Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01007435) will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental | Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) every 4 weeks for up to 104 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. An SAE can be a) fatal, b) life-threatening, c) requires/prolongs hospitalization, d) results in persistent/significant incapacity/disability, e) results in congenital anomaly/birth defect or f) is considered as a significant medical event by the investigator. | Baseline up to approximately 104 weeks |
| Percentage of Participants With TEAEs of Special Interest | An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. Nine categories of AE of special interest are identified for tocilizumab which includes a) serious/medically significant infections, b) myocardial infarction/acute coronary syndrome, c) gastrointestinal perforations, d) malignancies, e) anaphylaxis/hypersensitivity reactions, f) demyelinating disorders, g) stroke, h) serious and/or medically significant bleeding events, and i) serious/medically significant hepatic events. Data reported is an average of the nine categories. | Baseline up to approximately 104 weeks |
| Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation | An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. | Baseline up to approximately 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points | The DAS28-ESR is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) (patient global assessment of disease activity [PGA] using visual analog scale [VAS], range 1-100 millimeters [mm]) (higher scores indicate higher disease activity). DAS28-ESR is calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm [ln] ESR in mm/h) + (0.014*GH in mm VAS). DAS28-ESR scale is transformed and ranges from 0 to 10. A negative CFB indicated improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIP - Centro Internacional de Pesquisa | Goiânia | Goiás | 74110-120 | Brazil | ||
| Centro Mineiro de Pesquisa - CMIP |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab | Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) every 4 weeks for up to 104 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
| CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points | The SDAI is a combined index for measuring disease activity. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), physician global assessment (PhGA) and PGA of disease activity, both scored 0 to 10 centimeters (cm) as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal is less than (<) 1 mg/dL. SDAI is calculated according to the following formula: SDAI = TJC + SJC + PhGA + PGA + CRP. SDAI ranges from 0 to 86. A negative CFB indicated improvement. | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
| CFB in Swollen Joint Count (SJC) at Specified Time Points | For SJC, a total of 66 joints are assessed. The presence of a swollen joint is scored as 1 and absence as 0. Total score is calculated by adding the scores, which ranges from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicated no swollen joint and higher scores indicated worsening swollen joints. | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
| CFB in Tender Joint Count (TJC) at Specified Time Points | The number of tender joints is recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68. | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
| Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment Was Discontinued | Remission: DAS28-ESR score <2.6 and SDAI score </=3.3. DAS28-ESR index included SJC and TJC, both scored 0-28, as well as APR determined as ESR in mm/hr, and GH (ranges 1-100 mm; higher scores=higher disease activity). DAS28=(0.56*√TJC)+(0.28*√SJC) +(0.70*ln ESR) +(0.014*GH). DAS28-ESR scale is transformed and ranges from 0 to 10. Negative CFB indicated improvement. DAS28 >2.6 (clinical remission); DAS28 2.6 to 3.2 (low disease activity); DAS28 >3.2 to 5.1 = moderate to high disease activity. SDAI is sum of TJC and SJC (both scored 0-28), PhGA and PGA of disease activity (both scored 0 to 10 cm as assessed by VAS, higher scores=higher disease activity), and CRP in mg/dL where normal is <1 mg/dL. SDAI=TJC + SJC + PhGA + PGA + CRP. SDAI ranged from 0 to 86. A negative CFB indicated improvement. SDAI <=3.3 (clinical remission), >3.4 to 11 (low disease activity) >11 to 26 (moderate disease activity), and >26 = (high/severe disease activity). | Baseline up to approximately 104 weeks |
| Time to RA Crisis Among Participants Who Discontinued After Clinical Remission | RA crisis is any worsening of participant disease acitivity that, in the opinion of the investigator, required intensified treatment other than supportive therapy, and may have included restart of the treatment with the study drug. Time to RA crisis is defined as the period of remission without drug until the RA crisis documentation. | Baseline up to approximately 104 weeks |
| CFB in PGA of Disease Activity Using VAS Score at Specified Time Points | PGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative CFB indicated improvement. | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
| CFB in PGA of Pain Using VAS Score at Specified Time Points | PGA of pain is assessed on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm, and is described as "unbearable pain". A negative change indicated improvement. | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
| CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points | PhGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
| CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points | HAQ-DI is a self-reported participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Total score for HAQ-DI is the sum of all questions and ranges from 0 = without any difficulty to 60 = unable to do. A negative CFB indicates improvement. | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
| Juiz de Fora |
| Minas Gerais |
| 36036-330 |
| Brazil |
| Centro de Estudos em Terapias Inovadoras - CETI | Curtiba | Paraná | 80030-110 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Universidade Federal de Sao Paulo - UNIFESP; Reumatologia | São Paulo | São Paulo | 04026-000 | Brazil |
| Centro Paulista de Investigacao Clinica - CEPIC | São Paulo | São Paulo | 04266-010 | Brazil |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat (ITT) population included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab | Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| 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 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. An SAE can be a) fatal, b) life-threatening, c) requires/prolongs hospitalization, d) results in persistent/significant incapacity/disability, e) results in congenital anomaly/birth defect or f) is considered as a significant medical event by the investigator. | ITT population | Posted | Number | percentage of participants | Baseline up to approximately 104 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With TEAEs of Special Interest | An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. Nine categories of AE of special interest are identified for tocilizumab which includes a) serious/medically significant infections, b) myocardial infarction/acute coronary syndrome, c) gastrointestinal perforations, d) malignancies, e) anaphylaxis/hypersensitivity reactions, f) demyelinating disorders, g) stroke, h) serious and/or medically significant bleeding events, and i) serious/medically significant hepatic events. Data reported is an average of the nine categories. | ITT population | Posted | Number | percentage of participants | Baseline up to approximately 104 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation | An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. | ITT population | Posted | Number | percentage of participants | Baseline up to approximately 104 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points | The DAS28-ESR is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) (patient global assessment of disease activity [PGA] using visual analog scale [VAS], range 1-100 millimeters [mm]) (higher scores indicate higher disease activity). DAS28-ESR is calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm [ln] ESR in mm/h) + (0.014*GH in mm VAS). DAS28-ESR scale is transformed and ranges from 0 to 10. A negative CFB indicated improvement. | ITT population. Here, 'n' represents the number of participants available for assessment at a given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
| ||||||||||||||||||||||||||||||||||
| Secondary | CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points | The SDAI is a combined index for measuring disease activity. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), physician global assessment (PhGA) and PGA of disease activity, both scored 0 to 10 centimeters (cm) as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal is less than (<) 1 mg/dL. SDAI is calculated according to the following formula: SDAI = TJC + SJC + PhGA + PGA + CRP. SDAI ranges from 0 to 86. A negative CFB indicated improvement. | ITT population. Here, 'n' represents the number of participants available for assessment at a given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | CFB in Swollen Joint Count (SJC) at Specified Time Points | For SJC, a total of 66 joints are assessed. The presence of a swollen joint is scored as 1 and absence as 0. Total score is calculated by adding the scores, which ranges from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicated no swollen joint and higher scores indicated worsening swollen joints. | ITT population. Here, 'n' represents the number of participants available for assessment at a given time point. | Posted | Mean | Standard Deviation | swollen joints | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | CFB in Tender Joint Count (TJC) at Specified Time Points | The number of tender joints is recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68. | ITT population. Here, 'n' represents the number of participants available for assessment at a given time point. | Posted | Mean | Standard Deviation | tender joints | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment Was Discontinued | Remission: DAS28-ESR score <2.6 and SDAI score </=3.3. DAS28-ESR index included SJC and TJC, both scored 0-28, as well as APR determined as ESR in mm/hr, and GH (ranges 1-100 mm; higher scores=higher disease activity). DAS28=(0.56*√TJC)+(0.28*√SJC) +(0.70*ln ESR) +(0.014*GH). DAS28-ESR scale is transformed and ranges from 0 to 10. Negative CFB indicated improvement. DAS28 >2.6 (clinical remission); DAS28 2.6 to 3.2 (low disease activity); DAS28 >3.2 to 5.1 = moderate to high disease activity. SDAI is sum of TJC and SJC (both scored 0-28), PhGA and PGA of disease activity (both scored 0 to 10 cm as assessed by VAS, higher scores=higher disease activity), and CRP in mg/dL where normal is <1 mg/dL. SDAI=TJC + SJC + PhGA + PGA + CRP. SDAI ranged from 0 to 86. A negative CFB indicated improvement. SDAI <=3.3 (clinical remission), >3.4 to 11 (low disease activity) >11 to 26 (moderate disease activity), and >26 = (high/severe disease activity). | ITT population | Posted | Number | percentage of participants | Baseline up to approximately 104 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to RA Crisis Among Participants Who Discontinued After Clinical Remission | RA crisis is any worsening of participant disease acitivity that, in the opinion of the investigator, required intensified treatment other than supportive therapy, and may have included restart of the treatment with the study drug. Time to RA crisis is defined as the period of remission without drug until the RA crisis documentation. | ITT population | Posted | Mean | Standard Deviation | days | Baseline up to approximately 104 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | CFB in PGA of Disease Activity Using VAS Score at Specified Time Points | PGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative CFB indicated improvement. | ITT population. Here, 'n' represents the number of participants available for assessment at a given time point. | Posted | Mean | Standard Deviation | mm | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | CFB in PGA of Pain Using VAS Score at Specified Time Points | PGA of pain is assessed on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm, and is described as "unbearable pain". A negative change indicated improvement. | ITT population. Here, 'n' represents the number of participants available for assessment at a given time point. | Posted | Mean | Standard Deviation | mm | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points | PhGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). | ITT population. Here, 'n' represents the number of participants available for assessment at a given time point. | Posted | Mean | Standard Deviation | mm | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points | HAQ-DI is a self-reported participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Total score for HAQ-DI is the sum of all questions and ranges from 0 = without any difficulty to 60 = unable to do. A negative CFB indicates improvement. | ITT population. Here, 'n' represents the number of participants available for assessment at a given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks) |
|
|
Baseline up to approximately 104 weeks
Only TEAEs were reported.
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 | Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks. | 2 | 21 | 20 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal bleeding | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Bronchopneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cardiac arrhythimia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dizziness | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Diabetes mellitus | Endocrine disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Menstruation irregular | Endocrine disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Scleritis | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Immune system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vaginitis Bacterial | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Viraemia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Sciatica | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyogenic Granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vaginitis Bacterial | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Acute Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Allergic Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Tracheobronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Blepharitis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Mesenteric thrombosis | Vascular disorders | MedDRA (14.1) | 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-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|