An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice

Study Overview
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Brief Summary
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This prospective, multi-center, observational study will evaluate factors influencing the use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from participants for 12 months following initiation of tocilizumab treatment.

Official Title
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Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Tocilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants, >/= 18 years of age Patients with rheumatoid arthritis for whom the rheumatologist decides to start tocilizumab in combination with DMARD or as monotherapy Exclusion Criteria: Current participation in a clinical trial in rheumatoid arthritis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tocilizumab<br>Tocilizumab administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice. | Biological: Tocilizumab<br>* Tocilizumab administered according to prescribing information and normal clinical practice.<br>* Other names: Actemra®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion | The number of participants assigned to tocilizumab monotherapy versus tocilizumab combination therapy is reported. A multivariate analysis was performed to search for predictive factors for the initiation of tocilizumab in monotherapy. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX) | The percentage of participants who discontinued MTX treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation. Reason for discontinuation Other Intolerance = intolerance other than cytopenia or hepatic cytolysis. | Day 1 (assessment of discontinuations within prior 2 years) | 
| Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide | The percentage of participants who discontinued leflunomide treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation. | Day 1 (assessment of discontinuations within prior 2 years) | 
| Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine | The percentage of participants who discontinued sulfasalazine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation. | Day 1 (assessment of discontinuations within prior 2 years) | 
| Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine | The percentage of participants who discontinued hydroxychloroquine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation. | Day 1 (assessment of discontinuations within prior 2 years) | 
| Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Unspecified Conventional Synthetic Disease-modifying Antirheumatic Drugs (csDMARDs) | The percentage of participants who discontinued treatment with unspecified csDMARDs prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation. | Day 1 (assessment of discontinuations within prior 2 years) | 
| Mean Number of Tocilizumab Infusions Over the Study Period |  | Up to 30 months | 
| Percentage of Participants Who Received Tocilizumab Infusions Over the Study Period | The percentage of participants who received infusions is presented by category of total infusions received over the study period. | Up to 13.4 months | 
| Percentage of Participants With No Modification of Tocilizumab Treatment Over the Study Period | The percentage of participants with no modifications (dose modification or discontinuation) is presented. | Up to 30 months | 
| Percentage of Participants With at Least One csDMARD Intensification During the Study | csDMARD intensification was defined as an addition of a csDMARD without suppression of other csDMARD, dose increase of a csDMARD, switch (addition and suppression) of a csDMARD without intolerance, biological abnormality or symptom improvement to the suppressed csDMARD, or modification of the MTX administration route (from oral route to intramuscular/subcutaneous) with dose increase or maintenance. | Up to 30 months | 
| Percentage of Participants in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity (LDA) at Month 12 | DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of ≤3.2 was considered to be DAS28-ESR LDA. Participants with missing data were considered to have failed to achieve the outcome. | Month 12 | 
| Percentage of Participants With DAS28-ESR Remission at Month 12 | DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of <2.6 was considered to be DAS28-ESR remission. Participants with missing data were considered to have failed to achieve the outcome. | Month 12 | 
| Percentage of Participants With Clinical Disease Activity Index (CDAI) LDA at Month 12 | CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient's global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤10 was considered to be CDAI LDA. Participants with missing data were considered to have failed to achieve the outcome. | Month 12 | 
| Percentage of Participants With CDAI Remission at Month 12 | CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient's global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤2.8 was considered to be CDAI remission. Participants with missing data were considered to have failed to achieve the outcome. | Month 12 | 
| Percentage of Participants With Simplified Disease Activity Index (SDAI) LDA at Month 12 | SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, C-reactive protein (CRP) (milligrams per liter (mg/L)) per , and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤11 was considered to be SDAI LDA. Participants with missing data were considered to have failed to achieve the outcome. | Month 12 | 
| Percentage of Participants With SDAI Remission at Month 12 | SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, CRP (mg/L), and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤3.3 was considered to be SDAI remission. Participants with missing data were considered to have failed to achieve the outcome. | Month 12 | 
| Percentage of Participants With American College or Rheumatology (ACR)20, ACR50, and ACR70 at Month 12 | ACR20/50/70 response was calculated as improvement (from baseline) of at least 20/50/70% (respectively) of tender and of swollen joints, and improvement from baseline of least 20/50/70% (respectively) in at least 3 of the 5 following parameters: participant's pain assessment, patient's global assessment of disease activity, physician's global assessment of disease activity, health assessment questionnaire disability index (HAQ-DI) score, and ESR (mm/hour) or CRP (mg/L). Participants with missing data were considered to have failed to achieve the outcome. | Month 12 | 
| Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Month 12 | EULAR response was categorized as good or moderate response and was calculated as the difference between DAS28-ESR scores at baseline and Month 12. DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. If diminution from baseline >1.2 and score ≤3.2 at Month 12 = good response If diminution from baseline >1.2 and score >3.2 at Month 12 = moderate response If diminution from baseline >0.6 and ≤1.2, and score ≤5.1 at Month 12 = moderate response If diminution from baseline >0.6 and ≤1.2, and score >5.1 at Month 12 = non-response If diminution from baseline ≤1.2 at Month 12 = non-response Participants with missing data were considered as non-response | Month 12 | 
| Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | The HAQ-DI is a participant-reported assessment of ability to perform daily living activities. This composite index score ranges from 0 (normal) to 3 (total functional disability) and includes questions regarding 8 domains (dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week). A decrease in score corresponds to improvement in participant-assessed health state. | Baseline; Month 6; Month 12 | 
| Mean Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score | The RAID questionnaire is a participant-reported outcome measure evaluating the impact of rheumatoid arthritis on participant quality of life. This composite index score ranges from 0 (best) to 10 (worst) and includes questions regarding 7 domains (pain, functional disability assessment, fatigue, sleep, physical well-being, emotional well-being, coping). A decrease in score corresponds to improvement in participant-assessed health state. | Baseline; Month 6, Month 12 | 
| Percentage of Participants With Acceptable Health State Assessed by the Patient Acceptable Symptom State (PASS) Questionnaire. | Participants were asked: If you were to remain in the same condition for the next few months as you have been over the last 8 days, would this be 1) acceptable, 2) unacceptable? The percentage of participants who responded acceptable at each time point is presented. | Baseline; Month 6; Month 12 | 
| Percentage of Participants With Adverse Events | An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding if accompanied by clinical symptoms, results in a change in study treatment, results in a medical intervention or a change in concomitant therapy or clinically significant in the investigator's judgment), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Up to 30 months |