Rheumatoid Arthritis
Conditions
Brief summary
This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of treatment.
Interventions
OTHERNo intervention
No intervention administered in this study
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Moderate to severe rheumatoid arthritis according to revised (1987) American college of rheumatology (ACR) criteria * Initiated on tocilizumab treatment by the treating physician in accordance with the Canadian product monograph * Informed consent to data being subject to computerized data processing * Participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage
Exclusion criteria
* Received tocilizumab prior to enrolment visit * Previously received tocilizumab in a clinical trial or for compassionate use * Enrolled in an ongoing clinical trial and/or received treatment with any investigational agent within 4 weeks, or 5 half-lives of the investigational agent, whichever is longer, before starting treatment with tocilizumab * Participation in another clinical trial or industry sponsored observational study * History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation | At 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Swollen Joint Count (SJC) | From baseline to Month 12 | Following an assessment of 66 joints for swelling, joints were classified as swollen or not swollen by the investigator. |
| Change From Baseline in Disease Activity Score 28 (DAS28) | From baseline to Month 12 | The DAS28 scale is a combined index for measuring disease activity in rheumatoid arthritis. Scores range from 0 to 10, with higher scores representing more disease activity. |
| Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS) | From baseline to Month 12 | With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of morning stiffness. |
| Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS) | From baseline to Month 12 | With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity. |
| Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS) | From baseline to Month 12 | With VAS, physicians specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity. |
| Change From Baseline in Tender Joint Count (TJC) | From baseline to Month 12 | Following an assessment of 68 joints for tenderness, joints were classified as tender or not tender by the investigator. |
| Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS) | From baseline to Month 12 | With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of fatigue. |
| Change From Baseline in C-Reactive Protein (CRP) | From baseline to Month 12 | The serum concentration of C-reactive protein (CRP) was measured. A reduction in the level of CRP was considered an improvement. |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | From baseline to Month 12 | The erythrocyte sedimentation rate (ESR) was analyzed at the site using the kit provided by the central laboratory. A reduction in the level of ESR was considered an improvement. |
| Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | At 12 months | The extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants with available data. |
| Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | At 12 months | The severity of extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants who responded YES to changes in extra- articular RA manifestations (new presence or change in severity) since the last visit. NA=Not applicable |
| Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS) | From baseline to Month 12 | With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of pain. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthritis Cohort The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
No intervention: No intervention administered in this study | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Death | 2 |
| Overall Study | Lack of Efficacy | 13 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other Reason | 4 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Rheumatoid Arthritis Cohort |
|---|---|
| Age, Continuous | 55.43 years STANDARD_DEVIATION 13.52 |
| Sex: Female, Male Female | 160 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 68 / 198 |
| serious Total, serious adverse events | 31 / 198 |
Outcome results
Primary
Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
Time frame: At 6 months
Population: All participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rheumatoid Arthritis Cohort | Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation | 81.5 percentage of participants |
Secondary
Change From Baseline in C-Reactive Protein (CRP)
The serum concentration of C-reactive protein (CRP) was measured. A reduction in the level of CRP was considered an improvement.
Time frame: From baseline to Month 12
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the CRP assessment were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Change From Baseline in C-Reactive Protein (CRP) | -16.35 mg/L | Standard Deviation 31.68 |
Secondary
Change From Baseline in Disease Activity Score 28 (DAS28)
The DAS28 scale is a combined index for measuring disease activity in rheumatoid arthritis. Scores range from 0 to 10, with higher scores representing more disease activity.
Time frame: From baseline to Month 12
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the DAS28 assessment were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Change From Baseline in Disease Activity Score 28 (DAS28) | -3.00 units on a scale | Standard Deviation 1.73 |
Secondary
Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)
With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of morning stiffness.
Time frame: From baseline to Month 12
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Duration of Morning Stiffness on the VAS were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS) | -24.31 units on a scale | Standard Deviation 30.04 |
Secondary
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
The erythrocyte sedimentation rate (ESR) was analyzed at the site using the kit provided by the central laboratory. A reduction in the level of ESR was considered an improvement.
Time frame: From baseline to Month 12
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the ESR assessment were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | -16.79 mm/hr | Standard Deviation 22.71 |
Secondary
Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)
With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of fatigue.
Time frame: From baseline to Month 12
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Patient Assessment of Fatigue on the VAS were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS) | -23.94 units on a scale | Standard Deviation 30.55 |
Secondary
Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)
With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of pain.
Time frame: From baseline to Month 12
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Pain on the VAS were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS) | -27.99 units on a scale | Standard Deviation 30.47 |
Secondary
Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)
With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.
Time frame: From baseline to Month 12
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Disease Activity on the VAS were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS) | -24.90 units on a scale | Standard Deviation 29.3 |
Secondary
Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)
With VAS, physicians specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.
Time frame: From baseline to Month 12
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Disease Activity on the VAS were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS) | -39.95 units on a scale | Standard Deviation 28.28 |
Secondary
Change From Baseline in Swollen Joint Count (SJC)
Following an assessment of 66 joints for swelling, joints were classified as swollen or not swollen by the investigator.
Time frame: From baseline to Month 12
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Swollen Joint Count were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Change From Baseline in Swollen Joint Count (SJC) | -8.66 swollen joints | Standard Deviation 7.67 |
Secondary
Change From Baseline in Tender Joint Count (TJC)
Following an assessment of 68 joints for tenderness, joints were classified as tender or not tender by the investigator.
Time frame: From baseline to Month 12
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Tender Joint Count were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Change From Baseline in Tender Joint Count (TJC) | -12.71 tender joints | Standard Deviation 12.84 |
Secondary
Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months
The severity of extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants who responded YES to changes in extra- articular RA manifestations (new presence or change in severity) since the last visit. NA=Not applicable
Time frame: At 12 months
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Extra-Articular Manifestations were included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Nodules: Mild | 5 participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Nodules: Moderate | 0 participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Nodules: Severe | 0 participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Raynauds Phenomenon: Mild | NA participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Secondary Sjogrens Syndrome: Mild | 3 participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Secondary Sjogrens Syndrome: Moderate | 1 participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Secondary Sjogrens Syndrome: Severe | 0 participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Pulmonary Fibrosis: Moderate | NA participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Pulmonary Fibrosis: Severe | NA participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Pericarditis: Mild | NA participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Severe Cutaneous Vasculitis: Mild | NA participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Severe Cutaneous Vasculitis: Moderate | NA participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Weight Loss: Mild | 1 participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Weight Loss: Moderate | 0 participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Weight Loss: Severe | 0 participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Anemia: Mild | 2 participants |
| Rheumatoid Arthritis Cohort | Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | Anemia: Moderate | 0 participants |
Secondary
Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months
The extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants with available data.
Time frame: At 12 months
Population: Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Extra-Articular Manifestations were included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Cohort | Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | Nodules | 3.1 percentage of participants |
| Rheumatoid Arthritis Cohort | Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | Raynauds Phenomenon | 0 percentage of participants |
| Rheumatoid Arthritis Cohort | Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | Secondary Sjogrens Syndrome | 2.5 percentage of participants |
| Rheumatoid Arthritis Cohort | Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | Pulmonary Fibrosis | 0 percentage of participants |
| Rheumatoid Arthritis Cohort | Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | Pericarditis | 0 percentage of participants |
| Rheumatoid Arthritis Cohort | Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | Polyneuropathy | 0 percentage of participants |
| Rheumatoid Arthritis Cohort | Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | Scleritis | 0 percentage of participants |
| Rheumatoid Arthritis Cohort | Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | Severe Cutaneous Vasculitis | 0 percentage of participants |
| Rheumatoid Arthritis Cohort | Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | Weight Loss | 0.6 percentage of participants |
| Rheumatoid Arthritis Cohort | Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | Anemia | 1.2 percentage of participants |