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| Name | Class |
|---|---|
| nv Roche sa | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid Arthritis participants treated with Tocilizumab SC | Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl) | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Participant with a diagnosis of moderate to severe RA defined as DAS28 more than or equal to (>=) 3.7, naïve to TCZ and in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASZ Aalst | Aalst | 9300 | Belgium | |||
| AZ Sint Lucas Brugge |
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|
| 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 |
| Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3) | 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 having SJC <=1 | Up to Week 24 |
| Patient Global Assessment of disease activity visual analogue scale (VAS) score | Up to Week 24 |
| Physician Global Assessment of disease activity VAS score | Up to Week 24 |
| 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 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 |
| Assebroek |
| 8310 |
| Belgium |
| AZ Sint Jan | Bruges | 8000 | Belgium |
| CHU St Pierre (César de Paepe) | Brussels | 1000 | Belgium |
| HIS (Etterbeek Ixelles) | Brussels | 1050 | Belgium |
| Hospital Erasme; Neurologie | Brussels | 1070 | Belgium |
| AZ Sint Blasius (Dendermonde) | Dendermonde | 9200 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| Reumacentrum Genk | Genk | 3600 | Belgium |
| Reumaclinic | Genk | 3600 | Belgium |
| GHdC Site Saint-Joseph | Gilly (Charleroi) | 6000 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| Private Practice | Lokeren | 9160 | Belgium |
| CHU UCL Mont-Godinne | Mont-godinne | 5530 | Belgium |
| AZ Damiaan | Ostend | 8400 | Belgium |
| AZ Oudenaarde | Oudenaarde | 9700 | Belgium |
| AZ Alma vzw (Sijsele) | Sijsele | 8340 | Belgium |
| AZ Sint Jozef Malle | Westmalle | 2390 | Belgium |
| Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| CVBA Diagnosecentrum Voorkempen | Zoersel | 2980 | Belgium |
| Höpital Kirchberg; Rheumatology | Luxembourg | 2540 | Luxembourg |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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