Juvenile Idiopathic Arthritis
Conditions
Brief summary
PART1 Participants in Part 1 (Run-in-Phase) of study will receive tocilizumab (TCZ) (RoActemra/Actemra) 12 milligrams per kilogram (mg/kg) or 8 mg/kg intravenously (IV) every 2 weeks (Q2W) for up to 24 weeks. Participants who experience a laboratory abnormality during Part 1 may be eligible to move into Part 2 of the study. PART 2 This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of tocilizumab in reduced dose frequency in participants with adequately controlled systemic juvenile idiopathic arthritis who have experienced a laboratory abnormality on twice weekly tocilizumab dosing, that has since resolved. Participants will receive tocilizumab 12 mg/kg or 8 mg/kg intravenously every 3 weeks. After 5 consecutive infusions, participants who experience an event of neutropenia, thrombocytopenia or liver enzyme abnormality will move to every 4 weeks tocilizumab administration. Anticipated time on study treatment is 52 weeks.
Interventions
DRUGTocilizumab
Participants will receive tocilizumab IV infusions of 12 mg/kg (for participants \< 30 kg) or 8 mg/kg (for participants \>/=30 kg) Q2W/Q3W/Q4W.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
PART 1 and 2 * Children 2 to 17 years of age inclusive at screening * Systemic juvenile idiopathic arthritis (sJIA) according to International League of Associations for Rheumatology (ILAR) classification (2001) and sJIA symptoms lasting for at least 1 month since diagnosis of sJIA * Must meet one of the following: * Not receiving methotrexate (MTX) or discontinued MTX at least 4 weeks prior to baseline visit, or * Taking MTX for at least 12 weeks immediately prior to the baseline visit and on a stable dose of less than or equals (\</=) 20 milligrams per meter square (mg/m\^2) for at least 8 weeks prior to the baseline visit, together with either folic acid or folinic acid according to local standard of care * Participants entering Part 1 who are naive to TCZ therapy must also meet the following inclusion criterion: * History of inadequate clinical response (in the opinion of the treating physician) to Non steroidal Anti-Inflammatory Drugs (NSAIDs) and corticosteroids PART 2 * Juvenile Arthritis Disease Activity Score (JADAS) -71 score of 3.8 or less and absence of fever (related to sJIA) at screening and baseline * Neutropenia, thrombocytopenia, or elevated Alanine transaminase/Aspartate transaminase (ALT/AST) previously experienced on the labeled dose (Q2W) of RoActemra/Actemra at any time * Not currently receiving oral corticosteroids, or taking oral corticosteroids at a stable dose for a minimum of 2 weeks prior to baseline visit at no more than 10 milligrams per day (mg/day) or 0.2 miiligrams per kilogram per day (mg/kg/day), whichever is less * Not taking (NSAIDs), or taking no more than 1 type of NSAID at a stable dose for a minimum of 2 weeks prior to the baseline visit, with the dose being less than or equal to the maximum recommended daily dose
Exclusion criteria
* Wheelchair bound or bedridden * Any other auto-immune, rheumatic disease, or overlap syndrome other than sJIA * Pregnant or lactating, or intending to become pregnant during study conduct and up to 6 months after the last administration of study drug * Any significant concurrent medical or surgical condition which would jeopardize the participant's safety or ability to complete the trial * History of significant allergic or infusion reactions to prior TCZ infusion, and/or presence of anti-TCZ antibodies at screening * Inborn conditions characterized by a compromised immune system * Known Human Immunodeficiency Virus (HIV) infection or other acquired forms of immune compromise * History of alcohol, drug, or chemical abuse within 6 months of screening * Evidence of serious uncontrolled concomitant diseases, including but not limited to the nervous, renal, hepatic, or endocrine systems * Any active acute, subacute, chronic or recurrent bacterial, viral, or systemic fungal infection * History of atypical tuberculosis (TB) * Active TB requiring treatment within 2 years prior to the screening visit * Positive purified protein derivative (PPD) at screening * Any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completing within 4 weeks of the screening visit or oral antibiotics completing within 2 weeks of the screening visit * History of reactivation or new onset of a systemic infection within 2 months of the screening visit * Positive for hepatitis B or hepatitis C infection * Chronic hepatitis, viral or pulmonary disease * Significant cardiac or pulmonary disease * History of or current cancer or lymphoma * Uncontrolled diabetes mellitus * History of or concurrent serious gastrointestinal disorders * History of macrophage activation syndrome (MAS) within 3 months prior to screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Juvenile Arthritis Disease Activity Score (JADAS-71) | Part 2: Up to 52 weeks | JADAS-71 has 4 components: Physician global assessment of disease activity on a visual analog scale (VAS) (range=0-10, left end of line=arthritis inactive, i.e., symptom-free and no arthritis symptoms; right end=arthritis very active), patient/parent global assessment of overall well-being on VAS (range=0-10, left end of line=very well, right end=very poor), normalized erythrocyte sedimentation rate (ESR) (range=0-10, If ESR is ≤20 mm/h, set to 0. If ≥120 mm/h, set to 10 mm/h. If \> 20 mm/h and \< 120 mm/h, apply formula: \[ESR-20 mm/h\]/10 mm/h), and a count of active arthritis (swelling present or pain present and limitation of motion) in 71 selected joints (range=0-71). JADAS-71 is sum of 4 component scores, range=0-101. A higher score=more arthritis disease activity. Data reported for up to Week 52 was collected in Part 2: Q3W arms: Baseline, Weeks 3,6,9,12,24,36,48 and 51; Q4W arms: Baseline, Weeks 0,4,8,12,24,36 and 40. |
| Number of Participants With Juvenile Idiopathic Arthritis (JIA) Disease Flare as Determined by JIA Core Variables in Part 2 of the Study | Part 2: Up to 52 weeks | JIA flare was defined as any 3 of the 6 core outcome variables worsening by at least 30% relative to baseline visit of Part 2, with no more than 1 of the remaining variables improving by more than 30%. For the number of joints with active arthritis or the number of joints with limitation of motion a minimum worsening of at least 2 joints had to be present. If the physician global assessment (PGA) or the parent/patient global assessment were used a minimum worsening of at least 2 units on a scale from 0 to 10 had be present. For erythrocyte sedimentation rate (ESR), a worsening of at least 30% was not considered if within normal ranges. The 6 core outcome variables: PGA of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis, number of joints with limitation of movement, ESR (measure of acute phase reaction) and functional ability determined by Childhood Health Assessment Questionnaire (CHAQ) Disability Index. |
| Number of Participants With Fever Attributable to Systemic Juvenile Idiopathic Arthritis (sJIA) in Part 2 of the Study | Part 2: Up to 52 weeks | Absence of fever at screening visit was defined as a temperature measurement \< 38 degree centigrades (C). Presence of fever at each study visit was defined as a temperature measurement ≥ 38 C. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive Protein (CRP) Concentration in Part 2 of the Study | Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40 | — |
| Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40 | — |
| Number of Participants With Anti-TCZ Antibodies in Part 2 of the Study | Part 2: Up to Week 52 | — |
| Serum TCZ Concentration in Part 2 of the Study | Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40 | — |
| Number of Participants With at Least One Adverse Event | Part 1 - Baseline up to 24 weeks plus 12 weeks of safety follow up; Part 2 - Baseline up to 52 weeks plus 12 weeks of safety follow up | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
| Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Baseline; Part 2: Q3W arm groups - Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 and 51; Q4W arm groups - Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 | CHAQ- Disability Index consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on 4-point scale with range 0=no difficulty to 3=unable to do. To calculate overall score, participant must have a domain score in at least 6 of 8 domains. Scores were averaged to calculate CHAQ disability index, range is 0=no/minimal physical dysfunction)-3=very severe physical dysfunction, higher score indicates more disability. Negative change from baseline indicates an improvement. |
| Baseline Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Baseline of Part 2 | Participant's/parent's global assessment of overall well-being was determined on a VAS (range = 0-100, left end of the line = very well, i.e., symptom-free and no arthritis disease activity; right end = very poor, i.e., maximum arthritis disease activity). |
| Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Baseline; Part 2: Q3W arm groups - Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 and 51; Q4W arm groups - Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 | Participant's/Parent's global assessment of overall well-being was determined on a VAS (range = 0-100, left end of the line = very well, i.e., symptom-free and no arthritis disease activity; right end = very poor, i.e., maximum arthritis disease activity). Reported is the change from baseline in VAS score with a negative change from baseline indicating an improvement. |
| Baseline Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Baseline of Part 2 | CHAQ- Disability Index consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on 4-point scale with range 0=no difficulty to 3=unable to do. To calculate overall score, participant must have a domain score in at least 6 of 8 domains. Scores were averaged to calculate CHAQ disability index, range is 0=no/minimal physical dysfunction)-3=very severe physical dysfunction, higher score indicates more disability. |
| Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40 | — |
| Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40 | — |
Countries
Argentina, Canada, Germany, Israel, Italy, Mexico, Russia, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants with systemic juvenile idiopathic arthritis (sJIA) were recruited at study sites in 8 countries. The study consisted of two parts: Part 1 was a 24-week Run-in period and Part 2 was a 52-week Main study.
Pre-assignment details
Participants on tocilizumab (TCZ) once every two weeks (Q2W) who had experienced a laboratory abnormality (which resolved) as per protocol criteria either during Part 1 or prior to the study, could enter Part 2. 19 Participants entered Part 1 and 6 continued on to Part 2. 16 participants directly entered Part 2 of the study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Tocilizumab (TCZ) Q2W Participants received tocilizumab intravenous (IV) infusions (12 mg/kg for participants \< 30 kg; 8 mg/kg for participants \>/= 30 kg) once every other week (Q2W) up to 24 weeks or until occurrence of a protocol defined laboratory abnormality in Part 1 of the study. | 19 |
| Part 2: TCZ IV 12 mg/kg Q3W/Q4W Participants with weight \< 30 kg received tocilizumab IV infusions of 12 mg/kg once every three weeks (Q3W) up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study. | 7 |
| Part 2: TCZ IV 8 mg/kg Q3W/Q4W Participants with weight \>/= 30 kg received tocilizumab IV infusions of 8 mg/kg Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study. | 15 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Part 1 | Adverse Event | 2 | 0 | 0 |
| Part 2 | Adverse Event | 0 | 0 | 1 |
| Part 2 | Lack of Efficacy | 0 | 1 | 1 |
| Part 2 | Other | 0 | 0 | 1 |
| Part 2 | Physician Decision | 0 | 0 | 3 |
| Part 2 | Protocol Violation | 0 | 1 | 0 |
| Part 2 | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Part 1: Tocilizumab (TCZ) Q2W | Part 2: TCZ IV 12 mg/kg Q3W/Q4W | Part 2: TCZ IV 8 mg/kg Q3W/Q4W |
|---|---|---|---|---|
| Age, Continuous | 8.5 years STANDARD_DEVIATION 3.6 | 8.5 years STANDARD_DEVIATION 3.6 | 6.7 years STANDARD_DEVIATION 1.8 | 11.7 years STANDARD_DEVIATION 2.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 0 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 13 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 0 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Female | 14 Participants | 9 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 0 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 7 | 0 / 15 |
| other Total, other adverse events | 16 / 19 | 7 / 7 | 14 / 15 |
| serious Total, serious adverse events | 1 / 19 | 1 / 7 | 1 / 15 |
Outcome results
Primary
Juvenile Arthritis Disease Activity Score (JADAS-71)
JADAS-71 has 4 components: Physician global assessment of disease activity on a visual analog scale (VAS) (range=0-10, left end of line=arthritis inactive, i.e., symptom-free and no arthritis symptoms; right end=arthritis very active), patient/parent global assessment of overall well-being on VAS (range=0-10, left end of line=very well, right end=very poor), normalized erythrocyte sedimentation rate (ESR) (range=0-10, If ESR is ≤20 mm/h, set to 0. If ≥120 mm/h, set to 10 mm/h. If \> 20 mm/h and \< 120 mm/h, apply formula: \[ESR-20 mm/h\]/10 mm/h), and a count of active arthritis (swelling present or pain present and limitation of motion) in 71 selected joints (range=0-71). JADAS-71 is sum of 4 component scores, range=0-101. A higher score=more arthritis disease activity. Data reported for up to Week 52 was collected in Part 2: Q3W arms: Baseline, Weeks 3,6,9,12,24,36,48 and 51; Q4W arms: Baseline, Weeks 0,4,8,12,24,36 and 40.
Time frame: Part 2: Up to 52 weeks
Population: All TCZ population, all participants who have received at least one dose of study drug. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 6 | 0.54 score on a scale | Standard Deviation 0.812 |
| Part 2: TCZ IV 12 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 48 | 0.00 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 12 | 0.30 score on a scale | Standard Deviation 0.6 |
| Part 2: TCZ IV 12 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 9 | 2.59 score on a scale | Standard Deviation 5.402 |
| Part 2: TCZ IV 12 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 36 | 0.48 score on a scale | Standard Deviation 0.95 |
| Part 2: TCZ IV 12 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 24 | 0.42 score on a scale | Standard Deviation 0.576 |
| Part 2: TCZ IV 12 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 3 | 1.60 score on a scale | Standard Deviation 2.474 |
| Part 2: TCZ IV 12 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 51 | 0.00 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Baseline | 0.60 score on a scale | Standard Deviation 0.839 |
| Part 2: TCZ IV 8 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 12 | 0.84 score on a scale | Standard Deviation 2.318 |
| Part 2: TCZ IV 8 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Baseline | 0.21 score on a scale | Standard Deviation 0.247 |
| Part 2: TCZ IV 8 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 3 | 0.61 score on a scale | Standard Deviation 0.913 |
| Part 2: TCZ IV 8 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 6 | 0.39 score on a scale | Standard Deviation 0.498 |
| Part 2: TCZ IV 8 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 9 | 0.33 score on a scale | Standard Deviation 0.42 |
| Part 2: TCZ IV 8 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 36 | 0.08 score on a scale | Standard Deviation 0.15 |
| Part 2: TCZ IV 8 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 48 | 0.17 score on a scale | Standard Deviation 0.289 |
| Part 2: TCZ IV 8 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 51 | 0.17 score on a scale | Standard Deviation 0.208 |
| Part 2: TCZ IV 8 mg/kg Q3W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 24 | 0.05 score on a scale | Standard Deviation 0.084 |
| Part 2: TCZ IV 12 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 12 | 0.00 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 0 | 0.00 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 24 | 0.00 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Baseline | 0.00 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 36 | 0.00 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 4 | 0.00 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 8 | 0.00 score on a scale | — |
| Part 2: TCZ IV 8 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 8 | 0.20 score on a scale | Standard Deviation 0.49 |
| Part 2: TCZ IV 8 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 4 | 0.17 score on a scale | Standard Deviation 0.266 |
| Part 2: TCZ IV 8 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 0 | 0.13 score on a scale | Standard Deviation 0.242 |
| Part 2: TCZ IV 8 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 24 | 0.20 score on a scale | Standard Deviation 0.346 |
| Part 2: TCZ IV 8 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 12 | 0.13 score on a scale | Standard Deviation 0.327 |
| Part 2: TCZ IV 8 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 40 | 0.00 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Week 36 | 0.00 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Juvenile Arthritis Disease Activity Score (JADAS-71) | Baseline | 0.35 score on a scale | Standard Deviation 0.295 |
Primary
Number of Participants With Fever Attributable to Systemic Juvenile Idiopathic Arthritis (sJIA) in Part 2 of the Study
Absence of fever at screening visit was defined as a temperature measurement \< 38 degree centigrades (C). Presence of fever at each study visit was defined as a temperature measurement ≥ 38 C.
Time frame: Part 2: Up to 52 weeks
Population: All TCZ population, all participants who have received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Number of Participants With Fever Attributable to Systemic Juvenile Idiopathic Arthritis (sJIA) in Part 2 of the Study | 0 Participants |
| Part 2: TCZ IV 8 mg/kg Q3W | Number of Participants With Fever Attributable to Systemic Juvenile Idiopathic Arthritis (sJIA) in Part 2 of the Study | 0 Participants |
| Part 2: TCZ IV 12 mg/kg Q4W | Number of Participants With Fever Attributable to Systemic Juvenile Idiopathic Arthritis (sJIA) in Part 2 of the Study | 0 Participants |
| Part 2: TCZ IV 8 mg/kg Q4W | Number of Participants With Fever Attributable to Systemic Juvenile Idiopathic Arthritis (sJIA) in Part 2 of the Study | 0 Participants |
Primary
Number of Participants With Juvenile Idiopathic Arthritis (JIA) Disease Flare as Determined by JIA Core Variables in Part 2 of the Study
JIA flare was defined as any 3 of the 6 core outcome variables worsening by at least 30% relative to baseline visit of Part 2, with no more than 1 of the remaining variables improving by more than 30%. For the number of joints with active arthritis or the number of joints with limitation of motion a minimum worsening of at least 2 joints had to be present. If the physician global assessment (PGA) or the parent/patient global assessment were used a minimum worsening of at least 2 units on a scale from 0 to 10 had be present. For erythrocyte sedimentation rate (ESR), a worsening of at least 30% was not considered if within normal ranges. The 6 core outcome variables: PGA of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis, number of joints with limitation of movement, ESR (measure of acute phase reaction) and functional ability determined by Childhood Health Assessment Questionnaire (CHAQ) Disability Index.
Time frame: Part 2: Up to 52 weeks
Population: All TCZ population, all participants who have received at least one dose of study drug. Number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Number of Participants With Juvenile Idiopathic Arthritis (JIA) Disease Flare as Determined by JIA Core Variables in Part 2 of the Study | 1 Participants |
| Part 2: TCZ IV 8 mg/kg Q3W | Number of Participants With Juvenile Idiopathic Arthritis (JIA) Disease Flare as Determined by JIA Core Variables in Part 2 of the Study | 3 Participants |
| Part 2: TCZ IV 12 mg/kg Q4W | Number of Participants With Juvenile Idiopathic Arthritis (JIA) Disease Flare as Determined by JIA Core Variables in Part 2 of the Study | 0 Participants |
| Part 2: TCZ IV 8 mg/kg Q4W | Number of Participants With Juvenile Idiopathic Arthritis (JIA) Disease Flare as Determined by JIA Core Variables in Part 2 of the Study | 1 Participants |
Secondary
Baseline Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study
CHAQ- Disability Index consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on 4-point scale with range 0=no difficulty to 3=unable to do. To calculate overall score, participant must have a domain score in at least 6 of 8 domains. Scores were averaged to calculate CHAQ disability index, range is 0=no/minimal physical dysfunction)-3=very severe physical dysfunction, higher score indicates more disability.
Time frame: Baseline of Part 2
Population: All TCZ population, all participants who have received at least one dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Baseline Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q3W | Baseline Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | 0.0417 score on a scale | Standard Deviation 0.09047 |
| Part 2: TCZ IV 12 mg/kg Q4W | Baseline Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | 0.0000 score on a scale | — |
| Part 2: TCZ IV 8 mg/kg Q4W | Baseline Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | 0.0000 score on a scale | Standard Deviation 0 |
Secondary
Baseline Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study
Participant's/parent's global assessment of overall well-being was determined on a VAS (range = 0-100, left end of the line = very well, i.e., symptom-free and no arthritis disease activity; right end = very poor, i.e., maximum arthritis disease activity).
Time frame: Baseline of Part 2
Population: All TCZ population, all participants who have received at least one dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Baseline Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | 2.3 score on a scale | Standard Deviation 3.95 |
| Part 2: TCZ IV 8 mg/kg Q3W | Baseline Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | 1.6 score on a scale | Standard Deviation 2.29 |
| Part 2: TCZ IV 12 mg/kg Q4W | Baseline Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | 0.0 score on a scale | — |
| Part 2: TCZ IV 8 mg/kg Q4W | Baseline Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | 2.5 score on a scale | Standard Deviation 3.21 |
Secondary
Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study
CHAQ- Disability Index consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on 4-point scale with range 0=no difficulty to 3=unable to do. To calculate overall score, participant must have a domain score in at least 6 of 8 domains. Scores were averaged to calculate CHAQ disability index, range is 0=no/minimal physical dysfunction)-3=very severe physical dysfunction, higher score indicates more disability. Negative change from baseline indicates an improvement.
Time frame: Baseline; Part 2: Q3W arm groups - Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 and 51; Q4W arm groups - Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Population: All TCZ population, all participants who have received at least one dose of study drug. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 36 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 33 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 21 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 9 | 0.2500 score on a scale | Standard Deviation 0.51539 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 30 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 27 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 6 | 0.1071 score on a scale | Standard Deviation 0.28347 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 3 | 0.2500 score on a scale | Standard Deviation 0.66144 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 51 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 48 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 24 | 0.1250 score on a scale | Standard Deviation 0.27951 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 12 | 0.1250 score on a scale | Standard Deviation 0.27951 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 45 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 42 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 39 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 15 | 0.1458 score on a scale | Standard Deviation 0.35722 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 18 | 0.1000 score on a scale | Standard Deviation 0.22361 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 12 | -0.0481 score on a scale | Standard Deviation 0.09599 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 3 | 0.0167 score on a scale | Standard Deviation 0.25384 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 6 | -0.0083 score on a scale | Standard Deviation 0.0742 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 9 | -0.0268 score on a scale | Standard Deviation 0.10022 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 15 | 0.1771 score on a scale | Standard Deviation 0.54994 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 24 | -0.0750 score on a scale | Standard Deviation 0.1118 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 30 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 33 | -0.0417 score on a scale | Standard Deviation 0.07217 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 36 | 0.0417 score on a scale | Standard Deviation 0.07217 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 39 | -0.0417 score on a scale | Standard Deviation 0.07217 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 42 | -0.0417 score on a scale | Standard Deviation 0.07217 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 45 | -0.0417 score on a scale | Standard Deviation 0.07217 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 48 | -0.0417 score on a scale | Standard Deviation 0.07217 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 51 | -0.0417 score on a scale | Standard Deviation 0.07217 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 18 | 0.2500 score on a scale | Standard Deviation 0.85009 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 21 | 0.2656 score on a scale | Standard Deviation 0.9074 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 27 | 0.0000 score on a scale | Standard Deviation 0.10206 |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 24 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 12 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 32 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 4 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 28 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 8 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 20 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 16 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 36 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 0 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 12 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 36 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 16 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 40 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 28 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 8 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 24 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 0 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 32 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 20 | 0.0000 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study | Change from Baseline at Week 4 | 0.0000 score on a scale | Standard Deviation 0 |
Secondary
Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study
Participant's/Parent's global assessment of overall well-being was determined on a VAS (range = 0-100, left end of the line = very well, i.e., symptom-free and no arthritis disease activity; right end = very poor, i.e., maximum arthritis disease activity). Reported is the change from baseline in VAS score with a negative change from baseline indicating an improvement.
Time frame: Baseline; Part 2: Q3W arm groups - Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 and 51; Q4W arm groups - Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Population: All TCZ population, all participants who have received at least one dose of study drug. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 48 | 0.0 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 30 | 0.0 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 27 | 0.0 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 18 | -1.4 score on a scale | Standard Deviation 3.71 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 6 | -1.6 score on a scale | Standard Deviation 3.51 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 24 | -1.8 score on a scale | Standard Deviation 4.02 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 21 | 0.0 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 3 | -0.3 score on a scale | Standard Deviation 2.36 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 45 | 0.0 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 42 | 0.0 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 9 | 8.4 score on a scale | Standard Deviation 26.48 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 39 | 0.3 score on a scale | Standard Deviation 0.5 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 12 | -1.6 score on a scale | Standard Deviation 3.58 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 51 | 0.0 score on a scale | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 36 | 0.3 score on a scale | Standard Deviation 0.5 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 33 | 25.0 score on a scale | Standard Deviation 50 |
| Part 2: TCZ IV 12 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 15 | -1.5 score on a scale | Standard Deviation 3.67 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 39 | -1.0 score on a scale | Standard Deviation 1.73 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 3 | 2.0 score on a scale | Standard Deviation 6.12 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 6 | 2.2 score on a scale | Standard Deviation 4.55 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 9 | 0.1 score on a scale | Standard Deviation 2.62 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 12 | -0.7 score on a scale | Standard Deviation 2.32 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 15 | 7.1 score on a scale | Standard Deviation 29.34 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 18 | 6.9 score on a scale | Standard Deviation 23.26 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 21 | 9.9 score on a scale | Standard Deviation 30.02 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 24 | -0.8 score on a scale | Standard Deviation 2.17 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 27 | 0.3 score on a scale | Standard Deviation 2.87 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 30 | -0.3 score on a scale | Standard Deviation 2.52 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 33 | 0.0 score on a scale | Standard Deviation 3 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 36 | 0.0 score on a scale | Standard Deviation 3 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 42 | -0.7 score on a scale | Standard Deviation 2.08 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 45 | 0.3 score on a scale | Standard Deviation 3.51 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 48 | 0.7 score on a scale | Standard Deviation 4.04 |
| Part 2: TCZ IV 8 mg/kg Q3W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 51 | 0.3 score on a scale | Standard Deviation 3.51 |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 4 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 0 | 0.0000 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 20 | 0.0 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 8 | 0.0 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 24 | 0.0 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 36 | 0.0 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 32 | 0.0 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 12 | 0.0 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 28 | 0.0 score on a scale | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 16 | 0.0 score on a scale | — |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 36 | -2.0 score on a scale | Standard Deviation 2.83 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 28 | -1.2 score on a scale | Standard Deviation 2.39 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 4 | -1.2 score on a scale | Standard Deviation 1.26 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 32 | 5.4 score on a scale | Standard Deviation 14.35 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 12 | -1.2 score on a scale | Standard Deviation 2.56 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 0 | -1.2 score on a scale | Standard Deviation 1.6 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 40 | -2.7 score on a scale | Standard Deviation 3.06 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 8 | -0.5 score on a scale | Standard Deviation 3.56 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 20 | -1.6 score on a scale | Standard Deviation 2.61 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 24 | -1.0 score on a scale | Standard Deviation 2 |
| Part 2: TCZ IV 8 mg/kg Q4W | Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study | Change from Baseline at Week 16 | -1.5 score on a scale | Standard Deviation 1.97 |
Secondary
C-reactive Protein (CRP) Concentration in Part 2 of the Study
Time frame: Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40
Population: Pharmacodynamic (PD) population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 9 | 0.208 mg/L | Standard Deviation 0.0179 |
| Part 2: TCZ IV 12 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 6 | 0.291 mg/L | Standard Deviation 0.1499 |
| Part 2: TCZ IV 12 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 51 | 0.318 mg/L | Standard Deviation 0.235 |
| Part 2: TCZ IV 12 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 48 | 0.200 mg/L | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 36 | 0.225 mg/L | Standard Deviation 0.05 |
| Part 2: TCZ IV 12 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 3 | 0.223 mg/L | Standard Deviation 0.0427 |
| Part 2: TCZ IV 12 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Baseline | 4.844 mg/L | Standard Deviation 12.2832 |
| Part 2: TCZ IV 12 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 24 | 0.280 mg/L | Standard Deviation 0.1789 |
| Part 2: TCZ IV 12 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 12 | 0.200 mg/L | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Baseline | 2.309 mg/L | Standard Deviation 6.9847 |
| Part 2: TCZ IV 8 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 3 | 0.216 mg/L | Standard Deviation 0.0407 |
| Part 2: TCZ IV 8 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 6 | 0.526 mg/L | Standard Deviation 1.0163 |
| Part 2: TCZ IV 8 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 9 | 0.255 mg/L | Standard Deviation 0.125 |
| Part 2: TCZ IV 8 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 12 | 0.238 mg/L | Standard Deviation 0.1201 |
| Part 2: TCZ IV 8 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 24 | 0.254 mg/L | Standard Deviation 0.1207 |
| Part 2: TCZ IV 8 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 36 | 0.200 mg/L | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 48 | 0.820 mg/L | Standard Deviation 1.0739 |
| Part 2: TCZ IV 8 mg/kg Q3W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 51 | 0.200 mg/L | Standard Deviation 0 |
| Part 2: TCZ IV 12 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 3 | 0.200 mg/L | — |
| Part 2: TCZ IV 12 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 36 | 0.200 mg/L | — |
| Part 2: TCZ IV 12 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Baseline | 0.200 mg/L | — |
| Part 2: TCZ IV 12 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 24 | 0.200 mg/L | — |
| Part 2: TCZ IV 12 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 8 | 0.200 mg/L | — |
| Part 2: TCZ IV 12 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 12 | 0.200 mg/L | — |
| Part 2: TCZ IV 12 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 4 | 0.200 mg/L | — |
| Part 2: TCZ IV 12 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 0 | 0.610 mg/L | — |
| Part 2: TCZ IV 12 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 9 | 0.200 mg/L | — |
| Part 2: TCZ IV 8 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 40 | 0.200 mg/L | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 0 | 0.200 mg/L | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 3 | 0.200 mg/L | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 12 | 0.203 mg/L | Standard Deviation 0.0082 |
| Part 2: TCZ IV 8 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 24 | 4.040 mg/L | Standard Deviation 8.5865 |
| Part 2: TCZ IV 8 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 9 | 0.200 mg/L | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Baseline | 0.958 mg/L | Standard Deviation 1.8575 |
| Part 2: TCZ IV 8 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 4 | 0.200 mg/L | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 36 | 0.200 mg/L | Standard Deviation 0 |
| Part 2: TCZ IV 8 mg/kg Q4W | C-reactive Protein (CRP) Concentration in Part 2 of the Study | Week 8 | 0.200 mg/L | Standard Deviation 0 |
Secondary
Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study
Time frame: Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40
Population: PD population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 3 | 2.86 mm/h | Standard Deviation 2.035 |
| Part 2: TCZ IV 12 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 51 | 1.75 mm/h | Standard Deviation 1.708 |
| Part 2: TCZ IV 12 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 12 | 2.20 mm/h | Standard Deviation 1.789 |
| Part 2: TCZ IV 12 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 36 | 2.25 mm/h | Standard Deviation 2.217 |
| Part 2: TCZ IV 12 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 48 | 3.00 mm/h | Standard Deviation 0.816 |
| Part 2: TCZ IV 12 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Baseline | 3.43 mm/h | Standard Deviation 5.192 |
| Part 2: TCZ IV 12 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 24 | 2.80 mm/h | Standard Deviation 1.304 |
| Part 2: TCZ IV 12 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 6 | 4.14 mm/h | Standard Deviation 4.598 |
| Part 2: TCZ IV 12 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 9 | 2.50 mm/h | Standard Deviation 2.51 |
| Part 2: TCZ IV 8 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 51 | 6.00 mm/h | Standard Deviation 3 |
| Part 2: TCZ IV 8 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Baseline | 3.00 mm/h | Standard Deviation 1.852 |
| Part 2: TCZ IV 8 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 12 | 3.92 mm/h | Standard Deviation 3.315 |
| Part 2: TCZ IV 8 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 48 | 4.67 mm/h | Standard Deviation 1.528 |
| Part 2: TCZ IV 8 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 9 | 3.23 mm/h | Standard Deviation 2.204 |
| Part 2: TCZ IV 8 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 36 | 4.50 mm/h | Standard Deviation 2.646 |
| Part 2: TCZ IV 8 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 3 | 3.57 mm/h | Standard Deviation 2.709 |
| Part 2: TCZ IV 8 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 6 | 4.13 mm/h | Standard Deviation 3.681 |
| Part 2: TCZ IV 8 mg/kg Q3W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 24 | 3.17 mm/h | Standard Deviation 2.137 |
| Part 2: TCZ IV 12 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 24 | 1.00 mm/h | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Baseline | 1.00 mm/h | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 0 | 4.00 mm/h | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 3 | 2.00 mm/h | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 4 | 1.00 mm/h | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 8 | 1.00 mm/h | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 9 | 3.00 mm/h | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 36 | 1.00 mm/h | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 12 | 1.00 mm/h | — |
| Part 2: TCZ IV 8 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 36 | 2.25 mm/h | Standard Deviation 1.893 |
| Part 2: TCZ IV 8 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 24 | 2.80 mm/h | Standard Deviation 1.789 |
| Part 2: TCZ IV 8 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 9 | 2.25 mm/h | Standard Deviation 0.957 |
| Part 2: TCZ IV 8 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 8 | 3.33 mm/h | Standard Deviation 2.16 |
| Part 2: TCZ IV 8 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 4 | 3.17 mm/h | Standard Deviation 1.722 |
| Part 2: TCZ IV 8 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Baseline | 3.17 mm/h | Standard Deviation 1.602 |
| Part 2: TCZ IV 8 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 12 | 4.50 mm/h | Standard Deviation 3.209 |
| Part 2: TCZ IV 8 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 3 | 2.75 mm/h | Standard Deviation 0.957 |
| Part 2: TCZ IV 8 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 0 | 2.67 mm/h | Standard Deviation 1.633 |
| Part 2: TCZ IV 8 mg/kg Q4W | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | Week 40 | 2.25 mm/h | Standard Deviation 1.893 |
Secondary
Number of Participants With Anti-TCZ Antibodies in Part 2 of the Study
Time frame: Part 2: Up to Week 52
Population: Safety population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of safety.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Number of Participants With Anti-TCZ Antibodies in Part 2 of the Study | 0 Participants |
| Part 2: TCZ IV 8 mg/kg Q3W | Number of Participants With Anti-TCZ Antibodies in Part 2 of the Study | 0 Participants |
| Part 2: TCZ IV 12 mg/kg Q4W | Number of Participants With Anti-TCZ Antibodies in Part 2 of the Study | 0 Participants |
| Part 2: TCZ IV 8 mg/kg Q4W | Number of Participants With Anti-TCZ Antibodies in Part 2 of the Study | 0 Participants |
Secondary
Number of Participants With at Least One Adverse Event
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Part 1 - Baseline up to 24 weeks plus 12 weeks of safety follow up; Part 2 - Baseline up to 52 weeks plus 12 weeks of safety follow up
Population: Safety population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of safety.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Number of Participants With at Least One Adverse Event | 16 Participants |
| Part 2: TCZ IV 8 mg/kg Q3W | Number of Participants With at Least One Adverse Event | 7 Participants |
| Part 2: TCZ IV 12 mg/kg Q4W | Number of Participants With at Least One Adverse Event | 14 Participants |
Secondary
Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study
Time frame: Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40
Population: Pharmacodynamic (PD) population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Baseline | 36.340 pg/mL | Standard Deviation 19.2413 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 3 | 61.617 pg/mL | Standard Deviation 75.5724 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 6 | 46.698 pg/mL | Standard Deviation 50.7148 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 9 | 45.231 pg/mL | Standard Deviation 46.2539 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 24 | 79.200 pg/mL | Standard Deviation 44.8853 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 36 | 67.467 pg/mL | Standard Deviation 84.7317 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 48 | 14.533 pg/mL | Standard Deviation 1.4154 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 51 | 17.523 pg/mL | Standard Deviation 9.2077 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 12 | 84.100 pg/mL | Standard Deviation 57.8972 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 9 | 47.582 pg/mL | Standard Deviation 37.2259 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 6 | 82.995 pg/mL | Standard Deviation 216.2854 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 48 | 15.400 pg/mL | Standard Deviation 10.0936 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 12 | 71.867 pg/mL | Standard Deviation 156.471 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 24 | 23.420 pg/mL | Standard Deviation 14.552 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 51 | 5.060 pg/mL | — |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 36 | 30.025 pg/mL | Standard Deviation 16.547 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Baseline | 23.453 pg/mL | Standard Deviation 12.144 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 3 | 22.727 pg/mL | Standard Deviation 7.0321 |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 24 | 45.000 pg/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 36 | 14.100 pg/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 4 | 13.700 pg/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 8 | 14.300 pg/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Baseline | 51.500 pg/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 12 | 11.600 pg/mL | — |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 0 | 33.000 pg/mL | Standard Deviation 23.3195 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 12 | 29.662 pg/mL | Standard Deviation 26.0053 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 8 | 30.580 pg/mL | Standard Deviation 22.0335 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 24 | 29.393 pg/mL | Standard Deviation 19.276 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 40 | 22.820 pg/mL | Standard Deviation 24.0133 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 4 | 28.364 pg/mL | Standard Deviation 24.8937 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Baseline | 25.415 pg/mL | Standard Deviation 15.0174 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | Week 36 | 21.500 pg/mL | Standard Deviation 15.8392 |
Secondary
Serum TCZ Concentration in Part 2 of the Study
Time frame: Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40
Population: All TCZ population in Part 2, all participants who have received at least one dose of study drug in Part 2. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Baseline | 29.916 ug/mL | Standard Deviation 35.8002 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 3 | 26.420 ug/mL | Standard Deviation 21.1844 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 6 | 28.636 ug/mL | Standard Deviation 13.5744 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 9 | 32.020 ug/mL | Standard Deviation 6.3739 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 36 | 30.517 ug/mL | Standard Deviation 18.6058 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 48 | 25.433 ug/mL | Standard Deviation 34.3053 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 51 | 12.207 ug/mL | Standard Deviation 8.5862 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 12 | 37.600 ug/mL | Standard Deviation 20.5254 |
| Part 2: TCZ IV 12 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 24 | 24.363 ug/mL | Standard Deviation 20.3686 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 48 | 22.950 ug/mL | Standard Deviation 0.9192 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 6 | 30.482 ug/mL | Standard Deviation 19.2402 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 36 | 19.733 ug/mL | Standard Deviation 8.2218 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 9 | 26.962 ug/mL | Standard Deviation 17.9122 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 24 | 20.842 ug/mL | Standard Deviation 25.9417 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 12 | 44.763 ug/mL | Standard Deviation 77.1798 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Baseline | 44.210 ug/mL | Standard Deviation 33.2547 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 3 | 37.239 ug/mL | Standard Deviation 21.8192 |
| Part 2: TCZ IV 8 mg/kg Q3W | Serum TCZ Concentration in Part 2 of the Study | Week 51 | 10.945 ug/mL | Standard Deviation 14.6449 |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Baseline | 9.520 ug/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 24 | 30.300 ug/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 8 | 22.800 ug/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 12 | 23.800 ug/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 36 | 19.800 ug/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 4 | 11.100 ug/mL | — |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 4 | 17.718 ug/mL | Standard Deviation 11.158 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 8 | 17.578 ug/mL | Standard Deviation 13.0611 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 24 | 16.030 ug/mL | Standard Deviation 14.2124 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 12 | 15.442 ug/mL | Standard Deviation 11.0714 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 36 | 12.903 ug/mL | Standard Deviation 11.1808 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 40 | 28.778 ug/mL | Standard Deviation 16.0031 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Baseline | 53.622 ug/mL | Standard Deviation 48.5163 |
| Part 2: TCZ IV 8 mg/kg Q4W | Serum TCZ Concentration in Part 2 of the Study | Week 0 | 24.212 ug/mL | Standard Deviation 13.1659 |
Secondary
Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study
Time frame: Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40
Population: Pharmacodynamic (PD) population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. Number analyzed is the number of participants with data available at the given timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: TCZ IV 12 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 51 | 651.00 ngEq/mL | Standard Deviation 135.765 |
| Part 2: TCZ IV 12 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 12 | 656.80 ngEq/mL | Standard Deviation 123.611 |
| Part 2: TCZ IV 12 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 6 | 518.67 ngEq/mL | Standard Deviation 272.217 |
| Part 2: TCZ IV 12 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 36 | 492.50 ngEq/mL | Standard Deviation 258.445 |
| Part 2: TCZ IV 12 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 24 | 574.54 ngEq/mL | Standard Deviation 347.127 |
| Part 2: TCZ IV 12 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 3 | 632.43 ngEq/mL | Standard Deviation 261.172 |
| Part 2: TCZ IV 12 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Baseline | 621.04 ngEq/mL | Standard Deviation 443.779 |
| Part 2: TCZ IV 12 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 48 | 551.00 ngEq/mL | Standard Deviation 91 |
| Part 2: TCZ IV 12 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 9 | 596.58 ngEq/mL | Standard Deviation 318.685 |
| Part 2: TCZ IV 8 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 51 | 517.00 ngEq/mL | Standard Deviation 140.007 |
| Part 2: TCZ IV 8 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 3 | 707.73 ngEq/mL | Standard Deviation 291.228 |
| Part 2: TCZ IV 8 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 6 | 721.73 ngEq/mL | Standard Deviation 253.114 |
| Part 2: TCZ IV 8 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 9 | 646.92 ngEq/mL | Standard Deviation 174.932 |
| Part 2: TCZ IV 8 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 12 | 666.75 ngEq/mL | Standard Deviation 144.51 |
| Part 2: TCZ IV 8 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 24 | 554.33 ngEq/mL | Standard Deviation 124.498 |
| Part 2: TCZ IV 8 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 36 | 646.00 ngEq/mL | Standard Deviation 198.499 |
| Part 2: TCZ IV 8 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 48 | 391.00 ngEq/mL | Standard Deviation 220.293 |
| Part 2: TCZ IV 8 mg/kg Q3W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Baseline | 735.16 ngEq/mL | Standard Deviation 310.983 |
| Part 2: TCZ IV 12 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 12 | 411.00 ngEq/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 36 | 439.00 ngEq/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 8 | 434.00 ngEq/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 4 | 379.00 ngEq/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Baseline | 447.00 ngEq/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 0 | 72.50 ngEq/mL | — |
| Part 2: TCZ IV 12 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 24 | 519.00 ngEq/mL | — |
| Part 2: TCZ IV 8 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Baseline | 855.00 ngEq/mL | Standard Deviation 325.572 |
| Part 2: TCZ IV 8 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 12 | 645.33 ngEq/mL | Standard Deviation 106.952 |
| Part 2: TCZ IV 8 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 0 | 722.83 ngEq/mL | Standard Deviation 229.53 |
| Part 2: TCZ IV 8 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 24 | 546.25 ngEq/mL | Standard Deviation 330.265 |
| Part 2: TCZ IV 8 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 36 | 599.75 ngEq/mL | Standard Deviation 122.2 |
| Part 2: TCZ IV 8 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 40 | 609.50 ngEq/mL | Standard Deviation 115.613 |
| Part 2: TCZ IV 8 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 8 | 628.50 ngEq/mL | Standard Deviation 145.891 |
| Part 2: TCZ IV 8 mg/kg Q4W | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | Week 4 | 653.00 ngEq/mL | Standard Deviation 143.386 |