Rheumatoid Arthritis
Conditions
Brief summary
This observational trial will evaluate the effectiveness, the consistency of evaluation scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in participants with RA in daily clinical practice.
Interventions
DRUGTocilizumab
Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.
Sponsors
nv Roche sa
Hoffmann-La Roche
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants naive to TCZ or who have received TCZ SC treatment within 8 weeks prior to the enrolment visit can be included * Participants in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria
Exclusion criteria
* Participants who have received TCZ \>8 weeks prior to the enrolment visit * Participants who have previously received TCZ SC * Participants who have received treatment with any investigational agent within 4 weeks before starting treatment with TCZ SC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl) | Up to Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants having CRP <=1mg/dl | Up to Week 24 |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Up to Week 24 |
| EQ-5D-5L Health Questionnaire (EuroQoL) | Up to Week 24 |
| Morisky Medication-Taking Adherence Scale (MMAS) | Up to Week 24 |
| Percentage of participants using TCZ in monotherapy | At baseline |
| Percentage of participants having SJC <=1 | Up to Week 24 |
| Patient Global Assessment of disease activity visual analogue scale (VAS) score | Up to Week 24 |
| Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR | Up to Week 24 |
| Percentage of participants to achieve low disease activity (LDA) using DAS28 (less than or equal to [<=] 3.2), CDAl (<=10.0) and SDAI (<=11 .0) | Up to Week 24 |
| Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0) | Up to week 24 |
| Physician Global Assessment of disease activity VAS score | Up to Week 24 |
| Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3) | Up to Week 24 |
| Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units) | Up to Week 24 |
| Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units) | Up to Week 24 |
| Percentage of participants to achieve a major and minor improvement in CDAl (more than or equal to [>=]13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively) | Up to Week 24 |
| Time to achieve a major and minor improvement in CDAl (>=13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively) | Up to Week 24 |
| Change from baseline in total tender joint count (TJC) | Up to Week 24 |
| Change from baseline in total swollen joint count (SJC) | Up to Week 24 |
| Percentage of participants having TJC <=1 | Up to Week 24 |
| Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's) | At baseline |
| Percentage of participants presenting a high inflammation (DAS28-ESR >5.1) | At baseline |
| Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3) | Up to Week 24 |
Countries
Belgium, Luxembourg
Outcome results
None listed