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This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in routine clinical practice in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment in accordance with the local label were followed for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Biological | Tocilizumab was administered according to the local label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants on Tocilizumab at 6 Months After Treatment Initiation | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis | Systemic manifestation measured by C-reactive protein levels > 3 | At baseline |
| Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with rheumatoid arthritis (RA) initiated on treatment with tocilizumab
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ABK Reuma SRL- Medicentro BioCiencias | Lima | Lima 21 | Peru | |||
| Hospital de la Mujer |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab | Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label). Tocilizumab: Tocilizumab was administered according to the local label. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab | Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label). Tocilizumab: Tocilizumab was administered according to the local label. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants on Tocilizumab at 6 Months After Treatment Initiation | Posted | Number | participants | At 6 months |
|
|
From baseline to end of study, approximately 16 months.
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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 with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label). Tocilizumab: Tocilizumab was administered according to the local label. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Keratitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 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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DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" includes participants, who were treated with DMARDs 6 months before being included in the study. "DMARDs treatment at baseline" includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab. |
| At baseline |
| Number of Participants Starting Tocilizumab After Failing Other Biologic Agents | Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody. | At baseline |
| Median Dose at 6 Months | At 6 months |
| Number of Participants With Dose Modifications at 6 Months | At 6 months |
| Median Duration of Treatment | Approximately 16 months |
| Percentage of Participants Discontinued From Tocilizumab for Safety | Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab. | Approximately 16 months |
| Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy | Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician. | Approximately 16 months |
| Number of Participants Discontinued From Tocilizumab for Other Reasons | This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment. | Approximately 16 months |
| Time to Restoration of Initial Dosing Regimen | Approximately 16 months |
| Non-adherence Rate of Physician to the Recommended Dosing Regimen | Approximately 16 months |
| Percentage of Participants on Tocilizumab Monotherapy at Study Entry | At baseline |
| Total Tender Joint Count (TJC) | At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks |
| Total Swollen Joint Count (SJC) | At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks |
| Disease Activity Score Based on 28 Joints (DAS28) | The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad. The Score is developed under the follow formula: DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score. This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission. | At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks |
| Lima |
| Lima 34 |
| Peru |
| Clinica San Borja; Servicio De Reumatologia | Lima | Lima 41 | Peru |
| Clinica El Golf | San Isidro | L27 Lima | Peru |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis | Systemic manifestation measured by C-reactive protein levels > 3 | Posted | Number | percentage of participants | At baseline |
|
|
|
| Secondary | Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure | DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" includes participants, who were treated with DMARDs 6 months before being included in the study. "DMARDs treatment at baseline" includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab. | Posted | Number | percentage of participants | At baseline |
|
|
|
| Secondary | Number of Participants Starting Tocilizumab After Failing Other Biologic Agents | Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody. | Posted | Number | participants | At baseline |
|
|
|
| Secondary | Median Dose at 6 Months | Number of participants remaining in the study at 6 months | Posted | Median | Full Range | mg/kg of body weight | At 6 months |
|
|
|
| Secondary | Number of Participants With Dose Modifications at 6 Months | Posted | Number | participants | At 6 months |
|
|
|
| Secondary | Median Duration of Treatment | Posted | Median | Full Range | months | Approximately 16 months |
|
|
|
| Secondary | Percentage of Participants Discontinued From Tocilizumab for Safety | Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab. | Posted | Number | percentage of participants | Approximately 16 months |
|
|
|
| Secondary | Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy | Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician. | Posted | Number | percentage of participants | Approximately 16 months |
|
|
|
| Secondary | Number of Participants Discontinued From Tocilizumab for Other Reasons | This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment. | Posted | Number | participants | Approximately 16 months |
|
|
|
| Secondary | Time to Restoration of Initial Dosing Regimen | Not Posted | Approximately 16 months | Participants |
| Secondary | Non-adherence Rate of Physician to the Recommended Dosing Regimen | Not Posted | Approximately 16 months | Participants |
| Secondary | Percentage of Participants on Tocilizumab Monotherapy at Study Entry | Posted | Number | percentage of participants | At baseline |
|
|
|
| Secondary | Total Tender Joint Count (TJC) | Posted | Median | Full Range | Number of tender joints/participant | At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks |
|
|
|
| Secondary | Total Swollen Joint Count (SJC) | Posted | Median | Full Range | Number of swollen joints/participant | At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks |
|
|
|
| Secondary | Disease Activity Score Based on 28 Joints (DAS28) | The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad. The Score is developed under the follow formula: DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score. This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission. | Posted | Median | Full Range | DAS28 score | At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks |
|
|
|
| 1 |
| 16 |
| 4 |
| 16 |
| Corneal ulcer | Eye disorders | Systematic Assessment |
|
| Flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | 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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Observation 4 |
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| Observation 5 |
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| Title | Measurements |
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| Observation 3 |
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| Observation 4 |
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| Observation 5 |
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| Title | Measurements |
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| Observation 3 |
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| Observation 4 |
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| Observation 5 |
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