Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
BIOLOGICALTocilizumab
Tocilizumab was administered according to the local label.
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
* Adults, \>/= 18 years of age * Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria * Participants in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label); this can include participants who have received tocilizumab treatment within 8 weeks prior to the enrollment visit
Exclusion criteria
* Participants who have received tocilizumab more than 8 weeks prior to the enrollment visit * Participants who have 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 * History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants on Tocilizumab at 6 Months After Treatment Initiation | At 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure | At baseline | 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. |
| Number of Participants Starting Tocilizumab After Failing Other Biologic Agents | At baseline | Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody. |
| 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 | Approximately 16 months | Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab. |
| Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy | Approximately 16 months | Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician. |
| Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis | At baseline | Systemic manifestation measured by C-reactive protein levels \> 3 |
| 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) | 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 | 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. |
| Number of Participants Discontinued From Tocilizumab for Other Reasons | Approximately 16 months | This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment. |
Countries
Peru
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of insurance coverage | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Tocilizumab |
|---|---|
| Age, Continuous | 55 years |
| Region of Enrollment Peru | 16 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
Primary
Number of Participants on Tocilizumab at 6 Months After Treatment Initiation
Time frame: At 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Number of Participants on Tocilizumab at 6 Months After Treatment Initiation | 14 participants |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort | Disease Activity Score Based on 28 Joints (DAS28) | Visit 1 | 6.29 DAS28 score |
| Cohort | Disease Activity Score Based on 28 Joints (DAS28) | Observation 1 | 2.87 DAS28 score |
| Cohort | Disease Activity Score Based on 28 Joints (DAS28) | Observation 2 | 2.23 DAS28 score |
| Cohort | Disease Activity Score Based on 28 Joints (DAS28) | Observation 3 | 2.16 DAS28 score |
| Cohort | Disease Activity Score Based on 28 Joints (DAS28) | Observation 4 | 2.45 DAS28 score |
| Cohort | Disease Activity Score Based on 28 Joints (DAS28) | Observation 5 | 2.41 DAS28 score |
Secondary
Median Dose at 6 Months
Time frame: At 6 months
Population: Number of participants remaining in the study at 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort | Median Dose at 6 Months | 8 mg/kg of body weight |
Secondary
Median Duration of Treatment
Time frame: Approximately 16 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort | Median Duration of Treatment | 6 months |
Secondary
Non-adherence Rate of Physician to the Recommended Dosing Regimen
Time frame: 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.
Time frame: Approximately 16 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Number of Participants Discontinued From Tocilizumab for Other Reasons | 3 participants |
Secondary
Number of Participants Starting Tocilizumab After Failing Other Biologic Agents
Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.
Time frame: At baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Number of Participants Starting Tocilizumab After Failing Other Biologic Agents | 1 participants |
Secondary
Number of Participants With Dose Modifications at 6 Months
Time frame: At 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Number of Participants With Dose Modifications at 6 Months | 4 participants |
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.
Time frame: Approximately 16 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy | 0 percentage of participants |
Secondary
Percentage of Participants Discontinued From Tocilizumab for Safety
Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab.
Time frame: Approximately 16 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Percentage of Participants Discontinued From Tocilizumab for Safety | 0 percentage of participants |
Secondary
Percentage of Participants on Tocilizumab Monotherapy at Study Entry
Time frame: At baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Percentage of Participants on Tocilizumab Monotherapy at Study Entry | 12.5 percentage of participants |
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.
Time frame: At baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort | Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure | Prior DMARDs treatment | 18.8 percentage of participants |
| Cohort | Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure | DMARDs treatment at baseline | 62.5 percentage of participants |
Secondary
Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis
Systemic manifestation measured by C-reactive protein levels \> 3
Time frame: At baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis | 93.8 percentage of participants |
Secondary
Time to Restoration of Initial Dosing Regimen
Time frame: Approximately 16 months
Secondary
Total Swollen Joint Count (SJC)
Time frame: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort | Total Swollen Joint Count (SJC) | Visit 1 | 18 Number of swollen joints/participant |
| Cohort | Total Swollen Joint Count (SJC) | Observation 1 | 0.5 Number of swollen joints/participant |
| Cohort | Total Swollen Joint Count (SJC) | Observation 2 | 0 Number of swollen joints/participant |
| Cohort | Total Swollen Joint Count (SJC) | Observation 3 | 0 Number of swollen joints/participant |
| Cohort | Total Swollen Joint Count (SJC) | Observation 4 | 0 Number of swollen joints/participant |
| Cohort | Total Swollen Joint Count (SJC) | Observation 5 | 0 Number of swollen joints/participant |
Secondary
Total Tender Joint Count (TJC)
Time frame: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort | Total Tender Joint Count (TJC) | Visit 1 | 18 Number of tender joints/participant |
| Cohort | Total Tender Joint Count (TJC) | Observation 1 | 0 Number of tender joints/participant |
| Cohort | Total Tender Joint Count (TJC) | Observation 2 | 0 Number of tender joints/participant |
| Cohort | Total Tender Joint Count (TJC) | Observation 3 | 0 Number of tender joints/participant |
| Cohort | Total Tender Joint Count (TJC) | Observation 4 | 0 Number of tender joints/participant |
| Cohort | Total Tender Joint Count (TJC) | Observation 5 | 0 Number of tender joints/participant |