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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006125-14 | EudraCT Number |
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This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RoActemra/Actemra single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8 mg/kg intravenously every 4 weeks for 104 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. Adverse Events of Special Interest for this study were: Serious and/or medically significant infections; myocardial infarction/Acute coronary syndrome; Gastrointestinal perforation; Malignancies; Anaphylaxis/hypersensitivity reactions; Demyelinating disorders; Stroke and Serious and/or medically significant bleeding and hepatic events. | End of Study (Week 104 or early withdrawal) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) | The DAS28 (ESR) score is a measure of the participant's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR) and general health status. The DAS28-ESR scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity, DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. |
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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 |
|---|---|---|---|---|---|---|
| Budapest | 1027 | Hungary | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab | Tocilizumab (RoActemra/Actemra) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis population included all the enrolled participants in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab | Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. Adverse Events of Special Interest for this study were: Serious and/or medically significant infections; myocardial infarction/Acute coronary syndrome; Gastrointestinal perforation; Malignancies; Anaphylaxis/hypersensitivity reactions; Demyelinating disorders; Stroke and Serious and/or medically significant bleeding and hepatic events. | Analysis population included all the enrolled participants in the study. | Posted | Number | percentage of participants | End of Study (Week 104 or early withdrawal) |
|
End of Study (Week 104 or early withdrawal)
An AE was any untoward medical occurrence in a study participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with the treatment.
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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 | Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Screening and End of Study (Week 104 or early withdrawal) |
| Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI) | The SDAI was defined as the numerical sum of 5 outcome parameters: tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity on a 100 millimeter (mm) Visual analogue scale (VAS) (VAS; 0 = no disease activity and 100 = worst disease activity) and level of C-reactive protein (CRP) (milligram per deciliter [mg/dl], normal < 1 mg/dl). SDAI total score = 0-86 where a higher score reflects worsening disease. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. | Screening and End of Study (Week 104 or early withdrawal) |
| Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC) | Tender joint count was performed by a skilled assessor, evaluating 68 joints for tenderness. | Week 12 and Week 104 |
| Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC) | Swollen joint count was performed by a skilled assessor, evaluating 66 joints for swelling. | Week 12 and Week 104 |
| Time to Rheumatoid Arthritis (RA) Flare | RA flare was defined as any worsening of the participant's disease activity that in the opinion of the Investigator required treatment intensification beyond supportive therapy which included restarting of the study drug treatment. Time to RA flare was defined as the period of drug-free remission until documentation of RA flare. Drug-free remission was defined as clinical remission (based on DAS28-ESR < 2.6 and /or SDAI ≤ 3.3) for two consecutive assessment visits, followed by discontinuation of tocilizumab, at the Investigator's discretion, at the second assessment visit. | End of Study (Week 104 or early withdrawal) |
| Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity | The participant global assessment of disease activity was measured using a 100 mm VAS ranging from 0=very good to 100=very bad. | Week 12 and Week 104 |
| Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain | A participant's overall assessment of pain on a VAS was assessed with a question concerning the amount of pain due to arthritis. Pain was assessed on a 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). | Week 12 and Week 104 |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | The Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible scores range from 0 to 3, where 0=least difficulty, and 3=extreme difficulty. | End of Study (Week 104 or early withdrawal) |
| Debrecen |
| 4032 |
| Hungary |
| Eger | 3300 | Hungary |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Tocilizumab | Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study. |
|
|
| Secondary | Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) | The DAS28 (ESR) score is a measure of the participant's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR) and general health status. The DAS28-ESR scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity, DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. | Analysis population included all the enrolled participants in the study. | Posted | Number | participants | Screening and End of Study (Week 104 or early withdrawal) |
|
|
|
| Secondary | Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI) | The SDAI was defined as the numerical sum of 5 outcome parameters: tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity on a 100 millimeter (mm) Visual analogue scale (VAS) (VAS; 0 = no disease activity and 100 = worst disease activity) and level of C-reactive protein (CRP) (milligram per deciliter [mg/dl], normal < 1 mg/dl). SDAI total score = 0-86 where a higher score reflects worsening disease. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. | Analysis population included all the enrolled participants in the study. | Posted | Number | participants | Screening and End of Study (Week 104 or early withdrawal) |
|
|
|
| Secondary | Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC) | Tender joint count was performed by a skilled assessor, evaluating 68 joints for tenderness. | Analysis population included all the evaluable participants for this outcome measure. "n" included all the participants analyzed on that particular time point. | Posted | Number | participants | Week 12 and Week 104 |
|
|
|
| Secondary | Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC) | Swollen joint count was performed by a skilled assessor, evaluating 66 joints for swelling. | Analysis population included all the evaluable participants for this outcome measure. "n" included all the participants analyzed on that particular time point. | Posted | Number | participants | Week 12 and Week 104 |
|
|
|
| Secondary | Time to Rheumatoid Arthritis (RA) Flare | RA flare was defined as any worsening of the participant's disease activity that in the opinion of the Investigator required treatment intensification beyond supportive therapy which included restarting of the study drug treatment. Time to RA flare was defined as the period of drug-free remission until documentation of RA flare. Drug-free remission was defined as clinical remission (based on DAS28-ESR < 2.6 and /or SDAI ≤ 3.3) for two consecutive assessment visits, followed by discontinuation of tocilizumab, at the Investigator's discretion, at the second assessment visit. | This outcome could not be evaluated as there were no participants who had achieved drug-free remission, per protocol definition. | Posted | End of Study (Week 104 or early withdrawal) |
|
|
| Secondary | Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity | The participant global assessment of disease activity was measured using a 100 mm VAS ranging from 0=very good to 100=very bad. | Analysis population included all the evaluable participants for this outcome measure. "n" included all the participants analyzed on that particular time point. | Posted | Number | participants | Week 12 and Week 104 |
|
|
|
| Secondary | Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain | A participant's overall assessment of pain on a VAS was assessed with a question concerning the amount of pain due to arthritis. Pain was assessed on a 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). | Analysis population included all the evaluable participants for this outcome measure. "n" included all the participants analyzed on that particular time point. | Posted | Number | participants | Week 12 and Week 104 |
|
|
|
| Secondary | Health Assessment Questionnaire Disability Index (HAQ-DI) | The Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible scores range from 0 to 3, where 0=least difficulty, and 3=extreme difficulty. | Analysis population included all the enrolled participants in the study. | Posted | Mean | Standard Deviation | units on a scale | End of Study (Week 104 or early withdrawal) |
|
|
|
| 0 |
| 12 |
| 9 |
| 12 |
| Ranula | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | 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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| High Disease Activity (Baseline) |
|
| Remission (End of Study) |
|
| Low Disease Activity (End of Study) |
|
| Moderate Disease Activity (End of Study) |
|
| High Disease Activity (End of Study) |
|
| Title | Measurements |
|---|---|
|
| High Disease Activity (Baseline) |
|
| Remission (End of Study) |
|
| Low Disease Activity (End of Study) |
|
| Moderate Disease Activity (End of Study) |
|
| High Disease Activity (End of Study) |
|
| Title | Measurements |
|---|---|
|
| Decreased (Week 104;n=4) |
|
| Unchanged (Week 104;n=4) |
|
| Increased (Week 104;n=4) |
|
| Title | Measurements |
|---|---|
|
| Decreased (Week 104;n=4) |
|
| Unchanged (Week 104;n=4) |
|
| Increased (Week 104;n=4) |
|
| Title | Measurements |
|---|---|
|
| Decreased (Week 104;n=4) |
|
| Unchanged (Week 104;n=4) |
|
| Increased (Week 104;n=4) |
|
| Title | Measurements |
|---|---|
|
| Decreased (Week 104;n=4) |
|
| Unchanged (Week 104;n=4) |
|
| Increased (Week 104;n=4) |
|