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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000444-10 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Tocilizumab (TCZ) Q2W | Experimental | Participants will receive 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. |
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| Part 2: TCZ IV 12 mg/kg Q3W/Q4W | Experimental | Participants with weight < 30 kg will receive 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 complete 5 consecutive infusions of Q3W and have a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality will switch to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study. |
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| Part 2: TCZ IV 8 mg/kg Q3W/Q4W | Experimental | Participants with weight >/= 30 kg will receive 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 complete 5 consecutive infusions of Q3W and have a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality will switch to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Part 2: Up to 52 weeks |
| 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. | Part 2: Up to 52 weeks |
| Number of Participants With Fever Attributable to Systemic Juvenile Idiopathic Arthritis (sJIA) in Part 2 of the Study |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
PART 1 and 2
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles; Division of Rheumatoogy | Los Angeles | California | 90027 | United States | ||
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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2016 |
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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.
| Part 2: Up to 52 weeks |
| 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 |
| 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 |
| 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 |
| 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. | Baseline of Part 2 |
| 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. | 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 |
| 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). | Baseline of Part 2 |
| 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. | 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 |
| Cincinnati Children'S Hospital Medical Center; Division of Rheumatology |
| Cincinnati |
| Ohio |
| 45229-3039 |
| United States |
| Hospital Gral de Niños Pedro Elizalde | Buenos Aires | 1270 | Argentina |
| Hospital Dr. Humberto Notti | Mendoza | 5519 | Argentina |
| Alberta Children'S Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| Charité Campus; Virchow Klinikum Berlin | Berlin | 13353 | Germany |
| Asklepios Klinik; Zentrum für Allgemeine Pädiatrie und Neonatologie | Sankt Augustin | 53757 | Germany |
| Rambam Medicl Center, Ruth Children Hospital | Haifa | 3109601 | Israel |
| Meir Medical center, Pediatrics | Kfar Saba | 4428164 | Israel |
| Schneider Children's Medical Center of Israel | Petah Tikva | 4920235 | Israel |
| Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina | Rome | Lazio | 00165 | Italy |
| Univ. Di Padova - Dip. Di Pediatria - Unita' Reumatol. Pediatrica | Padova | Veneto | 35128 | Italy |
| Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel | Mexicali | 21100 | Mexico |
| SI Sceintific children health center RAMS | Moscow | 119991 | Russia |
| Saint-Petersburg State; Pediatrics Medical Academy | Saint Petersburg | 194100 | Russia |
| Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica | Barcelona | 08950 | Spain |
| Hospital Ramon y Cajal ; Servicio de Reumatologia | Madrid | 28034 | Spain |
| Hospital de La Paz; Unidad de Reumatologia Pediatrica | Madrid | 28046 | Spain |
| Royal Liverpool Childrens Hospital; Rheumatology | Liverpool | L12 2AP | United Kingdom |
| 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Part 2 |
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Part 1 enrolled 19. Patients treated with TCZ Q2W either during Part 1 or prior to the study, who experienced laboratory abnormalities and which had resolved, were allowed to enroll into Part 2. Part 2 enrolled 22 with 6 from Part 1 and 16 directly enrolled into Part 2. Baseline Characteristics are presented separately for Part 1 and Part 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Part 1 participants | Part 1 of the study had 19 enrolled participants. | Mean | Standard Deviation | years |
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| Age, Continuous | Part 2 participants | Part 2 of the study had 22 enrolled participants, 6 of whom had completed Part 1 and 16 directly enrolled into Part 2. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Part 1 participants | Part 1 of the study had 19 enrolled participants. | Count of Participants | Participants |
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| Sex: Female, Male | Part 2 participants | Part 2 of the study had 22 enrolled participants, 6 of whom had completed Part 1 and 16 directly enrolled into Part 2. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Part 1 participants | Part 1 of the study had 19 enrolled participants. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Part 2 participants | Part 2 of the study had 22 enrolled participants, 6 of whom had completed Part 1 and 16 directly enrolled into Part 2. | Count of Participants | Participants |
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| Race (NIH/OMB) | Part 1 participants | Part 1 of the study had 19 enrolled participants. | Count of Participants | Participants |
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| Race (NIH/OMB) | Part 2 participants | Part 2 of the study had 22 enrolled participants, 6 of whom had completed Part 1 and 16 directly enrolled into Part 2. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Part 2: Up to 52 weeks |
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| 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. | 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. | Posted | Count of Participants | Participants | Part 2: Up to 52 weeks |
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| 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. | All TCZ population, all participants who have received at least one dose of study drug. | Posted | Count of Participants | Participants | Part 2: Up to 52 weeks |
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| 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. | 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. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study | 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. | Posted | Mean | Standard Deviation | pg/mL | 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 |
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| Secondary | Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study | 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 | Posted | Mean | Standard Deviation | ngEq/mL | 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 |
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| Secondary | C-reactive Protein (CRP) Concentration in Part 2 of the Study | 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. | Posted | Mean | Standard Deviation | mg/L | 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 |
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| Secondary | Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study | 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. | Posted | Mean | Standard Deviation | mm/h | 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 |
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| Secondary | Number of Participants With Anti-TCZ Antibodies in Part 2 of the Study | 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. | Posted | Count of Participants | Participants | Part 2: Up to Week 52 |
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| Secondary | Serum TCZ Concentration in Part 2 of the Study | 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. | Posted | Mean | Standard Deviation | ug/mL | 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 |
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| 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. | All TCZ population, all participants who have received at least one dose of study drug. | Posted | Mean | Standard Deviation | score on a scale | Baseline of Part 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| 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). | All TCZ population, all participants who have received at least one dose of study drug. | Posted | Mean | Standard Deviation | score on a scale | Baseline of Part 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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Part 1 - Up to 24 weeks plus 12 weeks safety follow up; Part 2 - Up to 52 weeks plus 12 weeks safety follow up
Safety population, all participants who received at least one dose of study drug and who had at least one post-baseline assessment of safety.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 19 | 1 | 19 | 16 | 19 |
| EG001 | 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. | 0 | 7 | 1 | 7 | 7 | 7 |
| EG002 | 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. | 0 | 15 | 1 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPERTRANSAMINASAEMIA | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ***NO CODING AVAILABLE*** | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EAR SWELLING | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| ENTEROBIASIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| MYCOPLASMA INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PARONYCHIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| VIRAL RASH | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| TRAUMATIC HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| COMPLEMENT FACTOR C4 DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| EOSINOPHIL COUNT INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| LIVER FUNCTION TEST INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| LYMPHOCYTE MORPHOLOGY ABNORMAL | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| POLYARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| STILL'S DISEASE | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SYNOVIAL CYST | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| FEAR OF INJECTION | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DYSMENORRHOEA | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CATARRH | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| TONSILLAR HYPERTROPHY | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INGROWING NAIL | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PETECHIAE | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CATARACT SUBCAPSULAR | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EYE PAIN | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANAL FISSURE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ASYMPTOMATIC BACTERIURIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| FUNGAL SKIN INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| IMPETIGO | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| OTITIS EXTERNA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA MYCOPLASMAL | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| TONSILLITIS STREPTOCOCCAL | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| ROSEOLOVIRUS TEST POSITIVE | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| VITAMIN D DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PRURIGO | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Apr 9, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided
| Other |
|
| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Week 0 |
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| Week 8 |
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| Week 9 |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Week 40 |
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| Week 48 |
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| Week 51 |
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| Part 2: TCZ IV 8 mg/kg Q3W |
Participants received tocilizumab 8 mg/kg IV infusions Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. |
| OG002 | Part 2: TCZ IV 12 mg/kg Q4W | 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 Q4W up to Week 52 in Part 2 of the study. |
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
|
|
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
|
|
| OG002 | 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. |
|
|
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
|
|
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
|
|
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
|
|
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
|
|
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. |
|
|
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
|
|
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 Q4W up to Week 52 in Part 2 of the study. |
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
|
|
| OG002 | Part 2: TCZ IV 12 mg/kg Q4W | 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 Q4W up to Week 52 in Part 2 of the study. |
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
|
|
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
|
|
| OG002 |
| Part 2: TCZ IV 12 mg/kg Q4W |
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 Q4W up to Week 52 in Part 2 of the study. |
| OG003 | Part 2: TCZ IV 8 mg/kg Q4W | 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. |
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