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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006443-39 |
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This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion time for the first administration, followed by a 31 minute infusion time for subsequent administrations (unless drug-related infusion reactions occur).The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion | An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion. | Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE) | Weeks 4, 8, 12, 16, 20 and Final Visit | |
| Percentage of Participants Discontinuing Tocilizumab for Any Reason | Weeks 4, 8, 12, 16, 20 and Final Visit |
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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 |
|---|---|---|---|---|---|---|
| Vitoria-Gasteiz | Alava | 01009 | Spain | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab, 1 Hour Infusions | Participants received tocilizumab 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks). |
| FG001 | Tocilizumab, 31 Minute Infusions |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| tocilizumab [RoActemra/Actemra] | Drug | 8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration |
|
| Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | 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/hr]) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity; DAS28 less than (<) 2.6 = remission. A reduction of at least 1.2 units was considered a clinically significant difference. | Weeks 4, 8, 12, 16, 20 and Final Visit |
| Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr), and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. | Weeks 4, 8, 12, 16, 20 and Final Visit |
| Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. | Weeks 4, 8, 12, 16, 20 and Final Visit |
| DAS28 Score by Visit | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. Last observation carried forward (LOCF) visit took the last non-missing post-baseline available value. | Weeks 4, 8, 12, 16, 20, and Final Visit |
| Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | ACR20 response defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (ESR or C-Reactive Protein [CRP]) | Weeks 4, 8, 12, 16, 20 and Final Visit |
| Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | ACR50 response defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP). | Weeks 4, 8, 12, 16, 20 and Final Visit |
| Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | ACR70 response defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP). | Weeks 4, 8, 12, 16, 20 and Final Visit |
| Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | ACR90 response defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP). | Weeks 4, 8, 12, 16, 20 and Final Visit |
| C-Reactive Protein (CRP) Levels | CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis. CRP is measured in milligrams per liter (mg/L). | Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit |
| Erythrocyte Sedimentation Rate | ESR is an acute phase reactant measured in mm/hr. Reduction in ESR indicates improvement. | Baseline, Weeks 2, 4, 8, 12,16, 20, and 24 |
| HAQ-DI Score by Visit | HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. | Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24 |
| Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement. | Weeks 4, 8, 12, 16, 20 and Final Visit |
| Villajoyosa |
| Alicante |
| 03570 |
| Spain |
| Ávila | Avila | 05071 | Spain |
| Menorca | Balearic Islands | 07701 | Spain |
| Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Badalona | Barcelona | 08915 | Spain |
| L'Hospitalet de Llobregat | Barcelona | 08906 | Spain |
| Mollet del Vallès | Barcelona | 08100 | Spain |
| Torrelavega | Cantabria | 39300 | Spain |
| Castellon | Castellon | 12004 | Spain |
| Alcalá de Henares | Madrid | 28805 | Spain |
| Madrid | Madrid | 28031 | Spain |
| Madrid | Madrid | 28935 | Spain |
| San Sebastián de los Reyes | Madrid | 28702 | Spain |
| Vigo | Pontevedra | 36204 | Spain |
| Vigo | Pontevedra | 36214 | Spain |
| Gijón | Principality of Asturias | 33394 | Spain |
| Oviedo | Principality of Asturias | 33006 | Spain |
| Alzira | Valencia | 46600 | Spain |
| San Juan | Valencia | 03550 | Spain |
| Valenica | Valencia | 46009 | Spain |
| Galdakao | Vizcaya | 48960 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions. |
| COMPLETED |
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| NOT COMPLETED |
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|
Intent-to-treat (ITT) Population: all participants enrolled in the study who had been randomly assigned to one of the two study treatments and received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab, 1 Hour Infusions | Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks). |
| BG001 | Tocilizumab, 31 Minute Infusions | Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| |||||||||||||||
| 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 | Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion | An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion. | ITT Population | Posted | Number | percentage of participants | Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE) | ITT Population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20 and Final Visit |
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| Secondary | Percentage of Participants Discontinuing Tocilizumab for Any Reason | ITT Population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20 and Final Visit |
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| Secondary | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | 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/hr]) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity; DAS28 less than (<) 2.6 = remission. A reduction of at least 1.2 units was considered a clinically significant difference. | ITT Population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20 and Final Visit |
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| Secondary | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr), and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. | ITT Population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20 and Final Visit |
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| Secondary | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. | ITT population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20 and Final Visit |
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| Secondary | DAS28 Score by Visit | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. Last observation carried forward (LOCF) visit took the last non-missing post-baseline available value. | ITT Population; n (number)=number of participants analyzed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | units on a scale | Weeks 4, 8, 12, 16, 20, and Final Visit |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | ACR20 response defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (ESR or C-Reactive Protein [CRP]) | ITT Population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20 and Final Visit |
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| Secondary | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | ACR50 response defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP). | ITT Population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20 and Final Visit |
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| Secondary | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | ACR70 response defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP). | ITT Population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20 and Final Visit |
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| Secondary | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | ACR90 response defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP). | ITT Population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20 and Final Visit |
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| Secondary | C-Reactive Protein (CRP) Levels | CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis. CRP is measured in milligrams per liter (mg/L). | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | mg/L | Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit |
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| Secondary | Erythrocyte Sedimentation Rate | ESR is an acute phase reactant measured in mm/hr. Reduction in ESR indicates improvement. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | mm/hr | Baseline, Weeks 2, 4, 8, 12,16, 20, and 24 |
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| Secondary | HAQ-DI Score by Visit | HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. | ITT Population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24 |
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| Secondary | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement. | ITT Population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20 and Final Visit |
|
Adverse events were recorded from the date of Screening until the End of Study (24 Weeks)
Not provided
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, 1 Hour Infusions | Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks). | 2 | 37 | 30 | 37 | ||
| EG001 | Tocilizumab, 31 Minute Infusions | Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions. | 2 | 39 | 26 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspiration joint | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Transaminase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Aphonia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Dental implantation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | 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 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 |
Not provided
Not provided
Not provided
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