Juvenile Idiopathic Arthritis
Conditions
Brief summary
This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
Interventions
DRUGtocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 104 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients 9 to 18 years of age who completed visit 33 (week 104) of WA19977 study with at least JIA ACR30 clinical response to RoActemra/Actemra relative to baseline in WA19977, with no AEs, SAEs or conditions that lead to unacceptable risk of continued treatment * Scheduled to receive first RoActemra/Actemra infusion in this study between 4 and 6 weeks after the last IV infusion in the core study * Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
Exclusion criteria
* Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977 * Treatment with any investigational agent since the last administration of study drug in the core study WA19977 or current participation in another clinical trial except WA19977 * Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA * Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug * Any significant concomitant disease or medical or surgical condition * History of significant allergic or infusion reactions to prior biologic therapy * Known current active acute, subacute, chronic or history of recurrent infection; patients suffering from ongoing active infections with Epstein Barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided * Positive for latent tuberculosis (TB) * Currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for \>/= 2 weeks within 6 months prior to entering the study * Inadequate hepatic, renal or bone marrow function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events | Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks) | Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab. AEs of special interest were Infections (including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related events, Malignancies, Anaphylaxis/Hypersensitivity reactions, Demyelinating disorders, Stroke. Bleeding events, Hepatic events and Macrophage activation syndrome (MAS). |
| Number of AEs of Special Interest and Study Drug Related AEs | Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks) | AEs and SAEs were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Baseline, Screening, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks) | CR was defined as clinical remission with medication (CRem). A participant was in CR if inactive disease was observed for a minimum of 6 consecutive months. |
| Physicians Assessment of Global Activity (VAS) | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) | The participant's treating physician provided a rating of the participant's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line, score 0 represented 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end score 100 represented 'arthritis very active'. A higher score indicated more disease activity. |
| Parent or Participant's Assessment of Global Activity (VAS) | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) | The participant or parent/guardian, as appropriate, provided a rating of the participant's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line Score 0 represented 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end score 100 represented 'very poor' (ie, maximum arthritis disease activity). A higher score indicated poorer well-being. |
| Number of Joints With Active Arthritis | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) | Joints with active arthritis were defined as joints with swelling or pain and limited of motion. The maximum number of joints with active arthritis was 71.The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant's efficacy and safety data. |
| Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) | The six JIA ACR components comprised of: 1) Physician's global assessment of disease activity, 2) Parent/Participant's global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP), and 6) Childhood Health Assessment Questionnaire - Disease Index (CHAQ-DI). At an assessment visit, a JIA ACR30/50/70/90 response in comparison to Baseline was defined as: At least three of the six JIA ACR core components improving by at least 30 percent (%), 50%, 70%, or 90% respectively and no more than one of the remaining JIA ACR core components worsening by more than 30%. |
| Erythrocyte Sedimentation Rate | Baseline, Weeks 4, 8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks) | ESR is a marker of inflammation and was measured as millimeters per hour (mm/h). Healthy individuals have low ESR. Higher ESR indicate inflammation. |
| CHAQ-DI Score | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks) | The CHAQ-DI questionnaire consisted of 30 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain had at least two component questions and if applicable to the participant there were four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst). |
| Parent or Participant's Assessment of Pain (VAS) | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks) | Parents or participants rated participant's pain by placing a horizontal line on a VAS of 0 (no pain)- 100 mm (severe pain). |
| CRP Levels | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Follow-Up Visit (up to 82 weeks) | CRP an acute phase protein, is a marker of inflammation. CRP was measured as milligrams per deciliter (mg/dL). |
| Number of Joints With Lack of Motion | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) | Joints with lack of movement were assessed. The maximum number of joints with lack of movement was 67. The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant's efficacy and safety data. |
| Percentage of Participants With Inactive Disease by Visit | Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) | A participant was defined to show inactive disease if all of the following criteria were applied: 1) No joints with active arthritis (no joints with swelling and no joints with lack of motion), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) Physician's global assessment of disease activity equals (=) 0 millimeters (mm) on a Visual analog scale (VAS). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab 8 mg/kg Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Tocilizumab 8 mg/kg |
|---|---|
| Age, Continuous | 14.4 years STANDARD_DEVIATION 3.2 |
| Gender Female | 6 Participants |
| Gender Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 1 / 7 |
Outcome results
Primary
Number of AEs of Special Interest and Study Drug Related AEs
AEs and SAEs were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab.
Time frame: Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Number of AEs of Special Interest and Study Drug Related AEs | Drug related AEs | 22 adverse events |
| Tocilizumab | Number of AEs of Special Interest and Study Drug Related AEs | Drug related SAEs | 0 adverse events |
| Tocilizumab | Number of AEs of Special Interest and Study Drug Related AEs | AEs of special interest | 2 adverse events |
| Tocilizumab | Number of AEs of Special Interest and Study Drug Related AEs | Drug-related AEs of special interest | 2 adverse events |
Primary
Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events
Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab. AEs of special interest were Infections (including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related events, Malignancies, Anaphylaxis/Hypersensitivity reactions, Demyelinating disorders, Stroke. Bleeding events, Hepatic events and Macrophage activation syndrome (MAS).
Time frame: Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events | Drug related AEs | 6 participants |
| Tocilizumab | Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events | Drug related SAEs | 0 participants |
| Tocilizumab | Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events | AEs of special interest | 1 participants |
| Tocilizumab | Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events | Drug-related AEs of special interest | 1 participants |
Secondary
CHAQ-DI Score
The CHAQ-DI questionnaire consisted of 30 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain had at least two component questions and if applicable to the participant there were four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst).
Time frame: Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; n = number of participants analyzed at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | CHAQ-DI Score | Baseline (n=7) | 0.0 score on a scale | Standard Deviation 0 |
| Tocilizumab | CHAQ-DI Score | Week 12 (n=7) | 0.04 score on a scale | Standard Deviation 0.09 |
| Tocilizumab | CHAQ-DI Score | Week 24 (n=7) | 0.14 score on a scale | Standard Deviation 0.2 |
| Tocilizumab | CHAQ-DI Score | Week 28 (n=1) | 0.00 score on a scale | Standard Deviation 0 |
| Tocilizumab | CHAQ-DI Score | Week 32 (n=2) | 0.19 score on a scale | Standard Deviation 0.27 |
| Tocilizumab | CHAQ-DI Score | Week 36 (n=7) | 0.13 score on a scale | Standard Deviation 0.33 |
| Tocilizumab | CHAQ-DI Score | Week 48 (n=6) | 0.00 score on a scale | Standard Deviation 0 |
| Tocilizumab | CHAQ-DI Score | Week 60 (n=6) | 0.21 score on a scale | Standard Deviation 0.51 |
| Tocilizumab | CHAQ-DI Score | Week 72 (n=2) | 0.00 score on a scale | Standard Deviation 0 |
| Tocilizumab | CHAQ-DI Score | Follow-Up (n=7) | 0.00 score on a scale | Standard Deviation 0 |
Secondary
CRP Levels
CRP an acute phase protein, is a marker of inflammation. CRP was measured as milligrams per deciliter (mg/dL).
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; n = number of participants analyzed at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | CRP Levels | Baseline (n=7) | 0.03 mg/dL | Standard Deviation 0.01 |
| Tocilizumab | CRP Levels | Week 4 (n=7) | 0.05 mg/dL | Standard Deviation 0.07 |
| Tocilizumab | CRP Levels | Week 8 (n=7) | 0.02 mg/dL | Standard Deviation 0.02 |
| Tocilizumab | CRP Levels | Week 12 (n=7) | 0.03 mg/dL | Standard Deviation 0.01 |
| Tocilizumab | CRP Levels | Week 16 (n=7) | 0.23 mg/dL | Standard Deviation 0.54 |
| Tocilizumab | CRP Levels | Week 20 (n=7) | 0.05 mg/dL | Standard Deviation 0.07 |
| Tocilizumab | CRP Levels | Week 24 (n=7) | 0.03 mg/dL | Standard Deviation 0.02 |
| Tocilizumab | CRP Levels | Week 28 (n=6) | 0.02 mg/dL | Standard Deviation 0.02 |
| Tocilizumab | CRP Levels | Week 32 (n=7) | 0.03 mg/dL | Standard Deviation 0.02 |
| Tocilizumab | CRP Levels | Week 36 (n=7) | 0.02 mg/dL | Standard Deviation 0.02 |
| Tocilizumab | CRP Levels | Week 40 (n=6) | 0.03 mg/dL | Standard Deviation 0.02 |
| Tocilizumab | CRP Levels | Week 44 (n=6) | 0.03 mg/dL | Standard Deviation 0.02 |
| Tocilizumab | CRP Levels | Week 48 (n=6) | 0.03 mg/dL | Standard Deviation 0.02 |
| Tocilizumab | CRP Levels | Week 52 (n=6) | 0.02 mg/dL | Standard Deviation 0.02 |
| Tocilizumab | CRP Levels | Week 56 (n=6) | 0.03 mg/dL | Standard Deviation 0.02 |
| Tocilizumab | CRP Levels | Week 60 (n=6) | 0.38 mg/dL | Standard Deviation 0.9 |
| Tocilizumab | CRP Levels | Week 64 (n=5) | 0.03 mg/dL | Standard Deviation 0.03 |
| Tocilizumab | CRP Levels | Week 68 (n=3) | 0.09 mg/dL | Standard Deviation 0.1 |
| Tocilizumab | CRP Levels | Week 72 (n=2) | 0.04 mg/dL | Standard Deviation 0.04 |
| Tocilizumab | CRP Levels | Week 76 (n=1) | 0.05 mg/dL | Standard Deviation 0 |
| Tocilizumab | CRP Levels | Follow-Up (n=7) | 0.05 mg/dL | Standard Deviation 0.06 |
Secondary
Erythrocyte Sedimentation Rate
ESR is a marker of inflammation and was measured as millimeters per hour (mm/h). Healthy individuals have low ESR. Higher ESR indicate inflammation.
Time frame: Baseline, Weeks 4, 8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; n = number of participants analyzed at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 36 (n=7) | 4.3 mm/h | Standard Deviation 2.5 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 40 (n=6) | 2.0 mm/h | Standard Deviation 1.8 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Baseline (n=7) | 4.9 mm/h | Standard Deviation 5.1 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 4 (n=7) | 3.0 mm/h | Standard Deviation 1.9 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 8 (n=7) | 2.9 mm/h | Standard Deviation 2.3 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 12 (n=7) | 3.0 mm/h | Standard Deviation 2 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 16 (n=7) | 8.6 mm/h | Standard Deviation 16.1 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 20 (n=7) | 2.6 mm/h | Standard Deviation 0.8 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 24 (n=7) | 2.7 mm/h | Standard Deviation 1.4 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 28 (n=5) | 3.4 mm/h | Standard Deviation 3.1 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 32 (n=7) | 4.3 mm/h | Standard Deviation 4.2 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 44 (n=6) | 2.7 mm/h | Standard Deviation 1.5 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 48 (n=6) | 3.8 mm/h | Standard Deviation 1.5 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 52 (n=6) | 3.2 mm/h | Standard Deviation 3.6 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 56 (n=6) | 2.3 mm/h | Standard Deviation 1.6 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 60 (n=6) | 10.2 mm/h | Standard Deviation 12.7 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 64 (n=5) | 3.2 mm/h | Standard Deviation 2.4 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 68 (n=3) | 10.0 mm/h | Standard Deviation 7.2 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 72 (n=2) | 4.5 mm/h | Standard Deviation 0.7 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 76 (n=1) | 2.0 mm/h | Standard Deviation 0 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Follow-Up (n=7) | 4.3 mm/h | Standard Deviation 2.8 |
Secondary
Number of Joints With Active Arthritis
Joints with active arthritis were defined as joints with swelling or pain and limited of motion. The maximum number of joints with active arthritis was 71.The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant's efficacy and safety data.
Time frame: Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; n = number of participants analyzed at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Number of Joints With Active Arthritis | Week 72 (n=2) | 0.0 joints | Standard Deviation 0 |
| Tocilizumab | Number of Joints With Active Arthritis | Baseline (n=7) | 0.9 joints | Standard Deviation 2.3 |
| Tocilizumab | Number of Joints With Active Arthritis | Week 12 (n=7) | 0.3 joints | Standard Deviation 0.8 |
| Tocilizumab | Number of Joints With Active Arthritis | Week 24 (n=7) | 1.0 joints | Standard Deviation 2.6 |
| Tocilizumab | Number of Joints With Active Arthritis | Week 28 (n=1) | 1.0 joints | Standard Deviation 0 |
| Tocilizumab | Number of Joints With Active Arthritis | Week 32 (n=2) | 1.5 joints | Standard Deviation 0.7 |
| Tocilizumab | Number of Joints With Active Arthritis | Week 36 (n=7) | 1.1 joints | Standard Deviation 2.2 |
| Tocilizumab | Number of Joints With Active Arthritis | Week 48 (n=6) | 0.0 joints | Standard Deviation 0 |
| Tocilizumab | Number of Joints With Active Arthritis | Week 60 (n=6) | 0.3 joints | Standard Deviation 0.8 |
| Tocilizumab | Number of Joints With Active Arthritis | Follow-Up (n=7) | 0.3 joints | Standard Deviation 0.8 |
Secondary
Number of Joints With Lack of Motion
Joints with lack of movement were assessed. The maximum number of joints with lack of movement was 67. The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant's efficacy and safety data.
Time frame: Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; n = number of participants analyzed at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Number of Joints With Lack of Motion | Week 36 (n=7) | 1.7 joints | Standard Deviation 2.4 |
| Tocilizumab | Number of Joints With Lack of Motion | Baseline (n=7) | 1.4 joints | Standard Deviation 2.7 |
| Tocilizumab | Number of Joints With Lack of Motion | Week 12 (n=7) | 2.6 joints | Standard Deviation 5.1 |
| Tocilizumab | Number of Joints With Lack of Motion | Week 24 (n=7) | 2.4 joints | Standard Deviation 3.2 |
| Tocilizumab | Number of Joints With Lack of Motion | Week 28 (n=1) | 1.0 joints | Standard Deviation 0 |
| Tocilizumab | Number of Joints With Lack of Motion | Week 32 (n=2) | 5.5 joints | Standard Deviation 7.8 |
| Tocilizumab | Number of Joints With Lack of Motion | Week 48 (n=6) | 2.7 joints | Standard Deviation 5.2 |
| Tocilizumab | Number of Joints With Lack of Motion | Week 60 (n=6) | 1.8 joints | Standard Deviation 3 |
| Tocilizumab | Number of Joints With Lack of Motion | Week 72 (n=2) | 0.0 joints | Standard Deviation 0 |
| Tocilizumab | Number of Joints With Lack of Motion | Follow-Up (n=7) | 2.9 joints | Standard Deviation 4.8 |
Secondary
Parent or Participant's Assessment of Global Activity (VAS)
The participant or parent/guardian, as appropriate, provided a rating of the participant's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line Score 0 represented 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end score 100 represented 'very poor' (ie, maximum arthritis disease activity). A higher score indicated poorer well-being.
Time frame: Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; n = number of participants analyzed at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Parent or Participant's Assessment of Global Activity (VAS) | Baseline (n=7) | 10.1 mm | Standard Deviation 20 |
| Tocilizumab | Parent or Participant's Assessment of Global Activity (VAS) | Week 12 (n=7) | 7.1 mm | Standard Deviation 8.1 |
| Tocilizumab | Parent or Participant's Assessment of Global Activity (VAS) | Week 24 (n=7) | 16.4 mm | Standard Deviation 19.9 |
| Tocilizumab | Parent or Participant's Assessment of Global Activity (VAS) | Week 28 (n=1) | 1.0 mm | Standard Deviation 0 |
| Tocilizumab | Parent or Participant's Assessment of Global Activity (VAS) | Week 32 (n=2) | 22.5 mm | Standard Deviation 24.7 |
| Tocilizumab | Parent or Participant's Assessment of Global Activity (VAS) | Week 36 (n=7) | 12.1 mm | Standard Deviation 18.4 |
| Tocilizumab | Parent or Participant's Assessment of Global Activity (VAS) | Week 48 (n=6) | 11.7 mm | Standard Deviation 13.9 |
| Tocilizumab | Parent or Participant's Assessment of Global Activity (VAS) | Week 60 (n=6) | 10.2 mm | Standard Deviation 13.8 |
| Tocilizumab | Parent or Participant's Assessment of Global Activity (VAS) | Week 72 (n=2) | 3.5 mm | Standard Deviation 4.9 |
| Tocilizumab | Parent or Participant's Assessment of Global Activity (VAS) | Follow-Up (n=7) | 9.7 mm | Standard Deviation 16 |
Secondary
Parent or Participant's Assessment of Pain (VAS)
Parents or participants rated participant's pain by placing a horizontal line on a VAS of 0 (no pain)- 100 mm (severe pain).
Time frame: Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; n = number of participants analyzed at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Parent or Participant's Assessment of Pain (VAS) | Baseline (n=7) | 10.9 mm | Standard Deviation 21.8 |
| Tocilizumab | Parent or Participant's Assessment of Pain (VAS) | Week 12 (n=7) | 7.0 mm | Standard Deviation 10 |
| Tocilizumab | Parent or Participant's Assessment of Pain (VAS) | Week 24 (n=7) | 13.7 mm | Standard Deviation 16.7 |
| Tocilizumab | Parent or Participant's Assessment of Pain (VAS) | Week 28 (n=1) | 1.0 mm | Standard Deviation 0 |
| Tocilizumab | Parent or Participant's Assessment of Pain (VAS) | Week 32 (n=2) | 28.5 mm | Standard Deviation 17.7 |
| Tocilizumab | Parent or Participant's Assessment of Pain (VAS) | Week 36 (n=7) | 10.6 mm | Standard Deviation 15.9 |
| Tocilizumab | Parent or Participant's Assessment of Pain (VAS) | Week 48 (n=6) | 12.3 mm | Standard Deviation 13.6 |
| Tocilizumab | Parent or Participant's Assessment of Pain (VAS) | Week 60 (n=6) | 10.2 mm | Standard Deviation 13.8 |
| Tocilizumab | Parent or Participant's Assessment of Pain (VAS) | Week 72 (n=2) | 4.0 mm | Standard Deviation 5.7 |
| Tocilizumab | Parent or Participant's Assessment of Pain (VAS) | Follow-Up (n=7) | 9.9 mm | Standard Deviation 15.9 |
Secondary
Percentage of Participants Achieving Clinical Remission (CR) at Each Visit
CR was defined as clinical remission with medication (CRem). A participant was in CR if inactive disease was observed for a minimum of 6 consecutive months.
Time frame: Baseline, Screening, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Baseline (n=7) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 16 (n=7) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 20 (n=7) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 24 (n=7) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 28 (n=7) | 14.3 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 32 (n=7) | 14.3 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 56 (n=6) | 16.7 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 60 (n=6) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 64 (n=5) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Screening (n=7) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 4 (n=7) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 8 (n=7) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 12 (n=7) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 36 (n=7) | 14.3 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 40 (n=6) | 16.7 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 44 (n=6) | 16.7 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 48 (n=6) | 16.7 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 52 (n=6) | 16.7 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 68 (n=3) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 72 (n=2) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Week 76 (n=1) | 0.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Clinical Remission (CR) at Each Visit | Follow-Up (n=7) | 0.0 percentage of participants |
Secondary
Percentage of Participants With Inactive Disease by Visit
A participant was defined to show inactive disease if all of the following criteria were applied: 1) No joints with active arthritis (no joints with swelling and no joints with lack of motion), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) Physician's global assessment of disease activity equals (=) 0 millimeters (mm) on a Visual analog scale (VAS).
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Percentage of Participants With Inactive Disease by Visit | Week 12 (n=7) | 42.9 percentage of participants |
| Tocilizumab | Percentage of Participants With Inactive Disease by Visit | Week 24 (n=7) | 14.3 percentage of participants |
| Tocilizumab | Percentage of Participants With Inactive Disease by Visit | Week 36 (n=7) | 42.9 percentage of participants |
| Tocilizumab | Percentage of Participants With Inactive Disease by Visit | Week 48 (n=6) | 16.7 percentage of participants |
| Tocilizumab | Percentage of Participants With Inactive Disease by Visit | Week 60 (n=6) | 33.3 percentage of participants |
| Tocilizumab | Percentage of Participants With Inactive Disease by Visit | Week 72 (n=2) | 50.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Inactive Disease by Visit | Follow-Up (n=7) | 57.1 percentage of participants |
| Tocilizumab | Percentage of Participants With Inactive Disease by Visit | Baseline(n=7) | 57.1 percentage of participants |
Secondary
Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit
The six JIA ACR components comprised of: 1) Physician's global assessment of disease activity, 2) Parent/Participant's global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP), and 6) Childhood Health Assessment Questionnaire - Disease Index (CHAQ-DI). At an assessment visit, a JIA ACR30/50/70/90 response in comparison to Baseline was defined as: At least three of the six JIA ACR core components improving by at least 30 percent (%), 50%, 70%, or 90% respectively and no more than one of the remaining JIA ACR core components worsening by more than 30%.
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; number (n) = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Baseline JIA ACR30 (n=7) | 85.7 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 12 JIA ACR30 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 24 JIA ACR30 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 36 JIA ACR30 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 48 JIA ACR30 (n=6) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 60 JIA ACR30 (n=6) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 72 JIA ACR30 (n=2) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Follow-Up JIA ACR30 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 72 JIA ACR50 (n=2) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Follow-Up JIA ACR50 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Baseline JIA ACR70 (n=6) | 85.7 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 12 JIA ACR70 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 24 JIA ACR70 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 48 JIA ACR70 (n=6) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 60 JIA ACR70 (n=6) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Follow-Up JIA ACR70 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Baseline JIA ACR90 (n=6) | 85.7 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 12 JIA ACR90 (n=7) | 85.7 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 24 JIA ACR90 (n=7) | 57.1 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 36 JIA ACR90 (n=7) | 71.4 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 48 JIA ACR90 (n=6) | 83.3 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 60 JIA ACR90 (n=6) | 66.7 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Follow-Up JIA ACR90 (n=7) | 85.7 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Baseline JIA ACR50 (n=7) | 85.7 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 12 JIA ACR50 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 24 JIA ACR50 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 36 JIA ACR50 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 48 JIA ACR50 (n=6) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 60 JIA ACR50 (n=6) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 36 JIA ACR70 (n=7) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 72 JIA ACR70 (n=2) | 100.0 percentage of participants |
| Tocilizumab | Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit | Week 72 JIA ACR90 (n=2) | 100.0 percentage of participants |
Secondary
Physicians Assessment of Global Activity (VAS)
The participant's treating physician provided a rating of the participant's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line, score 0 represented 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end score 100 represented 'arthritis very active'. A higher score indicated more disease activity.
Time frame: Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Population: Safety Analysis Set; n = number of participants analyzed at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Physicians Assessment of Global Activity (VAS) | Baseline (n=7) | 12.0 mm | Standard Deviation 30.4 |
| Tocilizumab | Physicians Assessment of Global Activity (VAS) | Week 12 (n=7) | 2.3 mm | Standard Deviation 2.9 |
| Tocilizumab | Physicians Assessment of Global Activity (VAS) | Week 24 (n=7) | 5.4 mm | Standard Deviation 6.1 |
| Tocilizumab | Physicians Assessment of Global Activity (VAS) | Week 28 (n=1) | 1.0 mm | Standard Deviation 0 |
| Tocilizumab | Physicians Assessment of Global Activity (VAS) | Week 32 (n=2) | 29.0 mm | Standard Deviation 8.5 |
| Tocilizumab | Physicians Assessment of Global Activity (VAS) | Week 36 (n=7) | 5.0 mm | Standard Deviation 7.9 |
| Tocilizumab | Physicians Assessment of Global Activity (VAS) | Week 48 (n=6) | 5.7 mm | Standard Deviation 8.2 |
| Tocilizumab | Physicians Assessment of Global Activity (VAS) | Week 60 (n=6) | 5.7 mm | Standard Deviation 8.7 |
| Tocilizumab | Physicians Assessment of Global Activity (VAS) | Week 72 (n=2) | 1.0 mm | Standard Deviation 1.4 |
| Tocilizumab | Physicians Assessment of Global Activity (VAS) | Follow-Up (n=7) | 5.0 mm | Standard Deviation 8.7 |