Trial Outcomes & Findings for A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA) (NCT NCT01904279)
NCT ID: NCT01904279
Last Updated: 2017-06-14
Results Overview
Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
Results posted on
2017-06-14
Participant Flow
A total of 52 participants were enrolled in the study. Study included a 21-day screening period.
Participant milestones
| Measure |
TCZ SC 162 mg Q3W
Participants with body weight less than (\<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks.
|
TCZ SC 162 mg Q2W
Participants with body weight greater than or equal to (\>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
TCZ SC 162 mg Q3W
Participants with body weight less than (\<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks.
|
TCZ SC 162 mg Q2W
Participants with body weight greater than or equal to (\>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)
Baseline characteristics by cohort
| Measure |
TCZ SC 162 mg Q3W
n=27 Participants
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=25 Participants
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.5 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
9.6 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)Population: Pharmacokinetic population included all enrolled participants who were adherent to the protocol.
Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
Outcome measures
| Measure |
TCZ SC 162 mg Q3W
n=27 Participants
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=25 Participants
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
|---|---|---|
|
Minimum Serum Concentration (Cmin) of TCZ at Steady State
|
13.35 Micrograms/milliliter (mcg/mL)
Interval 0.21 to 52.25
|
12.71 Micrograms/milliliter (mcg/mL)
Interval 0.19 to 23.75
|
PRIMARY outcome
Timeframe: Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)Population: Pharmacokinetic population.
Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.
Outcome measures
| Measure |
TCZ SC 162 mg Q3W
n=27 Participants
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=25 Participants
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
|---|---|---|
|
Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment
|
2998 mcg*day/mL
Interval 1465.0 to 7708.0
|
1933 mcg*day/mL
Interval 324.0 to 3098.0
|
PRIMARY outcome
Timeframe: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)Population: Pharmacokinetic population
Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
Outcome measures
| Measure |
TCZ SC 162 mg Q3W
n=27 Participants
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=25 Participants
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of TCZ at Steady State
|
62.44 mcg/mL
Interval 39.37 to 121.13
|
29.74 mcg/mL
Interval 7.56 to 50.3
|
SECONDARY outcome
Timeframe: Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52Population: Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.
IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.
Outcome measures
| Measure |
TCZ SC 162 mg Q3W
n=18 Participants
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=23 Participants
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 14
|
—
|
11.958 picograms/milliliter (pg/mL)
Standard Deviation 16.665
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 15
|
-21.565 picograms/milliliter (pg/mL)
Standard Deviation 312.758
|
122.88 picograms/milliliter (pg/mL)
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Day 84.25
|
32.644 picograms/milliliter (pg/mL)
Standard Deviation 65.094
|
14.66 picograms/milliliter (pg/mL)
Standard Deviation 24.026
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Day 84.5
|
-46.575 picograms/milliliter (pg/mL)
Standard Deviation 318.217
|
24.478 picograms/milliliter (pg/mL)
Standard Deviation 31.747
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Day 85
|
—
|
27.934 picograms/milliliter (pg/mL)
Standard Deviation 53.23
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Day 86
|
-53.35 picograms/milliliter (pg/mL)
Standard Deviation 285.831
|
36.06 picograms/milliliter (pg/mL)
Standard Deviation 82.547
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Day 88
|
-42.836 picograms/milliliter (pg/mL)
Standard Deviation 280.041
|
19.397 picograms/milliliter (pg/mL)
Standard Deviation 22.712
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Day 90
|
-51.899 picograms/milliliter (pg/mL)
Standard Deviation 299.59
|
20.642 picograms/milliliter (pg/mL)
Standard Deviation 20.247
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Baseline
|
77.569 picograms/milliliter (pg/mL)
Standard Deviation 278.376
|
10.567 picograms/milliliter (pg/mL)
Standard Deviation 11.24
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Day 0.25
|
-15.309 picograms/milliliter (pg/mL)
Standard Deviation 108.157
|
4.575 picograms/milliliter (pg/mL)
Standard Deviation 7.555
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Day 0.5
|
-16.181 picograms/milliliter (pg/mL)
Standard Deviation 116.587
|
11.932 picograms/milliliter (pg/mL)
Standard Deviation 13.33
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Day 2
|
17.998 picograms/milliliter (pg/mL)
Standard Deviation 157.295
|
23.223 picograms/milliliter (pg/mL)
Standard Deviation 23.935
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Day 5
|
17.265 picograms/milliliter (pg/mL)
Standard Deviation 186.212
|
35.263 picograms/milliliter (pg/mL)
Standard Deviation 64.907
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 2
|
—
|
21.751 picograms/milliliter (pg/mL)
Standard Deviation 49.964
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 3
|
-12.801 picograms/milliliter (pg/mL)
Standard Deviation 198.038
|
—
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 4
|
—
|
15.944 picograms/milliliter (pg/mL)
Standard Deviation 26.322
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 6
|
-0.412 picograms/milliliter (pg/mL)
Standard Deviation 271.409
|
17.841 picograms/milliliter (pg/mL)
Standard Deviation 34.515
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 12
|
-45.569 picograms/milliliter (pg/mL)
Standard Deviation 294.169
|
17.236 picograms/milliliter (pg/mL)
Standard Deviation 28.727
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 27
|
-16.408 picograms/milliliter (pg/mL)
Standard Deviation 293.156
|
—
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 28
|
—
|
14.206 picograms/milliliter (pg/mL)
Standard Deviation 20.762
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 36
|
-38.921 picograms/milliliter (pg/mL)
Standard Deviation 303.851
|
13.273 picograms/milliliter (pg/mL)
Standard Deviation 24.814
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 44
|
—
|
14.765 picograms/milliliter (pg/mL)
Standard Deviation 18.458
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Week 52
|
-44.611 picograms/milliliter (pg/mL)
Standard Deviation 289.698
|
10.401 picograms/milliliter (pg/mL)
Standard Deviation 18.455
|
SECONDARY outcome
Timeframe: Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52Population: Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.
Outcome measures
| Measure |
TCZ SC 162 mg Q3W
n=20 Participants
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=23 Participants
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Baseline
|
140.4 nanograms per milliliter (ng/mL)
Standard Deviation 225.72
|
206.7 nanograms per milliliter (ng/mL)
Standard Deviation 241.69
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 0.25
|
-4.04 nanograms per milliliter (ng/mL)
Standard Deviation 41.14
|
1.78 nanograms per milliliter (ng/mL)
Standard Deviation 29.68
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 0.5
|
-1.45 nanograms per milliliter (ng/mL)
Standard Deviation 53.39
|
4.58 nanograms per milliliter (ng/mL)
Standard Deviation 51.71
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 2
|
89.72 nanograms per milliliter (ng/mL)
Standard Deviation 75.29
|
68.90 nanograms per milliliter (ng/mL)
Standard Deviation 66.75
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 4
|
323.4 nanograms per milliliter (ng/mL)
Standard Deviation NA
The data was not available as single participant was evaluated.
|
—
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 5
|
194.46 nanograms per milliliter (ng/mL)
Standard Deviation 143.28
|
124.65 nanograms per milliliter (ng/mL)
Standard Deviation 100.58
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 2
|
—
|
193.25 nanograms per milliliter (ng/mL)
Standard Deviation 158.69
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 3
|
418.54 nanograms per milliliter (ng/mL)
Standard Deviation 237.02
|
—
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 4
|
—
|
239.86 nanograms per milliliter (ng/mL)
Standard Deviation 194.47
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 6
|
407.36 nanograms per milliliter (ng/mL)
Standard Deviation 344.44
|
233.82 nanograms per milliliter (ng/mL)
Standard Deviation 234.92
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 12
|
464.77 nanograms per milliliter (ng/mL)
Standard Deviation 317.77
|
286.06 nanograms per milliliter (ng/mL)
Standard Deviation 260.33
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 84.25
|
461.85 nanograms per milliliter (ng/mL)
Standard Deviation 280.99
|
245.05 nanograms per milliliter (ng/mL)
Standard Deviation 253.45
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 84.5
|
482.55 nanograms per milliliter (ng/mL)
Standard Deviation 299.43
|
274.85 nanograms per milliliter (ng/mL)
Standard Deviation 230.86
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 85
|
—
|
268.72 nanograms per milliliter (ng/mL)
Standard Deviation 254.46
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 86
|
461.19 nanograms per milliliter (ng/mL)
Standard Deviation 345.97
|
244.53 nanograms per milliliter (ng/mL)
Standard Deviation 257.08
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 88
|
514.89 nanograms per milliliter (ng/mL)
Standard Deviation 303.29
|
256.47 nanograms per milliliter (ng/mL)
Standard Deviation 234.7
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Day 90
|
494.05 nanograms per milliliter (ng/mL)
Standard Deviation 276.35
|
292.29 nanograms per milliliter (ng/mL)
Standard Deviation 229.2
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 14
|
—
|
272.93 nanograms per milliliter (ng/mL)
Standard Deviation 241.9
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 15
|
497.21 nanograms per milliliter (ng/mL)
Standard Deviation 295.29
|
200 nanograms per milliliter (ng/mL)
Standard Deviation NA
The data was not available as single participant was evaluated.
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 27
|
532.81 nanograms per milliliter (ng/mL)
Standard Deviation 270.07
|
—
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 28
|
—
|
295.28 nanograms per milliliter (ng/mL)
Standard Deviation 286.78
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 36
|
416.02 nanograms per milliliter (ng/mL)
Standard Deviation 305.07
|
269.32 nanograms per milliliter (ng/mL)
Standard Deviation 276.03
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 44
|
—
|
243.93 nanograms per milliliter (ng/mL)
Standard Deviation 299.72
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Week 52
|
470.6 nanograms per milliliter (ng/mL)
Standard Deviation 263.38
|
209.51 nanograms per milliliter (ng/mL)
Standard Deviation 318.38
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52Population: Safety population. Number Analyzed represents participants evaluable for the specified category.
Outcome measures
| Measure |
TCZ SC 162 mg Q3W
n=27 Participants
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=25 Participants
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
|---|---|---|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 27
|
-3.122 mg/L
Standard Deviation 5.279
|
—
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Baseline
|
3.391 mg/L
Standard Deviation 5.27
|
3.356 mg/L
Standard Deviation 6.908
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 4
|
—
|
-2.187 mg/L
Standard Deviation 5.270
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 6
|
-3 mg/L
Standard Deviation 5.21
|
-2.368 mg/L
Standard Deviation 5.735
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 9
|
-3.069 mg/L
Standard Deviation 5.346
|
—
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 12
|
-3.16 mg/L
Standard Deviation 5.285
|
-1.783 mg/L
Standard Deviation 4.559
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 18
|
-3.213 mg/L
Standard Deviation 5.377
|
—
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 20
|
—
|
-1.336 mg/L
Standard Deviation 6.158
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 28
|
—
|
-2.467 mg/L
Standard Deviation 6.455
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 36
|
-3.254 mg/L
Standard Deviation 5.492
|
-2.209 mg/L
Standard Deviation 5.316
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 44
|
—
|
-2.039 mg/L
Standard Deviation 5.47
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 45
|
-3.153 mg/L
Standard Deviation 5.385
|
—
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 51
|
-3.344 mg/L
Standard Deviation 5.453
|
—
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Week 52
|
—
|
-2.225 mg/L
Standard Deviation 5.285
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52Population: Safety population. Number Analyzed represents participants evaluable for the specified category.
The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
TCZ SC 162 mg Q3W
n=27 Participants
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=25 Participants
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Baseline
|
15.9 millimeters per hour (mm/h)
Standard Deviation 14.2
|
13 millimeters per hour (mm/h)
Standard Deviation 13.1
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 4
|
—
|
-7.0 millimeters per hour (mm/h)
Standard Deviation 9
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 6
|
-10.6 millimeters per hour (mm/h)
Standard Deviation 12.8
|
-7.2 millimeters per hour (mm/h)
Standard Deviation 10.5
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 9
|
-9.9 millimeters per hour (mm/h)
Standard Deviation 10.9
|
—
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 12
|
-9.8 millimeters per hour (mm/h)
Standard Deviation 12.4
|
-6.8 millimeters per hour (mm/h)
Standard Deviation 13
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 18
|
-11.8 millimeters per hour (mm/h)
Standard Deviation 12.3
|
—
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 20
|
—
|
-7.9 millimeters per hour (mm/h)
Standard Deviation 11.2
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 27
|
-11.9 millimeters per hour (mm/h)
Standard Deviation 12.2
|
—
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 28
|
—
|
-8 millimeters per hour (mm/h)
Standard Deviation 14.2
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 36
|
-11.8 millimeters per hour (mm/h)
Standard Deviation 12.8
|
-8 millimeters per hour (mm/h)
Standard Deviation 13.1
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 44
|
—
|
-10.2 millimeters per hour (mm/h)
Standard Deviation 13
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 45
|
-12 millimeters per hour (mm/h)
Standard Deviation 12.2
|
—
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 51
|
-12.2 millimeters per hour (mm/h)
Standard Deviation 13
|
—
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 52
|
—
|
-8.5 millimeters per hour (mm/h)
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Safety population.
Outcome measures
| Measure |
TCZ SC 162 mg Q3W
n=27 Participants
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=25 Participants
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
|---|---|---|
|
Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential
|
3.7 percentage of participants
|
8.0 percentage of participants
|
Adverse Events
TCZ SC 162 mg Q3W
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
TCZ SC 162 mg Q2W
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TCZ SC 162 mg Q3W
n=27 participants at risk
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=25 participants at risk
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
4.0%
1/25 • Baseline up to Week 56
Safety population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
4.0%
1/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Croup infectious
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
0.00%
0/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Varicella
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
0.00%
0/25 • Baseline up to Week 56
Safety population
|
Other adverse events
| Measure |
TCZ SC 162 mg Q3W
n=27 participants at risk
Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
|
TCZ SC 162 mg Q2W
n=25 participants at risk
Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
3/27 • Baseline up to Week 56
Safety population
|
4.0%
1/25 • Baseline up to Week 56
Safety population
|
|
Ear and labyrinth disorders
Ear Pain
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
4.0%
1/25 • Baseline up to Week 56
Safety population
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
3/27 • Baseline up to Week 56
Safety population
|
12.0%
3/25 • Baseline up to Week 56
Safety population
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
12.0%
3/25 • Baseline up to Week 56
Safety population
|
|
Gastrointestinal disorders
Constipation
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
4.0%
1/25 • Baseline up to Week 56
Safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
16.0%
4/25 • Baseline up to Week 56
Safety population
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
20.0%
5/25 • Baseline up to Week 56
Safety population
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
4/27 • Baseline up to Week 56
Safety population
|
20.0%
5/25 • Baseline up to Week 56
Safety population
|
|
General disorders
Fatigue
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
General disorders
Injection Site Erythema
|
14.8%
4/27 • Baseline up to Week 56
Safety population
|
24.0%
6/25 • Baseline up to Week 56
Safety population
|
|
General disorders
Injection Site Haematoma
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
General disorders
Injection Site Pain
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
General disorders
Injection Site Swelling
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
General disorders
Pyrexia
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
16.0%
4/25 • Baseline up to Week 56
Safety population
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Bronchitis
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
4.0%
1/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Ear Infection
|
14.8%
4/27 • Baseline up to Week 56
Safety population
|
0.00%
0/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Gastroenteritis
|
14.8%
4/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Impetigo
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
0.00%
0/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Influenza
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
0.00%
0/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Nasophryngitis
|
40.7%
11/27 • Baseline up to Week 56
Safety population
|
28.0%
7/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Otitis Media
|
11.1%
3/27 • Baseline up to Week 56
Safety population
|
0.00%
0/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Paronychia
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Rhinitis
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
12.0%
3/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
16.0%
4/25 • Baseline up to Week 56
Safety population
|
|
Infections and infestations
Viral Infection
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
0.00%
0/25 • Baseline up to Week 56
Safety population
|
|
Investigations
Alanine Aminotransferase Increased
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.5%
5/27 • Baseline up to Week 56
Safety population
|
16.0%
4/25 • Baseline up to Week 56
Safety population
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
3/27 • Baseline up to Week 56
Safety population
|
4.0%
1/25 • Baseline up to Week 56
Safety population
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
Musculoskeletal and connective tissue disorders
Juvenile Idiopathic Arthritis
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
12.0%
3/25 • Baseline up to Week 56
Safety population
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
4.0%
1/25 • Baseline up to Week 56
Safety population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
16.0%
4/25 • Baseline up to Week 56
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
24.0%
6/25 • Baseline up to Week 56
Safety population
|
|
Psychiatric disorders
Insomnia
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.0%
10/27 • Baseline up to Week 56
Safety population
|
12.0%
3/25 • Baseline up to Week 56
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
12.0%
3/25 • Baseline up to Week 56
Safety population
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
0.00%
0/25 • Baseline up to Week 56
Safety population
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.4%
2/27 • Baseline up to Week 56
Safety population
|
12.0%
3/25 • Baseline up to Week 56
Safety population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
|
Vascular disorders
Haematoma
|
3.7%
1/27 • Baseline up to Week 56
Safety population
|
8.0%
2/25 • Baseline up to Week 56
Safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER