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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001097-25 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RoActemra/Actemra | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8 mg/kg iv every 4 weeks, 104 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks) |
| 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. | Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bremen | 28177 | Germany | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab 8 mg/kg | Participants received tocilizumab 8 mg/kg intravenously (IV) every 4 weeks up to 104 weeks or until tocilizumab was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
| 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). | Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
| 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. | 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) |
| 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. | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
| 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. | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
| 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. | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
| 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. | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
| 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. | 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) |
| 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). | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks) |
| 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). | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks) |
| CRP Levels | CRP an acute phase protein, is a marker of inflammation. CRP was measured as milligrams per deciliter (mg/dL). | 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) |
| Frankfurt am Main |
| 60316 |
| Germany |
| Sankt Augustin | 53757 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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All participants who received at least one dose of study drug were included in the Safety Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Safety Analysis Set | Posted | Number | participants | Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks) |
|
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| ||||||||||||||||||||||||||||||||||||
| 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%. | Safety Analysis Set; number (n) = number of participants analyzed for the given parameter at the specified visit. | Posted | Number | percentage of participants | Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | Safety Analysis Set | Posted | Number | adverse events | Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| 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). | Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit. | Posted | Number | percentage of participants | Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
|
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| 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. | Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit. | Posted | Number | percentage of participants | 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) |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | Safety Analysis Set; n = number of participants analyzed at the specified visit. | Posted | Mean | Standard Deviation | mm | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
|
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| 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. | Safety Analysis Set; n = number of participants analyzed at the specified visit. | Posted | Mean | Standard Deviation | mm | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
|
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| 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. | Safety Analysis Set; n = number of participants analyzed at the specified visit. | Posted | Mean | Standard Deviation | joints | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
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| 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. | Safety Analysis Set; n = number of participants analyzed at the specified visit. | Posted | Mean | Standard Deviation | joints | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks) |
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| 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. | Safety Analysis Set; n = number of participants analyzed at the specified visit. | Posted | Mean | Standard Deviation | mm/h | 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) |
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| 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). | Safety Analysis Set; n = number of participants analyzed at the specified visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks) |
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| 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). | Safety Analysis Set; n = number of participants analyzed at the specified visit. | Posted | Mean | Standard Deviation | mm | Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks) |
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| Secondary | CRP Levels | CRP an acute phase protein, is a marker of inflammation. CRP was measured as milligrams per deciliter (mg/dL). | Safety Analysis Set; n = number of participants analyzed at the specified visit. | Posted | Mean | Standard Deviation | mg/dL | 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) |
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Adverse events were collected from the date of screening until the final Follow-Up Visit (up to 82 weeks).
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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 | 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. | 1 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Aortic valve incompetence | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Local swelling | General disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Vaccination site reaction | General disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Acute tonsillitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Lice infestation | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Scarlet fever | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
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| Biopsy kidney | Investigations | MedDRA (16.0) | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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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-LaRoche or Genentech, Inc | 800-821-8590 | genentech@druginfo.com |
| 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 |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Title | Measurements |
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| Drug-related AEs of special interest |
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