A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)

A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01904279

Acronym

JIGSAW 117

Enrollment

Registered

2013-07-22

Start date

2013-07-31

Completion date

2016-05-31

Last updated

2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Idiopathic Arthritis

Brief summary

This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.

Interventions

DRUGTocilizumab

Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Ages 1 year (12 years for participants in Russia) up to and including 17 years at screening * Diagnosis of pJIA according to International League of Associations for Rheumatology classification * Rheumatoid factor (RF)-positive pJIA * RF-negative pJIA * Extended oligoarticular JIA with a polyarticular course * History of inadequate clinical response (in the opinion of the treating physician) to or inability to tolerate methotrexate (MTX) * Participants currently receiving TCZ by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV TCZ and should have their first dose of SC TCZ administered on the date that their next IV TCZ infusion would be due. Participants participating in the study may be either naive to TCZ therapy or may be switching from IV to SC. The total number of participants switching from IV TCZ must account for no more than 50 percent (%) of the total participant number. To account for the baseline TCZ concentrations in these participants, information on the last 4 IV TCZ infusions prior to baseline will be collected * Concurrent treatment with disease-modifying antirheumatic drugs (DMARDs) (including MTX), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids are permitted at the discretion of the investigator * Females of childbearing potential and non-sterile males with female partner of childbearing potential must agree to use effective contraception as defined by protocol

Exclusion criteria

* Prior discontinuation of IV TCZ because of inadequate clinical response or safety events (including hypersensitivity) * Participants with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ * pJIA that is well controlled by any treatment agent other than TCZ (Juvenile Arthritis Disease Activity Score 71 \[JADAS-71\] less than or equal to (\< / =) 3.8) * Participants who are wheelchair-bound or bedridden * Any other auto-immune, rheumatic disease, or overlapping syndrome other than the permitted pcJIA subsets * Lack of recovery from recent surgery or an interval of \<6 weeks since surgery at the time of the screening visit * Females who are pregnant, lactating, or intending to become pregnant during study conduct * Any significant concurrent medical or surgical condition that would jeopardize the participant's safety or ability to complete the study * Known human immunodeficiency virus (HIV) infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system * History of alcohol, drug, or chemical abuse within 6 months of screening * Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit * History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening visit * Positive purified protein derivative (PPD) at screen, unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug and chest radiograph is negative for active TB within 6 months of screening visit according to local practice * History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein-Barr virus within 2 months of the screening visit * Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis * History of concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions * History of or current cancer or lymphoma * Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin * Active uveitis at screening * Inadequate hematologic, renal or liver function * Prior stem cell transplant at any time

Design outcomes

Primary

Measure	Time frame	Description
Minimum Serum Concentration (Cmin) of TCZ at Steady State	Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)	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.
Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment	Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)	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.
Maximum Serum Concentration (Cmax) of TCZ at Steady State	Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)	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.

Secondary

Measure	Time frame	Description
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52	The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.
Change From Baseline in Serum Interleukin-6 (IL-6) Levels	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, 52	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.
Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential	Baseline up to Week 52	—
Change From Baseline in Soluble IL-6 Receptor Levels	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, 52	—
Change From Baseline in C-Reactive Protein (CRP) Levels	Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52	—

Countries

Argentina, Australia, Brazil, Canada, France, Germany, Italy, Mexico, Russia, Spain, United Kingdom, United States

Participant flow

Recruitment details

A total of 52 participants were enrolled in the study. Study included a 21-day screening period.

Participants by arm

Arm	Count
TCZ SC 162 mg Q3W Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.	27
TCZ SC 162 mg Q2W Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.	25
Total	52

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lack of Efficacy	2	3
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	TCZ SC 162 mg Q3W	TCZ SC 162 mg Q2W	Total
Age, Continuous	5.5 years STANDARD_DEVIATION 2.1	13.9 years STANDARD_DEVIATION 2.7	9.6 years STANDARD_DEVIATION 4.9
Sex: Female, Male Female	18 Participants	18 Participants	36 Participants
Sex: Female, Male Male	9 Participants	7 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	23 / 27	22 / 25
serious Total, serious adverse events	1 / 27	2 / 25

Outcome results

Primary

Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment

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.

Time frame: Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)

Population: Pharmacokinetic population.

Arm	Measure	Value (MEAN)
TCZ SC 162 mg Q3W	Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment	2998 mcg*day/mL
TCZ SC 162 mg Q2W	Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment	1933 mcg*day/mL

Primary

Maximum Serum Concentration (Cmax) of TCZ at Steady State

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.

Time frame: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)

Population: Pharmacokinetic population

Arm	Measure	Value (MEDIAN)
TCZ SC 162 mg Q3W	Maximum Serum Concentration (Cmax) of TCZ at Steady State	62.44 mcg/mL
TCZ SC 162 mg Q2W	Maximum Serum Concentration (Cmax) of TCZ at Steady State	29.74 mcg/mL

Primary

Minimum Serum Concentration (Cmin) of TCZ at Steady State

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.

Time frame: 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.

Arm	Measure	Value (MEDIAN)
TCZ SC 162 mg Q3W	Minimum Serum Concentration (Cmin) of TCZ at Steady State	13.35 Micrograms/milliliter (mcg/mL)
TCZ SC 162 mg Q2W	Minimum Serum Concentration (Cmin) of TCZ at Steady State	12.71 Micrograms/milliliter (mcg/mL)

Secondary

Change From Baseline in C-Reactive Protein (CRP) Levels

Time frame: Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52

Population: Safety population. Number Analyzed represents participants evaluable for the specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
TCZ SC 162 mg Q3W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 51	-3.344 mg/L	Standard Deviation 5.453
TCZ SC 162 mg Q3W	Change From Baseline in C-Reactive Protein (CRP) Levels	Baseline	3.391 mg/L	Standard Deviation 5.27
TCZ SC 162 mg Q3W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 6	-3 mg/L	Standard Deviation 5.21
TCZ SC 162 mg Q3W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 9	-3.069 mg/L	Standard Deviation 5.346
TCZ SC 162 mg Q3W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 12	-3.16 mg/L	Standard Deviation 5.285
TCZ SC 162 mg Q3W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 18	-3.213 mg/L	Standard Deviation 5.377
TCZ SC 162 mg Q3W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 27	-3.122 mg/L	Standard Deviation 5.279
TCZ SC 162 mg Q3W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 36	-3.254 mg/L	Standard Deviation 5.492
TCZ SC 162 mg Q3W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 45	-3.153 mg/L	Standard Deviation 5.385
TCZ SC 162 mg Q2W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 36	-2.209 mg/L	Standard Deviation 5.316
TCZ SC 162 mg Q2W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 20	-1.336 mg/L	Standard Deviation 6.158
TCZ SC 162 mg Q2W	Change From Baseline in C-Reactive Protein (CRP) Levels	Baseline	3.356 mg/L	Standard Deviation 6.908
TCZ SC 162 mg Q2W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 4	-2.187 mg/L	Standard Deviation 5.27
TCZ SC 162 mg Q2W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 44	-2.039 mg/L	Standard Deviation 5.47
TCZ SC 162 mg Q2W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 6	-2.368 mg/L	Standard Deviation 5.735
TCZ SC 162 mg Q2W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 28	-2.467 mg/L	Standard Deviation 6.455
TCZ SC 162 mg Q2W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 52	-2.225 mg/L	Standard Deviation 5.285
TCZ SC 162 mg Q2W	Change From Baseline in C-Reactive Protein (CRP) Levels	Week 12	-1.783 mg/L	Standard Deviation 4.559

Secondary

Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.

Time frame: Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52

Population: Safety population. Number Analyzed represents participants evaluable for the specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
TCZ SC 162 mg Q3W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 9	-9.9 millimeters per hour (mm/h)	Standard Deviation 10.9
TCZ SC 162 mg Q3W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 27	-11.9 millimeters per hour (mm/h)	Standard Deviation 12.2
TCZ SC 162 mg Q3W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 12	-9.8 millimeters per hour (mm/h)	Standard Deviation 12.4
TCZ SC 162 mg Q3W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 36	-11.8 millimeters per hour (mm/h)	Standard Deviation 12.8
TCZ SC 162 mg Q3W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 6	-10.6 millimeters per hour (mm/h)	Standard Deviation 12.8
TCZ SC 162 mg Q3W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 18	-11.8 millimeters per hour (mm/h)	Standard Deviation 12.3
TCZ SC 162 mg Q3W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 45	-12 millimeters per hour (mm/h)	Standard Deviation 12.2
TCZ SC 162 mg Q3W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 51	-12.2 millimeters per hour (mm/h)	Standard Deviation 13
TCZ SC 162 mg Q3W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Baseline	15.9 millimeters per hour (mm/h)	Standard Deviation 14.2
TCZ SC 162 mg Q2W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 52	-8.5 millimeters per hour (mm/h)	Standard Deviation 13.2
TCZ SC 162 mg Q2W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Baseline	13 millimeters per hour (mm/h)	Standard Deviation 13.1
TCZ SC 162 mg Q2W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 4	-7.0 millimeters per hour (mm/h)	Standard Deviation 9
TCZ SC 162 mg Q2W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 6	-7.2 millimeters per hour (mm/h)	Standard Deviation 10.5
TCZ SC 162 mg Q2W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 12	-6.8 millimeters per hour (mm/h)	Standard Deviation 13
TCZ SC 162 mg Q2W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 20	-7.9 millimeters per hour (mm/h)	Standard Deviation 11.2
TCZ SC 162 mg Q2W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 28	-8 millimeters per hour (mm/h)	Standard Deviation 14.2
TCZ SC 162 mg Q2W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 36	-8 millimeters per hour (mm/h)	Standard Deviation 13.1
TCZ SC 162 mg Q2W	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 44	-10.2 millimeters per hour (mm/h)	Standard Deviation 13

Secondary

Change From Baseline in Serum Interleukin-6 (IL-6) Levels

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.

Time frame: 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, 52

Population: Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Baseline	77.569 picograms/milliliter (pg/mL)	Standard Deviation 278.376
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 0.25	-15.309 picograms/milliliter (pg/mL)	Standard Deviation 108.157
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 0.5	-16.181 picograms/milliliter (pg/mL)	Standard Deviation 116.587
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 2	17.998 picograms/milliliter (pg/mL)	Standard Deviation 157.295
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 5	17.265 picograms/milliliter (pg/mL)	Standard Deviation 186.212
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 3	-12.801 picograms/milliliter (pg/mL)	Standard Deviation 198.038
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 6	-0.412 picograms/milliliter (pg/mL)	Standard Deviation 271.409
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 12	-45.569 picograms/milliliter (pg/mL)	Standard Deviation 294.169
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 84.25	32.644 picograms/milliliter (pg/mL)	Standard Deviation 65.094
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 84.5	-46.575 picograms/milliliter (pg/mL)	Standard Deviation 318.217
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 86	-53.35 picograms/milliliter (pg/mL)	Standard Deviation 285.831
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 88	-42.836 picograms/milliliter (pg/mL)	Standard Deviation 280.041
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 90	-51.899 picograms/milliliter (pg/mL)	Standard Deviation 299.59
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 15	-21.565 picograms/milliliter (pg/mL)	Standard Deviation 312.758
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 27	-16.408 picograms/milliliter (pg/mL)	Standard Deviation 293.156
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 36	-38.921 picograms/milliliter (pg/mL)	Standard Deviation 303.851
TCZ SC 162 mg Q3W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 52	-44.611 picograms/milliliter (pg/mL)	Standard Deviation 289.698
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 36	13.273 picograms/milliliter (pg/mL)	Standard Deviation 24.814
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 84.25	14.66 picograms/milliliter (pg/mL)	Standard Deviation 24.026
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 15	122.88 picograms/milliliter (pg/mL)	—
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 84.5	24.478 picograms/milliliter (pg/mL)	Standard Deviation 31.747
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 85	27.934 picograms/milliliter (pg/mL)	Standard Deviation 53.23
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Baseline	10.567 picograms/milliliter (pg/mL)	Standard Deviation 11.24
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 44	14.765 picograms/milliliter (pg/mL)	Standard Deviation 18.458
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 0.25	4.575 picograms/milliliter (pg/mL)	Standard Deviation 7.555
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 86	36.06 picograms/milliliter (pg/mL)	Standard Deviation 82.547
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 0.5	11.932 picograms/milliliter (pg/mL)	Standard Deviation 13.33
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 28	14.206 picograms/milliliter (pg/mL)	Standard Deviation 20.762
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 2	23.223 picograms/milliliter (pg/mL)	Standard Deviation 23.935
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 88	19.397 picograms/milliliter (pg/mL)	Standard Deviation 22.712
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 5	35.263 picograms/milliliter (pg/mL)	Standard Deviation 64.907
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 2	21.751 picograms/milliliter (pg/mL)	Standard Deviation 49.964
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 52	10.401 picograms/milliliter (pg/mL)	Standard Deviation 18.455
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 4	15.944 picograms/milliliter (pg/mL)	Standard Deviation 26.322
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Day 90	20.642 picograms/milliliter (pg/mL)	Standard Deviation 20.247
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 6	17.841 picograms/milliliter (pg/mL)	Standard Deviation 34.515
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 14	11.958 picograms/milliliter (pg/mL)	Standard Deviation 16.665
TCZ SC 162 mg Q2W	Change From Baseline in Serum Interleukin-6 (IL-6) Levels	Week 12	17.236 picograms/milliliter (pg/mL)	Standard Deviation 28.727

Secondary

Change From Baseline in Soluble IL-6 Receptor Levels

Time frame: 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, 52

Arm	Measure	Group	Value (MEAN)	Dispersion
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 5	194.46 nanograms per milliliter (ng/mL)	Standard Deviation 143.28
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 0.5	-1.45 nanograms per milliliter (ng/mL)	Standard Deviation 53.39
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 86	461.19 nanograms per milliliter (ng/mL)	Standard Deviation 345.97
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 0.25	-4.04 nanograms per milliliter (ng/mL)	Standard Deviation 41.14
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 88	514.89 nanograms per milliliter (ng/mL)	Standard Deviation 303.29
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 3	418.54 nanograms per milliliter (ng/mL)	Standard Deviation 237.02
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 90	494.05 nanograms per milliliter (ng/mL)	Standard Deviation 276.35
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 6	407.36 nanograms per milliliter (ng/mL)	Standard Deviation 344.44
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 2	89.72 nanograms per milliliter (ng/mL)	Standard Deviation 75.29
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 15	497.21 nanograms per milliliter (ng/mL)	Standard Deviation 295.29
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 12	464.77 nanograms per milliliter (ng/mL)	Standard Deviation 317.77
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 27	532.81 nanograms per milliliter (ng/mL)	Standard Deviation 270.07
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Baseline	140.4 nanograms per milliliter (ng/mL)	Standard Deviation 225.72
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 36	416.02 nanograms per milliliter (ng/mL)	Standard Deviation 305.07
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 84.25	461.85 nanograms per milliliter (ng/mL)	Standard Deviation 280.99
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 4	323.4 nanograms per milliliter (ng/mL)	—
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 52	470.6 nanograms per milliliter (ng/mL)	Standard Deviation 263.38
TCZ SC 162 mg Q3W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 84.5	482.55 nanograms per milliliter (ng/mL)	Standard Deviation 299.43
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 36	269.32 nanograms per milliliter (ng/mL)	Standard Deviation 276.03
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 44	243.93 nanograms per milliliter (ng/mL)	Standard Deviation 299.72
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 4	239.86 nanograms per milliliter (ng/mL)	Standard Deviation 194.47
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 52	209.51 nanograms per milliliter (ng/mL)	Standard Deviation 318.38
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Baseline	206.7 nanograms per milliliter (ng/mL)	Standard Deviation 241.69
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 0.25	1.78 nanograms per milliliter (ng/mL)	Standard Deviation 29.68
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 0.5	4.58 nanograms per milliliter (ng/mL)	Standard Deviation 51.71
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 2	68.90 nanograms per milliliter (ng/mL)	Standard Deviation 66.75
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 5	124.65 nanograms per milliliter (ng/mL)	Standard Deviation 100.58
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 2	193.25 nanograms per milliliter (ng/mL)	Standard Deviation 158.69
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 6	233.82 nanograms per milliliter (ng/mL)	Standard Deviation 234.92
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 12	286.06 nanograms per milliliter (ng/mL)	Standard Deviation 260.33
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 84.25	245.05 nanograms per milliliter (ng/mL)	Standard Deviation 253.45
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 84.5	274.85 nanograms per milliliter (ng/mL)	Standard Deviation 230.86
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 85	268.72 nanograms per milliliter (ng/mL)	Standard Deviation 254.46
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 86	244.53 nanograms per milliliter (ng/mL)	Standard Deviation 257.08
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 88	256.47 nanograms per milliliter (ng/mL)	Standard Deviation 234.7
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Day 90	292.29 nanograms per milliliter (ng/mL)	Standard Deviation 229.2
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 14	272.93 nanograms per milliliter (ng/mL)	Standard Deviation 241.9
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 15	200 nanograms per milliliter (ng/mL)	—
TCZ SC 162 mg Q2W	Change From Baseline in Soluble IL-6 Receptor Levels	Week 28	295.28 nanograms per milliliter (ng/mL)	Standard Deviation 286.78

Secondary

Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential

Time frame: Baseline up to Week 52

Population: Safety population.

Arm	Measure	Value (NUMBER)
TCZ SC 162 mg Q3W	Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential	3.7 percentage of participants
TCZ SC 162 mg Q2W	Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential	8.0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026

A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment

Maximum Serum Concentration (Cmax) of TCZ at Steady State

Minimum Serum Concentration (Cmin) of TCZ at Steady State

Change From Baseline in C-Reactive Protein (CRP) Levels

Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

Change From Baseline in Serum Interleukin-6 (IL-6) Levels

Change From Baseline in Soluble IL-6 Receptor Levels

Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential