Trial Outcomes & Findings for An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis (NCT NCT01575769)
NCT ID: NCT01575769
Last Updated: 2018-02-09
Results Overview
AE: unfavorable and unintended sign, symptom, or disease associated with use of treatment, regardless of treatment relation. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from treatment were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Severe AE: AE that caused inability to work or perform normal daily activity. AEs of special interest: Serious infections (including opportunistic infections), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related AE, Malignant neoplasms, Anaphylaxis event, Demyelination-related events, Stroke, Spontaneous or serious bleeding, Serious/medically significant hepatic events. Any AE included serious and non-serious AE.
TERMINATED
PHASE3
41 participants
Baseline to 12 weeks after last actual study medication (up to 101 weeks)
2018-02-09
Participant Flow
Participants who completed Visit 33 (Week 104) of the core study WA19977 (NCT00988221) with at least juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 clinical response were eligible to continue the study therapy within this long-term extension study in Russia and Poland.
Participant milestones
| Measure |
Tocilizumab
Participants received tocilizumab 8 milligrams per kilograms (mg/kg) via intravenous (IV) infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Tocilizumab
Participants received tocilizumab 8 milligrams per kilograms (mg/kg) via intravenous (IV) infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Study terminated by sponsor
|
40
|
Baseline Characteristics
An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Age, Continuous
|
12.0 years
STANDARD_DEVIATION 4.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks after last actual study medication (up to 101 weeks)Population: Safety population
AE: unfavorable and unintended sign, symptom, or disease associated with use of treatment, regardless of treatment relation. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from treatment were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Severe AE: AE that caused inability to work or perform normal daily activity. AEs of special interest: Serious infections (including opportunistic infections), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related AE, Malignant neoplasms, Anaphylaxis event, Demyelination-related events, Stroke, Spontaneous or serious bleeding, Serious/medically significant hepatic events. Any AE included serious and non-serious AE.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs)
Any AEs
|
56.1 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Any Treatment Related AEs
|
29.3 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Any SAEs
|
7.3 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Any Severe AEs
|
2.4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Any Life Threatening AEs
|
0.0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
AEs of Special Interest
|
0.0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
AE Leading to Dosage Modification/Interruption
|
22.0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Withdrawal Due to AEs
|
2.4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Withdrawal Due to SAEs
|
2.4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Withdrawal Due to AEs of Special Interest
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)Population: Safety population
JIA ACR30 response was defined as 3 of any 6 core outcome variables improved by at least 30% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: Physician global assessment (PGA) of disease activity using Visual Analog Scale (VAS) from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); Patient/parent global assessment (PtGA) of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and Erythrocyte Sedimentation Rate (ESR).
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Percentage of Participants With JIA ACR 30 Response at Weeks 12, 24 and End of Follow Up
Baseline
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
|
Percentage of Participants With JIA ACR 30 Response at Weeks 12, 24 and End of Follow Up
Week 12
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
|
Percentage of Participants With JIA ACR 30 Response at Weeks 12, 24 and End of Follow Up
Week 24
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
|
Percentage of Participants With JIA ACR 30 Response at Weeks 12, 24 and End of Follow Up
Follow up
|
80.5 percentage of participants
Interval 65.1 to 91.2
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)Population: Safety population
JIA ACR50 response was defined as 3 of any 6 core outcome variables improved by at least 50% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Percentage of Participants With JIA ACR 50 Response at Weeks 12, 24 and End of Follow up
Baseline
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
|
Percentage of Participants With JIA ACR 50 Response at Weeks 12, 24 and End of Follow up
Week 12
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
|
Percentage of Participants With JIA ACR 50 Response at Weeks 12, 24 and End of Follow up
Week 24
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
|
Percentage of Participants With JIA ACR 50 Response at Weeks 12, 24 and End of Follow up
Follow up
|
80.5 percentage of participants
Interval 65.1 to 91.2
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)Population: Safety population
JIA ACR70 response was defined as 3 of any 6 core outcome variables improved by at least 70% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Percentage of Participants With JIA ACR 70 Response at Weeks 12, 24 and End of Follow up
Baseline
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
|
Percentage of Participants With JIA ACR 70 Response at Weeks 12, 24 and End of Follow up
Week 12
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
|
Percentage of Participants With JIA ACR 70 Response at Weeks 12, 24 and End of Follow up
Week 24
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
|
Percentage of Participants With JIA ACR 70 Response at Weeks 12, 24 and End of Follow up
Follow up
|
78.0 percentage of participants
Interval 62.4 to 89.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)Population: Safety population
JIA ACR90 response was defined as 3 of any 6 core outcome variables improved by at least 90% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Percentage of Participants With JIA ACR 90 Response at Weeks 12, 24 and End of Follow up
Baseline
|
73.2 percentage of participants
Interval 57.1 to 85.8
|
|
Percentage of Participants With JIA ACR 90 Response at Weeks 12, 24 and End of Follow up
Week 12
|
78.0 percentage of participants
Interval 62.4 to 89.4
|
|
Percentage of Participants With JIA ACR 90 Response at Weeks 12, 24 and End of Follow up
Week 24
|
80.5 percentage of participants
Interval 65.1 to 91.2
|
|
Percentage of Participants With JIA ACR 90 Response at Weeks 12, 24 and End of Follow up
Follow up
|
75.6 percentage of participants
Interval 59.7 to 87.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)Population: Safety population
Criteria for Inactive Disease: 1) No joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both), 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal ESR (less than \[\<\] 20 millimeters per hour \[mm/hour\]), and 4) PGA of disease activity using VAS indicated no disease activity (where no disease activity is considered to be a score less than or equal to \[≤\]10 mm on a 100 mm VAS where left end of line 0 \[inactive arthritis\] to right end of line 100 \[very active arthritis\]).
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Percentage of Participants With Inactive Disease at Week 12, 24 and End of Follow up
Baseline
|
63.4 percentage of participants
Interval 46.9 to 77.9
|
|
Percentage of Participants With Inactive Disease at Week 12, 24 and End of Follow up
Week 12
|
65.9 percentage of participants
Interval 49.4 to 79.9
|
|
Percentage of Participants With Inactive Disease at Week 12, 24 and End of Follow up
Week 24
|
75.6 percentage of participants
Interval 59.7 to 87.6
|
|
Percentage of Participants With Inactive Disease at Week 12, 24 and End of Follow up
Follow up
|
61.0 percentage of participants
Interval 44.5 to 75.8
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)Population: Safety population
Clinical remission: inactive disease for minimum of 6 continuous months while on medication (Level 1); off oral corticosteroid medications but still on tocilizumab (Level 2); off both methotrexate and oral corticosteroids but still on tocilizumab (Level 3); or off all anti-arthritis medications-oral corticosteroids, methotrexate, non-steroidal anti-inflammatory drugs but still on tocilizumab (Level 4). Inactive disease: No joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to sJIA; Normal ESR (\<20 mm/hour); PGA of disease activity indicated no disease activity (score ≤10 mm on a 100 mm VAS where 0 \[inactive arthritis\] and 100 \[very active arthritis\]). Overall percentage of participants with clinical remission (any level) are reported.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Percentage of Participants With Clinical Remission at Week 12, 24 and End of Follow up
Baseline
|
43.9 percentage of participants
Interval 28.5 to 60.3
|
|
Percentage of Participants With Clinical Remission at Week 12, 24 and End of Follow up
Week 12
|
46.3 percentage of participants
Interval 30.7 to 62.6
|
|
Percentage of Participants With Clinical Remission at Week 12, 24 and End of Follow up
Week 24
|
48.8 percentage of participants
Interval 32.9 to 64.9
|
|
Percentage of Participants With Clinical Remission at Week 12, 24 and End of Follow up
Follow up
|
46.3 percentage of participants
Interval 30.7 to 62.6
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
Joint with active arthritis was defined as a joint with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Baseline (n=41)
|
1.4 Joints
Standard Deviation 2.68
|
|
Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 12 (n=41)
|
-0.1 Joints
Standard Deviation 1.70
|
|
Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 24 (n=41)
|
-0.4 Joints
Standard Deviation 4.56
|
|
Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 36 (n=35)
|
-1.4 Joints
Standard Deviation 2.80
|
|
Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 48 (n=22)
|
-1.7 Joints
Standard Deviation 3.34
|
|
Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 60 (n=17)
|
0.4 Joints
Standard Deviation 8.17
|
|
Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 72 (n=10)
|
1.9 Joints
Standard Deviation 7.52
|
|
Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 84 (n=7)
|
3.9 Joints
Standard Deviation 11.55
|
|
Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Follow Up (n=33)
|
1.2 Joints
Standard Deviation 4.14
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The maximum number of joints with limitation of movement is 67 and these were defined as those with 'limitation of motion'.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Baseline (n=41)
|
3.5 Joints
Standard Deviation 6.30
|
|
Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 12 (n=41)
|
-0.6 Joints
Standard Deviation 2.23
|
|
Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 24 (n=41)
|
-0.9 Joints
Standard Deviation 2.75
|
|
Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 36 (n=35)
|
-1.3 Joints
Standard Deviation 3.14
|
|
Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 48 (n=22)
|
-1.5 Joints
Standard Deviation 4.21
|
|
Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 60 (n=17)
|
-1.2 Joints
Standard Deviation 5.10
|
|
Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 72 (n=10)
|
0.0 Joints
Standard Deviation 1.83
|
|
Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 84 (n=7)
|
0.7 Joints
Standard Deviation 3.09
|
|
Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Follow Up (n=33)
|
2.6 Joints
Standard Deviation 5.80
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The physician provides a rating of the participant's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end represents 'arthritis very active'. A higher score indicates more disease activity. A negative change score indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Baseline (n=41)
|
4.5 mm
Standard Deviation 4.99
|
|
Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 12 (n=41)
|
1.0 mm
Standard Deviation 5.66
|
|
Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 24 (n=41)
|
0.1 mm
Standard Deviation 4.97
|
|
Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 36 (n=35)
|
-0.6 mm
Standard Deviation 4.29
|
|
Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 48 (n=22)
|
-0.4 mm
Standard Deviation 5.80
|
|
Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 60 (n=17)
|
0.4 mm
Standard Deviation 6.52
|
|
Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 72 (n=10)
|
1.0 mm
Standard Deviation 6.50
|
|
Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 84 (n=7)
|
2.9 mm
Standard Deviation 13.09
|
|
Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Follow Up (n=33)
|
4.4 mm
Standard Deviation 8.65
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The participant or parent/guardian, as appropriate, provides a rating of the participant's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end represents 'very poor' (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Baseline (n=41)
|
4.0 mm
Standard Deviation 5.72
|
|
Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 12 (n=41)
|
-0.2 mm
Standard Deviation 3.31
|
|
Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 24 (n=41)
|
-1.5 mm
Standard Deviation 4.38
|
|
Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 36 (n=35)
|
-2.2 mm
Standard Deviation 4.34
|
|
Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 48 (n=22)
|
-2.2 mm
Standard Deviation 4.89
|
|
Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 60 (n=17)
|
-1.2 mm
Standard Deviation 2.08
|
|
Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 72 (n=10)
|
-0.9 mm
Standard Deviation 1.60
|
|
Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Follow Up (n=33)
|
3.2 mm
Standard Deviation 7.39
|
|
Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 84 (n=7)
|
-0.9 mm
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Baseline (n=41)
|
5.0 millimeters per hour (mm/hour)
Standard Deviation 4.08
|
|
Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 12 (n=41)
|
-0.95 millimeters per hour (mm/hour)
Standard Deviation 3.83
|
|
Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 24 (n=41)
|
-0.9 millimeters per hour (mm/hour)
Standard Deviation 5.01
|
|
Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 36 (n=35)
|
-1.2 millimeters per hour (mm/hour)
Standard Deviation 5.26
|
|
Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 48 (n=22)
|
-0.9 millimeters per hour (mm/hour)
Standard Deviation 3.30
|
|
Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 60 (n=17)
|
-0.35 millimeters per hour (mm/hour)
Standard Deviation 5.22
|
|
Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 72 (n=10)
|
0.5 millimeters per hour (mm/hour)
Standard Deviation 6.88
|
|
Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 84 (n=7)
|
3.3 millimeters per hour (mm/hour)
Standard Deviation 14.68
|
|
Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Follow Up (n=33)
|
5.9 millimeters per hour (mm/hour)
Standard Deviation 8.07
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Baseline (n=41)
|
0.1 units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 12 (n=41)
|
-0.0 units on a scale
Standard Deviation 0.06
|
|
Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 24 (n=41)
|
0.0 units on a scale
Standard Deviation 0.09
|
|
Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 36 (n=35)
|
-0.0 units on a scale
Standard Deviation 0.09
|
|
Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 48 (n=22)
|
-0.1 units on a scale
Standard Deviation 0.15
|
|
Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 60 (n=17)
|
0.0 units on a scale
Standard Deviation 0.08
|
|
Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 72 (n=10)
|
-0.1 units on a scale
Standard Deviation 0.09
|
|
Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Week 84 (n=7)
|
-0.1 units on a scale
Standard Deviation 0.26
|
|
Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
Change From Baseline at Follow Up (n=33)
|
0.1 units on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population
The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A minimally important improvement was defined as at least a 0.13 improvement in CHAQ-DI score from baseline.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Week 12
|
2.4 percentage of participants
Interval 0.1 to 12.9
|
|
Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Week 24
|
2.4 percentage of participants
Interval 0.1 to 12.9
|
|
Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Week 36
|
5.7 percentage of participants
Interval 0.7 to 19.2
|
|
Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Week 48
|
18.2 percentage of participants
Interval 5.2 to 40.3
|
|
Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Week 72
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
|
Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Week 84
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
|
Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Follow Up
|
15.2 percentage of participants
Interval 5.1 to 31.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Activity component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 72 (n=10)
|
-0.1 units on a scale
Standard Deviation 0.57
|
|
Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Baseline (n=40)
|
0.2 units on a scale
Standard Deviation 0.41
|
|
Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 12 (n=39)
|
0.0 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 24 (n=39)
|
0.0 units on a scale
Standard Deviation 0.28
|
|
Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 36 (n=34)
|
0.0 units on a scale
Standard Deviation 0.35
|
|
Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 48 (n=22)
|
-0.1 units on a scale
Standard Deviation 0.35
|
|
Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 60 (n=17)
|
-0.1 units on a scale
Standard Deviation 0.43
|
|
Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 84 (n=7)
|
-0.1 units on a scale
Standard Deviation 0.38
|
|
Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Follow Up (n=33)
|
-0.1 units on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Arising component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Baseline (n=41)
|
0.0 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 12 (n=40)
|
0.0 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 24 (n=40)
|
0.0 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 36 (n=34)
|
-0.0 units on a scale
Standard Deviation 0.17
|
|
Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 48 (n=22)
|
-0.0 units on a scale
Standard Deviation 0.21
|
|
Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 60 (n=17)
|
-0.1 units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 72 (n=10)
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 84 (n=7)
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Follow Up (n=33)
|
0.0 units on a scale
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Dressing and Grooming component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Baseline (n=41)
|
0.1 units on a scale
Standard Deviation 0.42
|
|
Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 12 (n=40)
|
0.0 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 24 (n=40)
|
0.1 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 36 (n=34)
|
0.1 units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 48 (n=22)
|
0.0 units on a scale
Standard Deviation 0.31
|
|
Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 60 (n=17)
|
0.0 units on a scale
Standard Deviation 0.35
|
|
Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 72 (n=10)
|
-0.2 units on a scale
Standard Deviation 0.63
|
|
Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 84 (n=7)
|
-0.3 units on a scale
Standard Deviation 0.76
|
|
Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Follow Up (n=33)
|
-0.1 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Eating component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Baseline (n=41)
|
0.1 units on a scale
Standard Deviation 0.33
|
|
Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 12 (n=40)
|
0.0 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 24 (n=40)
|
0.0 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 36 (n=34)
|
0.0 units on a scale
Standard Deviation 0.25
|
|
Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 48 (n=22)
|
-0.1 units on a scale
Standard Deviation 0.29
|
|
Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 60 (n=17)
|
0.1 units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 72 (n=10)
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 84 (n=7)
|
-0.1 units on a scale
Standard Deviation 0.38
|
|
Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Follow Up (n=33)
|
-0.0 units on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Grip component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 12 (n=40)
|
-0.1 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 24 (n=40)
|
-0.0 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 36 (n=34)
|
-0.1 units on a scale
Standard Deviation 0.29
|
|
Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 48 (n=22)
|
-0.1 units on a scale
Standard Deviation 0.29
|
|
Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 60 (n=17)
|
0.1 units on a scale
Standard Deviation 0.43
|
|
Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 72 (n=10)
|
0.0 units on a scale
Standard Deviation 0.47
|
|
Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 84 (n=7)
|
-0.1 units on a scale
Standard Deviation 0.38
|
|
Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Follow Up (n=33)
|
-0.1 units on a scale
Standard Deviation 0.29
|
|
Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Baseline (n=41)
|
0.2 units on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Hygiene component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Baseline (n=41)
|
0.2 units on a scale
Standard Deviation 0.44
|
|
Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 12 (n=40)
|
-0.0 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 24 (n=40)
|
0.0 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 36 (n=34)
|
-0.1 units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 48 (n=22)
|
-0.1 units on a scale
Standard Deviation 0.35
|
|
Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 60 (n=17)
|
-0.1 units on a scale
Standard Deviation 0.43
|
|
Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 72 (n=10)
|
-0.1 units on a scale
Standard Deviation 0.32
|
|
Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 84 (n=7)
|
-0.4 units on a scale
Standard Deviation 0.79
|
|
Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Follow Up (n=33)
|
-0.2 units on a scale
Standard Deviation 46
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Reach component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Baseline (n=41)
|
0.2 units on a scale
Standard Deviation 0.42
|
|
Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 12 (n=40)
|
-0.0 units on a scale
Standard Deviation 0.28
|
|
Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 24 (n=40)
|
-0.1 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 36 (n=34)
|
-0.0 units on a scale
Standard Deviation 0.30
|
|
Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 48 (n=22)
|
-0.1 units on a scale
Standard Deviation 0.29
|
|
Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 60 (n=17)
|
0.1 units on a scale
Standard Deviation 0.43
|
|
Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 72 (n=10)
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 84 (n=7)
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Follow Up (n=33)
|
-0.1 units on a scale
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Walking component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Baseline (n=41)
|
0.0 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 12 (n=40)
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 24 (n=40)
|
0.1 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 36 (n=34)
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 48 (n=22)
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 60 (n=17)
|
0.1 units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 72 (n=10)
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Week 84 (n=7)
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
Change From Baseline at Follow Up (n=33)
|
0.0 units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, End of follow up (up to 101 weeks)Population: Safety population. Here, 'n' signifies the number of participants with available data for specified category.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
|
|---|---|
|
Absolute C-Reactive Protein Levels
Baseline (n=40)
|
0.9468 milligrams per Liter
Standard Deviation 4.11395
|
|
Absolute C-Reactive Protein Levels
Week 4 (n=39)
|
0.9755 milligrams per Liter
Standard Deviation 1.71814
|
|
Absolute C-Reactive Protein Levels
Week 8 (n=41)
|
1.8995 milligrams per Liter
Standard Deviation 6.17464
|
|
Absolute C-Reactive Protein Levels
Week 12 (n=41)
|
1.7157 milligrams per Liter
Standard Deviation 3.07714
|
|
Absolute C-Reactive Protein Levels
Week 16 (n=41)
|
2.4115 milligrams per Liter
Standard Deviation 8.71986
|
|
Absolute C-Reactive Protein Levels
Week 20 (n=39)
|
0.9706 milligrams per Liter
Standard Deviation 2.67299
|
|
Absolute C-Reactive Protein Levels
Week 24 (n=41)
|
1.4893 milligrams per Liter
Standard Deviation 3.24038
|
|
Absolute C-Reactive Protein Levels
Week 28 (n=40)
|
2.2320 milligrams per Liter
Standard Deviation 5.51994
|
|
Absolute C-Reactive Protein Levels
Week 32 (n=39)
|
2.1713 milligrams per Liter
Standard Deviation 7.09086
|
|
Absolute C-Reactive Protein Levels
Week 36 (n=35)
|
1.6507 milligrams per Liter
Standard Deviation 4.81621
|
|
Absolute C-Reactive Protein Levels
Week 40 (n=31)
|
1.2562 milligrams per Liter
Standard Deviation 2.49440
|
|
Absolute C-Reactive Protein Levels
Week 44 (n=26)
|
1.1710 milligrams per Liter
Standard Deviation 1.96013
|
|
Absolute C-Reactive Protein Levels
Week 48 (n=22)
|
1.2382 milligrams per Liter
Standard Deviation 1.98754
|
|
Absolute C-Reactive Protein Levels
Week 52 (n=22)
|
1.2019 milligrams per Liter
Standard Deviation 1.71587
|
|
Absolute C-Reactive Protein Levels
Week 56 (n=18)
|
3.9651 milligrams per Liter
Standard Deviation 12.83795
|
|
Absolute C-Reactive Protein Levels
Week 60 (n=17)
|
2.6449 milligrams per Liter
Standard Deviation 8.93648
|
|
Absolute C-Reactive Protein Levels
Week 64 (n=15)
|
0.6341 milligrams per Liter
Standard Deviation 1.40213
|
|
Absolute C-Reactive Protein Levels
Week 68 (n=11)
|
0.5210 milligrams per Liter
Standard Deviation 1.49015
|
|
Absolute C-Reactive Protein Levels
Week 72 (n=10)
|
1.5263 milligrams per Liter
Standard Deviation 1.97617
|
|
Absolute C-Reactive Protein Levels
Week 76 (n=8)
|
2.0304 milligrams per Liter
Standard Deviation 2.49171
|
|
Absolute C-Reactive Protein Levels
Week 80 (n=7)
|
1.4975 milligrams per Liter
Standard Deviation 2.39680
|
|
Absolute C-Reactive Protein Levels
Week 84 (n=7)
|
11.4459 milligrams per Liter
Standard Deviation 25.92600
|
|
Absolute C-Reactive Protein Levels
Week 88 (n=3)
|
0.0704 milligrams per Liter
Standard Deviation 0.06935
|
|
Absolute C-Reactive Protein Levels
Follow up (n=32)
|
2.3169 milligrams per Liter
Standard Deviation 3.24139
|
Adverse Events
Tocilizumab
Serious adverse events
| Measure |
Tocilizumab
n=41 participants at risk
Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
|
|---|---|
|
Injury, poisoning and procedural complications
Multiple injuries
|
2.4%
1/41 • Baseline to 12 weeks after last actual study medication (up to 101 weeks)
Analysis was performed on safety population.
|
|
Investigations
Neutrophil count decreased
|
2.4%
1/41 • Baseline to 12 weeks after last actual study medication (up to 101 weeks)
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Proteinuria
|
2.4%
1/41 • Baseline to 12 weeks after last actual study medication (up to 101 weeks)
Analysis was performed on safety population.
|
Other adverse events
| Measure |
Tocilizumab
n=41 participants at risk
Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
7.3%
3/41 • Baseline to 12 weeks after last actual study medication (up to 101 weeks)
Analysis was performed on safety population.
|
|
Infections and infestations
Pharyngitis
|
14.6%
6/41 • Baseline to 12 weeks after last actual study medication (up to 101 weeks)
Analysis was performed on safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.2%
5/41 • Baseline to 12 weeks after last actual study medication (up to 101 weeks)
Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis
|
9.8%
4/41 • Baseline to 12 weeks after last actual study medication (up to 101 weeks)
Analysis was performed on safety population.
|
Additional Information
Medical Communications
Hoffmann-LaRoche or Genentech, Inc
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