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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005516-29 | EudraCT Number |
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This open-label, single arm, multicenter long-term extension study will evaluate the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental | Tocilizumab 8 milligrams per kilogram (mg/kg) administered intravenously once every 4 weeks during a minimum of 104 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Tocilizumab 8 mg/kg administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Any Adverse Event (AE) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any AE that is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect in a neonate/infant or significant medical event in the Investigator's judgment. AE of special interest (AESI) includes serious and/or medically significant infectious; myocardial infarction(MI) / acute coronary syndrome (ACS); gastrointestinal (GI) perforation; anaphylaxis / hypersensitivity reactions; demyelinating disorders; stroke; serious and/or medically significant bleeding events; serious and/or medically significant hepatic events; malignancies malignant. | Up to 160 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Clinical Remission Period | Clinical remission: Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) less than (<)2.6 and/or Simplified Disease Activity Index (SDAI) less than or equal to (≤)3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient's global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0-10, with higher scores corresponding to greater disease activity. SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0-86, where lower scores indicate less disease activity. |
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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 |
|---|---|---|---|---|---|---|
| Cahors | 46005 | France | ||||
A total 15 participants who completed the Week 104 visit of the WA19926 core study, were enrolled in this follow-up open-label extension study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab | Tocilizumab 8 milligrams per kilogram (mg/kg) administered intravenously once every 4 weeks during a minimum of 104 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Up to approximately 148 weeks |
| Percentage of Participants With at Least One Drug-Free Period | Drug-free remission period was defined as clinical remission for at least 2 consecutive assessment visits (every 12 weeks) AND without tocilizumab administration during this clinical remission period. | Up to approximately 148 weeks |
| Cumulative Time of Remission Per Participant Over the Extension Study Period | Clinical remission was defined as DAS28-ESR <2.6 and/or SDAI ≤3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. SDAI scores range from 0 to 86, where lower scores indicate less disease activity. | Up to approximately 148 weeks |
| Percentage of Participants With at Least 1 Rheumatoid Arthritis (RA) Flare | An RA flare was defined as an increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. | Up to approximately 148 weeks |
| Time to RA Flare Following Remission or Drug-Free Remission | Time to RA flare was defined as period of clinical remission or drug-free remission followed by flare of DAS28-ESR (increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2). In the case of several remission periods for the same participant, the largest period was used. | Up to approximately 148 weeks |
| Change From Day 1 in DAS28-ESR Scores Over Time | DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient's global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
| Change From Day 1 in Simplified Disease Activity Index (SDAI) Scores Over Time | SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
| Change From Day 1 in Tender Joint Count Based on 28 Joints (TJC28) Over Time | The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 tender joints. Higher scores correspond to greater disease activity. | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
| Change From Day 1 in Swollen Joint Count Based on 28 Joints (SJC28) Over Time | The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 swollen joints. Higher scores correspond to greater disease activity. | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
| Erythrocyte Sedimentation Rate (ESR) Over Time | ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. Higher scores correspond to greater disease activity. | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
| C-reactive Protein (CRP) Level | C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5 milligrams per liter (mg/L). Higher scores correspond to greater disease activity. | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
| Participants' Global Assessment of Pain (VAS) Score | The participants' global assessment of pain (VAS) was assessed using a 100-mm horizontal VAS with 0=no pain to 100=maximum pain. | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
| Participants' Global Assessment of Disease Activity (VAS) Score | The participants' global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease. | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
| Physicians' Global Assessment of Disease Activity (VAS) Score | The physicians' global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease. | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
| Percentage of Participants With Health Assessment Questionnaire Disability Index (HAQ-DI) Remission | HAQ-DI remission was defined as HAQ-DI score <0.5. HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. | Baseline and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128 140 |
| Percentage of Participants With Clinically Meaningful Improvement From Baseline in HAQ-DI | Clinically meaningful improvement was defined as an improvement in HAQ-DI score of ≥0.22. HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. | Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
| Montpellier |
| 34295 |
| France |
| Mulhouse | 68070 | France |
| Orléans | 45032 | France |
| Paris | 75651 | France |
| Toulouse | 31059 | France |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis was performed in Included population, defined as all participants who entered the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab | Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
|
| 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 | Percentage of Participants With Any Adverse Event (AE) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any AE that is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect in a neonate/infant or significant medical event in the Investigator's judgment. AE of special interest (AESI) includes serious and/or medically significant infectious; myocardial infarction(MI) / acute coronary syndrome (ACS); gastrointestinal (GI) perforation; anaphylaxis / hypersensitivity reactions; demyelinating disorders; stroke; serious and/or medically significant bleeding events; serious and/or medically significant hepatic events; malignancies malignant. | Safety population is defined as all included participants who received having at least one tocilizumab administration. | Posted | Number | percentage of participants | Up to 160 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Clinical Remission Period | Clinical remission: Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) less than (<)2.6 and/or Simplified Disease Activity Index (SDAI) less than or equal to (≤)3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient's global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0-10, with higher scores corresponding to greater disease activity. SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0-86, where lower scores indicate less disease activity. | The included population includes all participants who entered the study. All included participants were part of safety population. | Posted | Number | percentage of participants | Up to approximately 148 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Drug-Free Period | Drug-free remission period was defined as clinical remission for at least 2 consecutive assessment visits (every 12 weeks) AND without tocilizumab administration during this clinical remission period. | The included population includes all participants who entered the study. All included participants were part of safety population. | Posted | Number | percentage of participants | Up to approximately 148 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Time of Remission Per Participant Over the Extension Study Period | Clinical remission was defined as DAS28-ESR <2.6 and/or SDAI ≤3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. SDAI scores range from 0 to 86, where lower scores indicate less disease activity. | The included population includes all participants who entered the study. All included participants were part of safety population. | Posted | Median | Full Range | days | Up to approximately 148 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least 1 Rheumatoid Arthritis (RA) Flare | An RA flare was defined as an increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. | The included population includes all participants who entered the study. All included participants were part of safety population. | Posted | Number | percentage of participants | Up to approximately 148 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to RA Flare Following Remission or Drug-Free Remission | Time to RA flare was defined as period of clinical remission or drug-free remission followed by flare of DAS28-ESR (increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2). In the case of several remission periods for the same participant, the largest period was used. | The included population includes all participants who entered the study. All included participants were part of safety population. | Posted | Median | Full Range | days | Up to approximately 148 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Day 1 in DAS28-ESR Scores Over Time | DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient's global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
|
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| Secondary | Change From Day 1 in Simplified Disease Activity Index (SDAI) Scores Over Time | SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
|
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| Secondary | Change From Day 1 in Tender Joint Count Based on 28 Joints (TJC28) Over Time | The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 tender joints. Higher scores correspond to greater disease activity. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Mean | Standard Deviation | tender joints | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
|
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| Secondary | Change From Day 1 in Swollen Joint Count Based on 28 Joints (SJC28) Over Time | The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 swollen joints. Higher scores correspond to greater disease activity. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Mean | Standard Deviation | swollen joints | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
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| Secondary | Erythrocyte Sedimentation Rate (ESR) Over Time | ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. Higher scores correspond to greater disease activity. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Median | Full Range | mm/hour | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
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| Secondary | C-reactive Protein (CRP) Level | C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5 milligrams per liter (mg/L). Higher scores correspond to greater disease activity. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Median | Full Range | mg/L | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
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| Secondary | Participants' Global Assessment of Pain (VAS) Score | The participants' global assessment of pain (VAS) was assessed using a 100-mm horizontal VAS with 0=no pain to 100=maximum pain. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Median | Full Range | units on a scale | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
|
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| Secondary | Participants' Global Assessment of Disease Activity (VAS) Score | The participants' global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Median | Full Range | units on a scale | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
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| Secondary | Physicians' Global Assessment of Disease Activity (VAS) Score | The physicians' global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Median | Full Range | units on a scale | Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
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| Secondary | Percentage of Participants With Health Assessment Questionnaire Disability Index (HAQ-DI) Remission | HAQ-DI remission was defined as HAQ-DI score <0.5. HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Number | percentage of participants | Baseline and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128 140 |
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| Secondary | Percentage of Participants With Clinically Meaningful Improvement From Baseline in HAQ-DI | Clinically meaningful improvement was defined as an improvement in HAQ-DI score of ≥0.22. HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. | The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points. | Posted | Number | percentage of participants | Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140 |
|
|
Up to 160 weeks
An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Safety population, defined as all included participants having at least one tocilizumab administration.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tocilizumab | Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks. | 1 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Metatarsalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Inflammatory pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Colonoscopy | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Interferon gamma release assay positive | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Tooth avulsion | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
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| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
| |
| Dental cleaning | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
| |
| Eye laser surgery | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
| |
| Joint injection | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
| |
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Radicular pain | Nervous system disorders | MedDRA (16.0) | 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| 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
| Title | Measurements |
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| Tocilizumab-related AE |
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| Tocilizumab-related SAE |
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| Tocilizumab-related non-SAE |
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| AESI |
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| Tocilizumab-related AESI |
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| AE leading to dose modification |
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| AE leading to Tocilizumab discontinuation |
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| AE leading to death |
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| Participants |
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