) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 1) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 2) >1.5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 2) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 2) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 3) >1.5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 3) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 3) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 4) >1.5 ULN
|
1 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 4) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 4) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 5) >1.5 ULN
|
1 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 5) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 5) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 6) >1.5 ULN
|
1 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 6) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 6) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 7) >1.5 ULN
|
5 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 7) >3 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 7) >5 ULN
|
0 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 8) >1.5 ULN
|
1 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 8) >3 ULN
|
1 participants
|
|
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
AST (Visit 8) >5 ULN
|
1 participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: Safety population
Elevations in ALT and AST could indicate hepatotoxicity.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 5) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 1) 1.5 ULN
|
1.5 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 1) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 1) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 2) >1.5 ULN
|
3.1 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 2) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 2) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 3) >1.5 ULN
|
12.3 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 3) >3 ULN
|
1.5 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 3)> 5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 4) >1.5 ULN
|
7.7 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 4) >3 ULN
|
1.5 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 4)> 5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 5) >1.5 ULN
|
10.8 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 5) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 5) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 6)> 1.5 ULN
|
4.6 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 6) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 6) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 7) > 1.5 ULN
|
15.4 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 7) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 7) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 8) >1.5 ULN
|
18.5 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 8) >3 ULN
|
1.5 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
ALT (Visit 8) >5 ULN
|
1.5 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 1) >1.5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 1) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 1) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 2) >1.5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 2) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 2) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 3) >1.5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 3) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 3) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 4) >1.5 ULN
|
4 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 4) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 4) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 5) >1.5 ULN
|
4.2 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 5) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 6) >1.5 ULN
|
1.5 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 6) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 6) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 7) >1.5 ULN
|
7.7 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 7) >3 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 7) >5 ULN
|
0.0 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 8) >1.5 ULN
|
1.5 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 8) >3 ULN
|
1.5 percentage of participants
|
|
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
AST (Visit 8) >5 ULN
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)Population: Safety population
A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Percentage of Participants With Serious Infections
Visit 3
|
1.5 percentage of participants
|
|
Percentage of Participants With Serious Infections
Visit 4
|
1.5 percentage of participants
|
|
Percentage of Participants With Serious Infections
Visit 6
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)Population: Safety population
A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Number of Participants With Serious Infections
Visit 3
|
1 participants
|
|
Number of Participants With Serious Infections
Visit 4
|
1 participants
|
|
Number of Participants With Serious Infections
Visit 6
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety population
Elevations in ALT and AST could indicate hepatotoxicity. These enzymes were measured as International Units per Liter (IU/L). The change from baseline was calculated as: baseline value minus the highest value observed post-baseline for each enzyme.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Change From Baseline to Highest Values for ALT and AST
ALT
|
28.9 IU/L
Standard Deviation 25.2
|
|
Change From Baseline to Highest Values for ALT and AST
AST
|
21.3 IU/L
Standard Deviation 37.9
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety population; number of participants analyzed signifies participants who were evaluable for this outcome.
Elevations in LDL and total cholesterol could lead to heart disease. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline and was measured as milligrams per deciliter (mg/dL).
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=61 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol
LDL
|
29.1 mg/dL
Standard Deviation 27.2
|
|
Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol
Total Cholesterol
|
39.8 mg/dL
Standard Deviation 29.7
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety population
ANC is a measure of number of neutrophil granulocytes. An ANC less than 500 cells per microliter (cells/µL) is defined as neutropenia and significantly increases risk of infection. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline. ANC was measured in cells/µL.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC)
|
-3.04 cells/µL
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: Safety population; Number (n) equals (=) number of participants analyzed at the specified visit for the given parameter.
ATP III guidelines classify LDL cholesterol \>160 mg/dL, Total cholesterol \>240 mg/dL, High Density Lipoprotein (HDL) \>60 mg/dL and Triglycerides (TG) \>199 as elevated.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 1 LDL >160 (n=62)
|
3 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 1 Total Cholesterol >240 (n=62)
|
5 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 1 HDL >60 (n=63)
|
20 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 1 TG>199 (n=63)
|
7 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 2 LDL >160 (n=57)
|
1 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 2 Total Cholesterol >240 (n=59)
|
3 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 2 HDL >60 (n=62)
|
17 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 2 TG>199 (n=59)
|
9 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 3 LDL >160 (n=60)
|
6 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 3 Total Cholesterol >240 (n=64)
|
7 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 3 HDL >60 (n=62)
|
25 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 3 TG>199 (n=63)
|
14 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 4 LDL >160 (n=55)
|
5 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 4 Total Cholesterol >240 (n=61)
|
11 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 4 HDL >60 (n=58)
|
24 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 4 TG>199 (n=58)
|
12 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 5 LDL >160 (n=62)
|
7 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 5 Total Cholesterol >240 (n=63)
|
10 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 5 HDL >60 (n=63)
|
29 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 5 TG>199 (n=63)
|
11 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 6 LDL >160 (n=59)
|
5 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 6 Total Cholesterol >240 (n=62)
|
10 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 6 HDL >60 (n=62)
|
29 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 6 TG>199 (n=62)
|
13 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 7 LDL >160 (n=62)
|
5 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 7 Total Cholesterol >240 (n=62)
|
7 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 7 HDL >60 (n=62)
|
26 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 7 TG>199 (n=62)
|
10 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 8 LDL >160 (n=61)
|
8 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 8 Total Cholesterol >240 (n=62)
|
12 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 8 HDL >60 (n=62)
|
30 participants
|
|
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
Visit 8 TG>199 (n=61)
|
8 participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: Safety population; n = number of participants analyzed at the specified visit for the given parameter.
ATP III guidelines classify LDL cholesterol \>160 mg/dL , Total cholesterol \>240 mg/dL, HDL \>60 mg/dL and TG \>199 as elevated.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 7 TG>199 (n=62)
|
16.1 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 8 LDL >160 (n=61)
|
13.1 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 1 LDL >160 (n=62)
|
4.8 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 1 Total Cholesterol >240 (n=62)
|
8.1 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 1 HDL >60 (n=63)
|
31.7 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 1 TG>199 (n=63)
|
11.1 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 2 LDL >160 (n=57)
|
1.8 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 2 Total Cholesterol >240 (n=59)
|
5.1 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 2 HDL >60 (n=62)
|
27.4 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 2 TG>199 (n=59)
|
15.3 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 3 LDL >160 (n=60)
|
10.0 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 3 Total Cholesterol >240 (n=64)
|
10.9 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 3 HDL >60 (n=62)
|
40.3 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 3 TG>199 (n=63)
|
22.2 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 4 LDL >160 (n=55)
|
7.3 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 4 Total Cholesterol >240 (n=61)
|
18.0 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 4 HDL >60 (n=58)
|
41.4 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 4 TG>199 (n=58)
|
20.7 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 5 LDL >160 (n=62)
|
11.3 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 5 Total Cholesterol >240 (n=63)
|
15.9 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 5 HDL >60 (n=63)
|
46.0 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 5 TG>199 (n=63)
|
17.5 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 6 LDL >160 (n=59)
|
8.5 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 6 Total Cholesterol >240 (n=62)
|
16.1 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 6 HDL >60 (n=62)
|
46.8 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 6 TG>199 (n=62)
|
21.0 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 7 LDL >160 (n=62)
|
8.1 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 7 Total Cholesterol >240 (n=62)
|
11.3 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 7 HDL >60 (n=62)
|
41.9 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 8 Total Cholesterol >240 (n=62)
|
19.4 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 8 HDL >60 (n=62)
|
48.4 percentage of participants
|
|
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
Visit 8 TG>199 (n=61)
|
13.1 percentage of participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: Intent- to- Treat (ITT) Population: all enrolled participants who received at least one dose of study medication. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category
The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of less than (\<) 2.6 represents clinical remission, a score of: \<3.2 represents low disease activity (LDA), and a score of \> 5.1 represents severe disease. A reduction from previous visit of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit
Visit 1 - Visit 2 (n=55)
|
0 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit
Visit 2 - Visit 3 (n=55)
|
48 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit
Visit 3 - Visit 4 (n=54)
|
18 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit
Visit 4 - Visit 5 (n=53)
|
7 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit
Visit 5 - Visit 6 (n=54)
|
2 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit
Visit 6 - Visit 7 (n=53)
|
4 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit
Visit 7 - Visit 8 (n=53)
|
1 participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \< 3.2 represents LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit
Visit 1 - Visit 2 (n=55)
|
0.0 percentage of participants
|
|
Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit
Visit 2 - Visit 3 (n=55)
|
87.3 percentage of participants
|
|
Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit
Visit 3 - Visit 4 (n=54)
|
33.3 percentage of participants
|
|
Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit
Visit 4 - Visit 5 (n=53)
|
13.2 percentage of participants
|
|
Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit
Visit 5 - Visit 6 (n=54)
|
3.7 percentage of participants
|
|
Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit
Visit 6 - Visit 7 (n=53)
|
7.5 percentage of participants
|
|
Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit
Visit 7 - Visit 8 (n=53)
|
1.9 percentage of participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 represents LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Number of Participants Who Achieved LDA By Visit
Visit 1 (n=60)
|
0 participants
|
|
Number of Participants Who Achieved LDA By Visit
Visit 2 (n=58)
|
1 participants
|
|
Number of Participants Who Achieved LDA By Visit
Visit 3 (n=57)
|
32 participants
|
|
Number of Participants Who Achieved LDA By Visit
Visit 4 (n=56)
|
45 participants
|
|
Number of Participants Who Achieved LDA By Visit
Visit 5 (n=57)
|
48 participants
|
|
Number of Participants Who Achieved LDA By Visit
Visit 6 (n=57)
|
50 participants
|
|
Number of Participants Who Achieved LDA By Visit
Visit 7 (n=54)
|
51 participants
|
|
Number of Participants Who Achieved LDA By Visit
Visit 8 (n=60)
|
55 participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.
TThe DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 represents LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Percentage of Participants Who Achieved LDA By Visit
Visit 1 (n=60)
|
0.0 percentage of participants
|
|
Percentage of Participants Who Achieved LDA By Visit
Visit 2 (n=58)
|
1.7 percentage of participants
|
|
Percentage of Participants Who Achieved LDA By Visit
Visit 3 (n=57)
|
56.1 percentage of participants
|
|
Percentage of Participants Who Achieved LDA By Visit
Visit 4 (n=56)
|
80.4 percentage of participants
|
|
Percentage of Participants Who Achieved LDA By Visit
Visit 5 (n=57)
|
84.2 percentage of participants
|
|
Percentage of Participants Who Achieved LDA By Visit
Visit 6 (n=57)
|
87.7 percentage of participants
|
|
Percentage of Participants Who Achieved LDA By Visit
Visit 7 (n=54)
|
94.4 percentage of participants
|
|
Percentage of Participants Who Achieved LDA By Visit
Visit 8 (n=60)
|
91.7 percentage of participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT Population; Number of participants analyzed = participants who were evaluable for this outcome
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
Visit 1
|
0.0 Percentage of participants
|
|
Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
Visit 2
|
1.7 Percentage of participants
|
|
Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
Visit 3
|
51.7 Percentage of participants
|
|
Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
Visit 4
|
28.3 Percentage of participants
|
|
Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
Visit 5
|
10.0 Percentage of participants
|
|
Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
Visit 6
|
1.7 Percentage of participants
|
|
Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
Visit 7
|
1.7 Percentage of participants
|
|
Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
Visit 8
|
1.7 Percentage of participants
|
|
Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
Never Acheived LDA
|
3.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Number of Participants Who Achieved Remission (DAS28) By Visit
Visit (n=60)
|
0 participants
|
|
Number of Participants Who Achieved Remission (DAS28) By Visit
Visit 2 (n=58)
|
0 participants
|
|
Number of Participants Who Achieved Remission (DAS28) By Visit
Visit 3 (n=57)
|
24 participants
|
|
Number of Participants Who Achieved Remission (DAS28) By Visit
Visit 4 (n=56)
|
35 participants
|
|
Number of Participants Who Achieved Remission (DAS28) By Visit
Visit 5 (n=57)
|
43 participants
|
|
Number of Participants Who Achieved Remission (DAS28) By Visit
Visit 6 (n=57)
|
46 participants
|
|
Number of Participants Who Achieved Remission (DAS28) By Visit
Visit 7 (n=54)
|
45 participants
|
|
Number of Participants Who Achieved Remission (DAS28) By Visit
Visit 8 (n=60)
|
51 participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Percentage of Participants Who Achieved Remission (DAS28) At Every Visit
Visit 1 (n=60)
|
0.0 percentage of participants
|
|
Percentage of Participants Who Achieved Remission (DAS28) At Every Visit
Visit 2 (n=58)
|
0.0 percentage of participants
|
|
Percentage of Participants Who Achieved Remission (DAS28) At Every Visit
Visit 3 (n=57)
|
42.1 percentage of participants
|
|
Percentage of Participants Who Achieved Remission (DAS28) At Every Visit
Visit 4 (n=56)
|
62.5 percentage of participants
|
|
Percentage of Participants Who Achieved Remission (DAS28) At Every Visit
Visit 5 (n=57)
|
75.4 percentage of participants
|
|
Percentage of Participants Who Achieved Remission (DAS28) At Every Visit
Visit 6 (n=57)
|
80.7 percentage of participants
|
|
Percentage of Participants Who Achieved Remission (DAS28) At Every Visit
Visit 7 (n=54)
|
83.3 percentage of participants
|
|
Percentage of Participants Who Achieved Remission (DAS28) At Every Visit
Visit 8 (n=60)
|
85.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Percentage of Participants Achieving Their First Remission Status By Visit
In Visit 3
|
40.0 Percentage of participants
|
|
Percentage of Participants Achieving Their First Remission Status By Visit
In Visit 4
|
25.0 Percentage of participants
|
|
Percentage of Participants Achieving Their First Remission Status By Visit
In Visit 5
|
15.0 Percentage of participants
|
|
Percentage of Participants Achieving Their First Remission Status By Visit
In Visit 6
|
5.0 Percentage of participants
|
|
Percentage of Participants Achieving Their First Remission Status By Visit
In Visit 7
|
3.3 Percentage of participants
|
|
Percentage of Participants Achieving Their First Remission Status By Visit
In Visit 8
|
3.3 Percentage of participants
|
|
Percentage of Participants Achieving Their First Remission Status By Visit
Never Achieved Remission
|
8.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population. n = participants who were evaluable for specified category
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Disease Activity Score as Measured By DAS28 at Each Visit
Visit 1 (n=60)
|
5.6 units on a scale
Standard Deviation 0.9
|
|
Disease Activity Score as Measured By DAS28 at Each Visit
Visit 2 (n=58)
|
5.6 units on a scale
Standard Deviation 1.1
|
|
Disease Activity Score as Measured By DAS28 at Each Visit
Visit 3 (n=57)
|
3.1 units on a scale
Standard Deviation 1.4
|
|
Disease Activity Score as Measured By DAS28 at Each Visit
Visit 4 (n=56)
|
2.3 units on a scale
Standard Deviation 1.0
|
|
Disease Activity Score as Measured By DAS28 at Each Visit
Visit 5 (n=57)
|
2.0 units on a scale
Standard Deviation 1.3
|
|
Disease Activity Score as Measured By DAS28 at Each Visit
Visit 6 (n=57)
|
1.8 units on a scale
Standard Deviation 1.1
|
|
Disease Activity Score as Measured By DAS28 at Each Visit
Visit 7 (n=54)
|
1.7 units on a scale
Standard Deviation 1.0
|
|
Disease Activity Score as Measured By DAS28 at Each Visit
Visit 8 (n=60)
|
1.6 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population; number of participants analyzed = participants who were evaluable for this outcome.
ACR20/50/70/90 response: greater than or equal to (≥) 20/50/70/90 percent (%) improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 2 to Visit 3 ACR20
|
20 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 2 to Visit 3 ACR50
|
12 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 2 to Visit 3 ACR70
|
5 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 2 to Visit 3 ACR90
|
0 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 3 to Visit 4 ACR20
|
37 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 3 to Visit 4 ACR50
|
25 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 3 to Visit 4 ACR70
|
14 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 3 to Visit 4 ACR90
|
1 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 4 to Visit 5 ACR20
|
33 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 4 to Visit 5 ACR50
|
26 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 4 to Visit 5 ACR70
|
18 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 4 to Visit 5 ACR90
|
4 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 5 to Visit 6 ACR20
|
32 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 5 to Visit 6 ACR50
|
26 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 5 to Visit 6 ACR70
|
20 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 5 to Visit 6 ACR90
|
7 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 6 to Visit 7 ACR20
|
27 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 6 to Visit 7 ACR50
|
23 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 6 to Visit 7 ACR70
|
17 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 6 to Visit 7 ACR90
|
4 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 7 to Visit 8 ACR20
|
32 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 7 to Visit 8 ACR50
|
28 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 7 to Visit 8 ACR70
|
18 participants
|
|
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
Visit 7 to Visit 8 ACR90
|
6 participants
|
SECONDARY outcome
Timeframe: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population; number of participants analyzed = participants who were evaluable for this outcome.
ACR20/50/70/90 response: ≥ 20/50/70/90 % improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit. .
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 2 to Visit 3 ACR90
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 3 to Visit 4 ACR20
|
61.7 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 3 to Visit 4 ACR50
|
41.7 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 3 to Visit 4 ACR70
|
23.3 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 3 to Visit 4 ACR90
|
1.7 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 3 to Visit 5 ACR20
|
55.0 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 4 to Visit 5 ACR50
|
43.3 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 4 to Visit 5 ACR70
|
30.0 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 4 to Visit 5 ACR90
|
6.7 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 5 to Visit 6 ACR20
|
53.3 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 5 to Visit 6 ACR50
|
43.3 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 5 to Visit 6 ACR70
|
33.3 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 5 to Visit 6 ACR90
|
11.7 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 6 to Visit 7 ACR20
|
45.0 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 6 to Visit 7 ACR50
|
38.3 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 6 to Visit 7 ACR70
|
28.3 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 6 to Visit 7 ACR90
|
6.7 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 7 to Visit 8 ACR20
|
53.3 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 7 to Visit 8 ACR50
|
46.7 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 7 to Visit 8 ACR70
|
30.0 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 7 to Visit 8 ACR90
|
10.0 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 2 to Visit 3 ACR20
|
33.3 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 2 to Visit 3 ACR50
|
20.0 Percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
Visit 2 to Visit 3 ACR70
|
8.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.
CRP is an inflammatory marker used to measure inflammation in RA and is measured as mg/dL.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=59 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
C-Reactive Protein Levels
Visit 1 (n=59)
|
3.5 mg/dL
Standard Deviation 6.2
|
|
C-Reactive Protein Levels
Visit 2 (n=53)
|
2.3 mg/dL
Standard Deviation 3.2
|
|
C-Reactive Protein Levels
Visit 3 (n=53)
|
1.0 mg/dL
Standard Deviation 2.2
|
|
C-Reactive Protein Levels
Visit 4 (n=58)
|
0.6 mg/dL
Standard Deviation 0.9
|
|
C-Reactive Protein Levels
Visit 5 (n=57)
|
0.6 mg/dL
Standard Deviation 1.3
|
|
C-Reactive Protein Levels
Visit 6 (n=58)
|
1.0 mg/dL
Standard Deviation 4.2
|
|
C-Reactive Protein Levels
Visit 7 (n=52)
|
0.8 mg/dL
Standard Deviation 1.6
|
|
C-Reactive Protein Levels
Visit 8 (n=58)
|
0.5 mg/dL
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category
ESR is an inflammatory marker used to measure inflammation in RA and is measured as millimeters per hour (mm/hr).
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=60 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Erythrocyte Sedimentation Rate
Visit 1 (n=60)
|
35.4 mm/hr
Standard Deviation 22.9
|
|
Erythrocyte Sedimentation Rate
Visit 2 (n=58)
|
36.4 mm/hr
Standard Deviation 24.1
|
|
Erythrocyte Sedimentation Rate
Visit 3 (n=57)
|
12.3 mm/hr
Standard Deviation 13.3
|
|
Erythrocyte Sedimentation Rate
Visit 4 (n=56)
|
8.0 mm/hr
Standard Deviation 9.3
|
|
Erythrocyte Sedimentation Rate
Visit 5 (n=58)
|
7.8 mm/hr
Standard Deviation 9.4
|
|
Erythrocyte Sedimentation Rate
Visit 6 (n=57)
|
7.8 mm/hr
Standard Deviation 8.2
|
|
Erythrocyte Sedimentation Rate
Visit 7 (n=54)
|
6.3 mm/hr
Standard Deviation 5.4
|
|
Erythrocyte Sedimentation Rate
Visit 8 (n=60)
|
8.6 mm/hr
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population
Participants were asked to classify 28 joints as tender or not tender and swollen or not swollen to count the total number of tender and swollen joints by visit.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Mean Number of Tender and Swollen Joints
Visit 5 TJC
|
2.7 joints
Standard Deviation 4.7
|
|
Mean Number of Tender and Swollen Joints
Visit 1 TJC
|
15.1 joints
Standard Deviation 9.6
|
|
Mean Number of Tender and Swollen Joints
Visit 1 SJC
|
5.5 joints
Standard Deviation 4.7
|
|
Mean Number of Tender and Swollen Joints
Visit 2 TJC
|
16.0 joints
Standard Deviation 11.5
|
|
Mean Number of Tender and Swollen Joints
Visit 2 SJC
|
5.7 joints
Standard Deviation 5.2
|
|
Mean Number of Tender and Swollen Joints
Visit 3 TJC
|
6.1 joints
Standard Deviation 7.4
|
|
Mean Number of Tender and Swollen Joints
Visit 3 SJC
|
1.9 joints
Standard Deviation 3.2
|
|
Mean Number of Tender and Swollen Joints
Visit 4 TJC
|
3.3 joints
Standard Deviation 4.8
|
|
Mean Number of Tender and Swollen Joints
Visit 4 SJC
|
0.8 joints
Standard Deviation 1.6
|
|
Mean Number of Tender and Swollen Joints
Visit 5 SJC
|
0.5 joints
Standard Deviation 1.1
|
|
Mean Number of Tender and Swollen Joints
Visit 6 TJC
|
2.0 joints
Standard Deviation 4.4
|
|
Mean Number of Tender and Swollen Joints
Visit 6 SJC
|
0.5 joints
Standard Deviation 1.3
|
|
Mean Number of Tender and Swollen Joints
Visit 7 TJC
|
1.8 joints
Standard Deviation 3.2
|
|
Mean Number of Tender and Swollen Joints
Visit 7 SJC
|
0.6 joints
Standard Deviation 1.6
|
|
Mean Number of Tender and Swollen Joints
Visit 8 TJC
|
1.3 joints
Standard Deviation 2.6
|
|
Mean Number of Tender and Swollen Joints
Visit 8 SJC
|
0.4 joints
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population
VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 1 IN
|
70.1 mm
Standard Deviation 16.0
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 2 PT
|
70.3 mm
Standard Deviation 17.7
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 2 IN
|
68.3 mm
Standard Deviation 16.7
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 3 PT
|
41.8 mm
Standard Deviation 24.7
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 3 IN
|
33.3 mm
Standard Deviation 21.5
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 4 PT
|
25.3 mm
Standard Deviation 20.1
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 4 IN
|
20.6 mm
Standard Deviation 14.1
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 5 PT
|
24.1 mm
Standard Deviation 20.6
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 5 IN
|
16.9 mm
Standard Deviation 13.8
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 6 PT
|
23.1 mm
Standard Deviation 21.9
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 6 IN
|
16.9 mm
Standard Deviation 16.7
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 7 PT
|
18.3 mm
Standard Deviation 18.6
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 7 IN
|
14.9 mm
Standard Deviation 14.4
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 8 PT
|
16.2 mm
Standard Deviation 17.3
|
|
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
Visit 8 IN
|
12.5 mm
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population
VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Participant's Assessment of Pain
Visit 2
|
66.4 mm
Standard Deviation 20.8
|
|
Participant's Assessment of Pain
Visit 3
|
38.8 mm
Standard Deviation 26.7
|
|
Participant's Assessment of Pain
Visit 4
|
25.6 mm
Standard Deviation 22.6
|
|
Participant's Assessment of Pain
Visit 5
|
22.7 mm
Standard Deviation 21.8
|
|
Participant's Assessment of Pain
Visit 6
|
23.0 mm
Standard Deviation 23.9
|
|
Participant's Assessment of Pain
Visit 7
|
17.8 mm
Standard Deviation 17.9
|
|
Participant's Assessment of Pain
Visit 8
|
15.3 mm
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)Population: ITT population
The Stanford HAQ disability index is a participant completed questionnaire specific for RA. It consists of 20 questions referring to 8 component sections: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in validated translation into the local languages at the participating sites and was scored. Every question in each section was scored at a scale from 0 to 3 by the participant where 0 = able to perform the activity without any difficulty and 3 = unable to perform the activity. General score was calculated as an average of the 8 sections.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=65 Participants
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Health Assessment Questionnaire Score (General Score)
Visit 2
|
1.3 units on a scale
Standard Deviation 0.7
|
|
Health Assessment Questionnaire Score (General Score)
Visit 3
|
0.8 units on a scale
Standard Deviation 0.8
|
|
Health Assessment Questionnaire Score (General Score)
Visit 4
|
0.6 units on a scale
Standard Deviation 0.7
|
|
Health Assessment Questionnaire Score (General Score)
Visit 5
|
0.5 units on a scale
Standard Deviation 0.7
|
|
Health Assessment Questionnaire Score (General Score)
Visit 6
|
0.4 units on a scale
Standard Deviation 0.6
|
|
Health Assessment Questionnaire Score (General Score)
Visit 7
|
0.4 units on a scale
Standard Deviation 0.7
|
|
Health Assessment Questionnaire Score (General Score)
Visit 8
|
0.4 units on a scale
Standard Deviation 0.6
|
Adverse Events
Tocilizumab 8 mg/kg
Serious adverse events
| Measure |
Tocilizumab 8 mg/kg
n=65 participants at risk
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Vascular disorders
Hypertension, tremor, acute infusion reaction
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
|
Infections and infestations
Pneumonia (community acquired pneumonia)
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
|
Infections and infestations
Pneumonia (suspected)
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
|
Blood and lymphatic system disorders
Vasculit (splinter hemorrhage, fingertip hemorrhage)
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
|
General disorders
Fatigue
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
|
Investigations
Hypercholesterolaemia, Hypertriglyceridaemia, LDL-Hyperlipidaemia
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
|
Investigations
Hypertriglyceridaemia
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
|
Investigations
Elevated levels of ALT
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
|
Cardiac disorders
Cardiac pain (angina pectoris)
|
1.5%
1/65 • From the date of first infusion to 24 weeks
|
Other adverse events
| Measure |
Tocilizumab 8 mg/kg
n=65 participants at risk
Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
|
|---|---|
|
Investigations
Hypercholesterolaemia
|
16.9%
11/65 • From the date of first infusion to 24 weeks
|
|
Investigations
Hypertriglyceridaemia
|
10.8%
7/65 • From the date of first infusion to 24 weeks
|
|
Hepatobiliary disorders
Elevated ALT <45
|
16.9%
11/65 • From the date of first infusion to 24 weeks
|
|
Hepatobiliary disorders
Elevated ALT 1.5- 3 ULN
|
21.5%
14/65 • From the date of first infusion to 24 weeks
|
|
Hepatobiliary disorders
Elevated AST <60
|
13.8%
9/65 • From the date of first infusion to 24 weeks
|
|
Hepatobiliary disorders
Elevated AST 1.5 - 3ULN
|
6.2%
4/65 • From the date of first infusion to 24 weeks
|
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