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This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8 mg/kg iv every 4 weeks for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Health Assessment Questionnaire (HAQ) Score | HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study. | Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit |
| Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment | HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. | Weeks 4, 8, 12, 16, 20, and 24 |
| Change in HAQ Score at Week 24 | HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score as Assessed by Visual Analogue Scale (VAS) | Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain. | Weeks 0, 4, 8, 12, 16, 20, and 24 |
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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 |
|---|---|---|---|---|---|---|
| Chelyabinsk Regional Clinical Hospital; Rheumatology | Chelyabinsk | 454076 | Russia | |||
| Republican clinical hospital of Karachai-Cherkess; Rheumatologic Department |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab | Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (but not more than 800 mg), intravenously (IV), every 4 weeks for 24 weeks. Participants received a total of 6 infusions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| DMARDs (disease-modifying antirheumatic drugs) |
| Drug |
stable doses at investigator's prescription |
|
| European Quality of Life - 5 Dimensions (EQ-5D) Score |
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Weeks 0, 4, 8, 12, 16, 20, and 24 |
| Change in EQ-5D Score at Week 24 From Baseline | EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D <0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect. | Baseline and Week 24 |
| General Health Score as Assessed by EQ-5D VAS | Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. | Weeks 0, 4, 8, 12, 16, 20, and 24 |
| Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D | Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase. | Weeks 0, 4, 8, 12, 16, 20, and 24 |
| Change in General Health Assessed by VAS | Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. | Baseline and Week 24 |
| Disease Activity Score Based on 28-Joint Count (DAS28) | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. | Weeks 0, 4, 8, 12, 16, 20, and 24 |
| Change in DAS28 Score From Baseline to Week 24 | Baseline and Week 24 |
| Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than [<] 2.6), I=low (DAS28 less than or equal to [≤]2.6 to <3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than [>]5.1). | Weeks 0, 4, 8, 12, 16, 20, and 24 |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response | ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR. | Weeks 0, 4, 8, 12, 16, 20, and 24 |
| Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline >1.2 with DAS28 score ≤3.2; moderate effect: change from baseline >1.2 with DAS28 score 3.2 to 5.1 or change from baseline >0.6 to <1.2 with DAS28 score <3.2; no effect: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 score >5.1. | Weeks 4, 8, 12, 16, 20, and 24 |
| C-Reactive Protein | CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein. | Weeks 4, 8, 12, 16, 20, and 24 |
| Erythrocyte Sedimentation Rate | ESR (mm/hr) is used to determine the acute phase response. | Weeks 4, 8, 12, 16, 20, and 24 |
| Cherkess |
| 369000 |
| Russia |
| Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise | Irkutsk | 664047 | Russia |
| Republican Clinicodiagnostic Center | Izhevsk | 426009 | Russia |
| Kaliningrad Regional Clinical Hospital; Rheumatologic Department | Kaliningrad | 236016 | Russia |
| War Veterans Regional Clinical Hospital;Therapy Department | Kemerovo | 650099 | Russia |
| Kirov Regional Clinical Hospital; Reumatology Department | Kirov | 610028 | Russia |
| GUZ Regional clinical hospital # 1 | Krasnodar | 350086 | Russia |
| GMU Kursk regional clinical hospital | Kursk | 305007 | Russia |
| FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences | Moscow | 115522 | Russia |
| FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA" | Moscow | 115682 | Russia |
| FGU Central Clinical Hospital with Polyclinic Administration President RF | Moscow | 121359 | Russia |
| Head Clinical Hospital of Internal Affair Ministry of Russia | Moscow | 123060 | Russia |
| Vladimirskiy Regional Scientific Research Inst. | Moscow | 129110 | Russia |
| SIH Nizhny Novgorod Regional Clinical Hospital n.a. Semashko | Nizhny Novgorod | 603126 | Russia |
| Republican Hospital Named After V.A. Baranov | Petrozavodsk | 185019 | Russia |
| Rostov State Medical University; Cardiorheumatology Department | Rostov-on-Don | 344022 | Russia |
| Clinical hospital #1 | Smolensk | 214001 | Russia |
| Surgut Region Clinical Hospital | Surgut | 628408 | Russia |
| Glpu Tjumen Regional Clinical Hospital #1 | Tyumen | 625023 | Russia |
| Republican clinical hospital named after G.G. Kuvatov | Ufa | 450005 | Russia |
| State Institution of Healthcare Ulyanovsk Regional Clinical Hospital | Ulyanovsk | 432063 | Russia |
| GUZ "Novgorod Regional Clinical Hospital"; Cardioreumatological | Veliky Novgorod | 173008 | Russia |
| Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1" | Voronezh | 394066 | Russia |
| Voronezh Regional Clinical Hospital #1 | Voronezh | 394066 | Russia |
| SHI Yaroslavl Regional Clinical Hospital | Yaroslavl | 150062 | Russia |
| Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40" | Yekaterinburg | 620102 | Russia |
| Sverdlovsk Regional Clinical Hospital # 1; Rheumatology Dept | Yekaterinburg | 620102 | Russia |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: All patients who received at least one dose and had at least one safety assessment after the drug administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab | Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 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 |
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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 | Health Assessment Questionnaire (HAQ) Score | HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study. | Intent-to-Treat (ITT) population: All participants randomized in the study who received administration of at least one dose of the study drug and who had at least one efficacy assessment performed. n (number) = number of participants assessed at a specific visit. | Posted | Mean | Standard Deviation | units on a scale | Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit |
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| |||||||||||||||||||||||||||||||||||
| Secondary | Pain Score as Assessed by Visual Analogue Scale (VAS) | Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain. | ITT Population; n=number of participants assessed at a specific visit. | Posted | Mean | Standard Deviation | mm | Weeks 0, 4, 8, 12, 16, 20, and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | European Quality of Life - 5 Dimensions (EQ-5D) Score | EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | ITT Population; n=number of participants assessed at a specific visit. | Posted | Mean | Standard Deviation | units on a scale | Weeks 0, 4, 8, 12, 16, 20, and 24 |
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| Secondary | Change in EQ-5D Score at Week 24 From Baseline | EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D <0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect. | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
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| Secondary | General Health Score as Assessed by EQ-5D VAS | Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. | ITT Population; n=number of participants assessed at a specific visit. | Posted | Mean | Standard Deviation | mm | Weeks 0, 4, 8, 12, 16, 20, and 24 |
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| Secondary | Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D | Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase. | ITT Population; n=number of participants assessed at a specific visit. | Posted | Number | percentage of Participants | Weeks 0, 4, 8, 12, 16, 20, and 24 |
|
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| Secondary | Change in General Health Assessed by VAS | Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. | ITT Population | Posted | Mean | Standard Deviation | mm | Baseline and Week 24 |
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| Secondary | Disease Activity Score Based on 28-Joint Count (DAS28) | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. | ITT Population; n=number of participants assessed at a specific visit. | Posted | Mean | Standard Deviation | units on a scale | Weeks 0, 4, 8, 12, 16, 20, and 24 |
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| Secondary | Change in DAS28 Score From Baseline to Week 24 | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
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| Primary | Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment | HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. | ITT population: | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20, and 24 |
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| Primary | Change in HAQ Score at Week 24 | HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. | ITT population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
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| Secondary | Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than [<] 2.6), I=low (DAS28 less than or equal to [≤]2.6 to <3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than [>]5.1). | ITT Population; n=number of participants assessed at a specific visit. | Posted | Number | percentage of participants | Weeks 0, 4, 8, 12, 16, 20, and 24 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response | ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR. | ITT Population; n=number of participants assessed at a specific visit. | Posted | Number | percentage of participants | Weeks 0, 4, 8, 12, 16, 20, and 24 |
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| Secondary | Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline >1.2 with DAS28 score ≤3.2; moderate effect: change from baseline >1.2 with DAS28 score 3.2 to 5.1 or change from baseline >0.6 to <1.2 with DAS28 score <3.2; no effect: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 score >5.1. | ITT Population; n=number of participants assessed at a specific visit. | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | C-Reactive Protein | CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein. | ITT Population; n=number of participants assessed at a specific visit. | Posted | Mean | Standard Deviation | mg/L | Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Erythrocyte Sedimentation Rate | ESR (mm/hr) is used to determine the acute phase response. | ITT Population; n=number of participants assessed at a specific visit. | Posted | Mean | Standard Deviation | mm/hr | Weeks 4, 8, 12, 16, 20, and 24 |
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From baseline Visit up to 24 weeks or until withdrawal
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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 | Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions. | 12 | 201 | 46 | 201 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erysipelatous inflammation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cervical myelopathy | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Localized infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Acute pyelonephritis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hemorrhagic anemia | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Toxic hepatitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chronic bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphostasis | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pyelonephritis chronic | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Skin reactions | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | 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 after the first publication or presentation that involves the overall study. 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 |
| D018501 | Antirheumatic Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| Title | Measurements |
|---|---|
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| Week 12 (n=196) |
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| Week 16 (n=193) |
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| Week 20 (n=193) |
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| Week 24 (n=193) |
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| Withdrawal visit (n=6) |
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| Categories |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 0 (n=200) |
| |||||
| Week 4 (n=198) |
| |||||
| Week 8 (n=194) |
| |||||
| Week 12 (n=196) |
| |||||
| Week 16 (n=191) |
| |||||
| Week 20 (n=193) |
| |||||
| Week 24 (n=189) |
| |||||
| Withdrawal visit (n=6) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 0 (n=201) |
| |||||
| Week 4 (n=198) |
| |||||
| Week 8 (n=197) |
| |||||
| Week 12 (n=193) |
| |||||
| Week 16 (n=193) |
| |||||
| Week 20 (n=193) |
| |||||
| Week 24 (n=193) |
| |||||
| Withdrawal visit (n=6) |
|