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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018331-18 |
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This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab) on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients with active rheumatoid arthritis who have an inadequate response to current biologic or non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as monotherapy or in combination with their current non-biologic DMARD. Anticipated time on study treatment is 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8 mg/kg iv every 4 weeks, 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis | Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of fluorescein isothiocyanate (FITC)-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hours (hrs) and 20 hrs stimulated and control samples were analyzed for levels of apoptosis. | Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) |
| Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) | Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of FITC-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hrs and 20 hrs stimulated and control samples were analyzed for levels of apoptosis. GM-CSF is an agent that delays apoptosis. Percentage of cells that stained positive for Annexin V binding in the presence or absence of GM-CSF (GM-CSF delayed or constitutive) were determined by flow cytometry. | Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) |
| Mean Fluorescence Intensity of CD11b on Neutrophil Surface | Neutrophils were incubated with labeled antibodies against CD11b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles. | Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) |
| Mean Fluorescence Intensity of CD18 on Neutrophil Surface | Neutrophils were incubated with labeled antibodies against CD18. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score Based on 28-Joint Count (DAS28) | The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index includes swollen and tender joint counts, acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]), and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS, which includes a 44 swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher 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 |
|---|---|---|---|---|---|---|
| Liverpool | L9 7AL | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab 8 Milligrams Per Kilogram (mg/kg) | Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) intravenously (IV), once every 4 weeks up to 52 weeks (total of 13 infusions). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) |
| Mean Fluorescence Intensity of CD62L (L Selectin) on Neutrophil Surface | Neutrophils were incubated with labeled antibody against CD62L (L selectin). Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion of neutrophils to vessel walls. | Visits 2, 3 and 5 (Baseline and Weeks 4 and 12) |
| Mean Fluorescence Intensity of CD63 on Neutrophil Surface | Neutrophils were incubated with labeled antibody against CD63b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater azurophilic degranulation, an indicator of greater microbe killing. | Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) |
| Mean Fluorescence Intensity of Interleukin-6 Receptor (Il-6R) on Neutrophil Surface | Neutrophils were incubated with labeled antibody against IL-6R. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater density of membrane bound IL-6 receptor. | Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) |
| Mean Fluorescence Intensity of Membrane Bound Tumor Necrosis Factor Alpha (mTNFα) on Neutrophil Surface | Neutrophils were incubated with labeled antibody against mTNF. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates to a greater density of membrane bound TNF. | Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) |
| Mean Chemiluminescence (Area Under the Concentration-time Curve [AUC]) of Neutrophil Reactive Species Production Using Formyl-Methionyl-Leucyl-Phenylalanine (fMLP) Stimulation | Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). fMLP stimulation is mediated through the fMLP receptor on the cell surface. The fMLP response is only observed in primed neutrophils and response is a measure of in vivo priming. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC. | Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24) |
| Mean Chemiluminescence (AUC) of Neutrophil Reactive Species Production Using Phorbol 12-Myristate 13-Acetate (PMA) Stimulation | Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). PMA is a receptor-independent stimulator of the respiratory burst and the PMA response measures the total capacity of neutrophils to generate reactive oxidants. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC. | Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24) |
| Percentage of Neutrophils Positive for Propidium Iodide (PI)-Labeled Staphylococcus Aureus (S. Aureus) Uptake | S. aureus were heat killed then labeled with PI and opsonized with AB serum (SAPI). S. aureus was then incubated with the neutrophils for 30 minutes at 37 degrees Celsius. The neutrophils were washed, then the percentage of cells positive for the labeled S. aureus (that is, phagocytosed) was calculated via flow cytometry. A higher percentage represented more active phagocytosis. | Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) |
| Percentage of Neutrophils Positive for Dihydrorhodamine-123 (DHR) Oxidation | Phagocytosis can be measured by incubating neutrophils with PI-labeled heat killed S. aureus following incubation for 30 minutes. Neutrophils are co-incubated with DHR, which becomes oxidized by the products of the respiratory burst generated during phagocytosis. Fluorescence can then be measured by flow cytometry. | Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) |
| Screening, Baseline, and Weeks 4, 8, 12, 16, 20, 24, 36, 48, and 52 |
| Percentage of Participants With Acceptable and Not Acceptable Benefit-Risk Assessments | Benefit:Risk was defined at the participant level. It was considered acceptable if the DAS28 improvement represented at least a moderate European League Against Rheumatism (EULAR) response. The risks were based on the known adverse event (AE) profile of tocilizumab rather than on the actual AEs experienced by each participant | Weeks 12, 24, and 36 |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population: all participants who received at least 1 dose of tocilizumab treatment and had at least 1 post-baseline safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab 8 mg/kg | Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions). |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | 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 | Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis | Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of fluorescein isothiocyanate (FITC)-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hours (hrs) and 20 hrs stimulated and control samples were analyzed for levels of apoptosis. | Intent-to-treat (ITT) Population: all participants in the Safety Population who provided follow-up data for neutrophils or at least 1 efficacy variable. n (number) equals (=) number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | percentage of cells staining positive | Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) |
|
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| Primary | Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) | Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of FITC-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hrs and 20 hrs stimulated and control samples were analyzed for levels of apoptosis. GM-CSF is an agent that delays apoptosis. Percentage of cells that stained positive for Annexin V binding in the presence or absence of GM-CSF (GM-CSF delayed or constitutive) were determined by flow cytometry. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | percentage of cells staining positive | Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) |
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| Primary | Mean Fluorescence Intensity of CD11b on Neutrophil Surface | Neutrophils were incubated with labeled antibodies against CD11b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | fluorescence intensity unit | Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) |
|
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| Primary | Mean Fluorescence Intensity of CD18 on Neutrophil Surface | Neutrophils were incubated with labeled antibodies against CD18. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles. | ITT Population; n=number of participants analyzed at each visit | Posted | Mean | Standard Deviation | fluorescence intensity unit | Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) |
|
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| Primary | Mean Fluorescence Intensity of CD62L (L Selectin) on Neutrophil Surface | Neutrophils were incubated with labeled antibody against CD62L (L selectin). Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion of neutrophils to vessel walls. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | fluorescence intensity unit | Visits 2, 3 and 5 (Baseline and Weeks 4 and 12) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Fluorescence Intensity of CD63 on Neutrophil Surface | Neutrophils were incubated with labeled antibody against CD63b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater azurophilic degranulation, an indicator of greater microbe killing. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | fluorescence intensity unit | Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Fluorescence Intensity of Interleukin-6 Receptor (Il-6R) on Neutrophil Surface | Neutrophils were incubated with labeled antibody against IL-6R. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater density of membrane bound IL-6 receptor. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | fluorescence intensity unit | Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Fluorescence Intensity of Membrane Bound Tumor Necrosis Factor Alpha (mTNFα) on Neutrophil Surface | Neutrophils were incubated with labeled antibody against mTNF. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates to a greater density of membrane bound TNF. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | fluorescence intensity unit | Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Chemiluminescence (Area Under the Concentration-time Curve [AUC]) of Neutrophil Reactive Species Production Using Formyl-Methionyl-Leucyl-Phenylalanine (fMLP) Stimulation | Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). fMLP stimulation is mediated through the fMLP receptor on the cell surface. The fMLP response is only observed in primed neutrophils and response is a measure of in vivo priming. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | chemiluminescence units*hours | Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Chemiluminescence (AUC) of Neutrophil Reactive Species Production Using Phorbol 12-Myristate 13-Acetate (PMA) Stimulation | Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). PMA is a receptor-independent stimulator of the respiratory burst and the PMA response measures the total capacity of neutrophils to generate reactive oxidants. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | chemiluminescence units * hours | Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Neutrophils Positive for Propidium Iodide (PI)-Labeled Staphylococcus Aureus (S. Aureus) Uptake | S. aureus were heat killed then labeled with PI and opsonized with AB serum (SAPI). S. aureus was then incubated with the neutrophils for 30 minutes at 37 degrees Celsius. The neutrophils were washed, then the percentage of cells positive for the labeled S. aureus (that is, phagocytosed) was calculated via flow cytometry. A higher percentage represented more active phagocytosis. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | percentage of positive neutrophils | Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) |
|
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| Primary | Percentage of Neutrophils Positive for Dihydrorhodamine-123 (DHR) Oxidation | Phagocytosis can be measured by incubating neutrophils with PI-labeled heat killed S. aureus following incubation for 30 minutes. Neutrophils are co-incubated with DHR, which becomes oxidized by the products of the respiratory burst generated during phagocytosis. Fluorescence can then be measured by flow cytometry. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | percentage of positive neutrophils | Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Activity Score Based on 28-Joint Count (DAS28) | The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index includes swollen and tender joint counts, acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]), and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS, which includes a 44 swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | score on a scale | Screening, Baseline, and Weeks 4, 8, 12, 16, 20, 24, 36, 48, and 52 |
|
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| Secondary | Percentage of Participants With Acceptable and Not Acceptable Benefit-Risk Assessments | Benefit:Risk was defined at the participant level. It was considered acceptable if the DAS28 improvement represented at least a moderate European League Against Rheumatism (EULAR) response. The risks were based on the known adverse event (AE) profile of tocilizumab rather than on the actual AEs experienced by each participant | ITT Population; n=number of participants analyzed for the specified parameter at a given visit. | Posted | Number | percentage of participants | Weeks 12, 24, and 36 |
|
|
Adverse events were recorded from the date of Screening until the End of Study which was the follow up visit after 48 Weeks of extension treatment period.
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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 (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions). | 4 | 21 | 21 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment | After the third Tocilizumab administration was given patient had a neutrophil count of 0.39 x 109/L. No infection was reported. when the neutrophil count reached back to 2.16 x 109/L, the event was considered to have resolved without intervention. |
|
| Pneumonia Viral | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Joint lock | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (14.0) | Non-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- LaRoche | 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 |
|---|---|
|
| Visit 8, 4 hrs (n=15) |
|
| Visit 2, 20 hrs (n=19) |
|
| Visit 3, 20 hrs (n=19) |
|
| Visit 5, 20 hrs (n=19) |
|
| Visit 8, 20 hrs (n=15) |
|
| 0.415 |
| No |
| Superiority or Other |
| 4 hrs: Visit 5 versus Visit 3 | t-test, 2 sided | 0.335 | No | Superiority or Other |
| 4 hrs: Visit 8 versus Visit 2 | t-test, 2 sided | 0.120 | No | Superiority or Other |
| 4 hrs: Visit 8 versus Visit 3 | t-test, 2 sided | 0.061 | No | Superiority or Other |
| 4 hrs: Visit 8 versus Visit 5 | t-test, 2 sided | 0.031 | No | Superiority or Other |
| 20 hrs: Visit 3 versus Visit 2 | t-test, 2 sided | 0.131 | No | Superiority or Other |
| 20 hrs: Visit 5 versus Visit 2 | t-test, 2 sided | 0.202 | No | Superiority or Other |
| 20 hrs: Visit 5 versus Visit 3 | t-test, 2 sided | 0.484 | No | Superiority or Other |
| 20 hrs: Visit 8 versus Visit 2 | t-test, 2 sided | 0.047 | No | Superiority or Other |
| 20 hrs: Visit 8 versus Visit 3 | t-test, 2 sided | 0.285 | No | Superiority or Other |
| 20 hrs: Visit 8 versus Visit 5 | t-test, 2 sided | 0.315 | No | Superiority or Other |
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