Rheumatoid Arthritis
Conditions
Brief summary
This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).
Interventions
DRUGMethotrexate
Administered as per investigator's discretion. Investigator could also suggest any other csDMARDs instead of methotrexate.
DRUGTocilizumab
Tocilizumab treatment will be administered SC at the discretion of the investigator in accordance with local clinical practice and local labelling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants at least 18 years old * Participants with moderate to severe RA not previously treated with TCZ (Intravenous \[IV\] or SC) for whom the rheumatologists have decided to initiate TCZ SC treatment as monotherapy or in combination with another conventional synthetic disease modifying anti-rheumatic drugs (csDMARD)
Exclusion criteria
* Participants taking part in a clinical trial on RA at the time of inclusion * Participants with a contra-indication to TCZ SC therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Were on TCZ SC for a Period of 12 Months | Up to 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Simple Disease Activity Index (SDAI) | Months 3, 6, 12, and 18 |
| Clinical Disease Activity Index (CDAI) | Months 3, 6, 12, and 18 |
| Percentage of Participants With EUropean League Against Rheumatism (EULAR) Response | Months 3, 6, 12, and 18 |
| Percentage of Participants Who Were on TCZ SC for a Period of 6 Months | Up to 6 Months |
| Percentage of Participants Who Were on TCZ SC for a Period of 18 Months | Up to 18 Months |
| Percentage of Participants who were on TCZ SC at 6, 12 and 18 Months Among 2 Subgroups: Participants Administered TCZ SC as Monotherapy and Participants Administered TCZ SC with Methotrexate or csDMARD | Up to 18 Months |
| Dose of Concomitant Steroids After Introduction of TCZ SC | Months 6, 12, and 18 |
| Disease Activity Score Based on 28 Joints Count and C-Reactive Protein (DAS28-CRP) | Months 3, 6, 12, and 18 |
| Percentage of Participants with Definitive Discontinuation of Treatment | Up to 18 Months |
| Percentage of Participants Performing All Visits at Hospital/Office Based Rheumatologist | Up to 18 Months |
| Percentage of Participants Taking Sick Leaves or Getting Hospitalized Due to RA | Up to 18 Months |
| Tender Joints Count | Months 3, 6, 12, and 18 |
| Swollen Joints Count | Months 3, 6, 12, and 18 |
| Disease Activity Score Based of 28 Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Months 3, 6, 12, and 18 |
| Number of Participants with Adherence to TCZ SC Using the Compliance Questionnaire of Rheumatology 5 (CQR5) and Participants Diary Data | Months 6, 12, and 18 |
Countries
France
Outcome results
None listed