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| Name | Class |
|---|---|
| Chugai Pharma Europe Ltd. | INDUSTRY |
ARATA is a prospective, non-interventional, multicenter, observational study in Germany to evaluate the long-term effectiveness and tolerability of subcutaneously administered tocilizumab in participants with rheumatoid arthritis in daily clinical practice. Participants will be followed over an observation period of up to 2 years after the initial injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Rheumatoid Arthritis | Participants with active rheumatoid arthritis who are prescribed tocilizumab treatment according to the marketing authorization by their physician will be followed under routine conditions over an observation period of up to 2 years if baseline and disease characteristics data are available. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment | Up to Week 104 | |
| Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants | Up to Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Mean DAS28-ESR Score | Baseline up to Week 104 | |
| Percentage of Participants with Continuation of Tocilizumab | Up to Week 104 | |
| Mean Retention Time of Tocilizumab |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with active rheumatoid arthritis who are prescribed subcutaneous tocilizumab treatment by their physician prior to and independent of the inclusion of the participant into the study. Participant can be enrolled into the study at maximum 1 month after first tocilizumab administration if baseline and disease characteristics data are available.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIRI - Centrum für Innovative Diagnostik und Therapie Rheumatologie/ Immunologie (GmbH) | Frankfurt | 60528 | Germany |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Up to Week 104 |
| Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment | From Baseline up to tocilizumab treatment discontinuation (Up to Week 104) |
| Percentage of Participants with Concomitant Treatment with Methotrexate (MTX) | Up to Week 104 |
| Percentage of Participants with Low Disease Activity Defined by DAS28-ESR | Up to Week 104 |
| Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI) | Up to Week 104 |
| Percentage of Participants with Low Disease Activity Defined by CDAI | Up to Week 104 |
| Change from Baseline in Mean CDAI Score | Baseline up to Week 104 |
| Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response | At Month 3 and Month 6 |
| Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs) | Up to Week 104 |
| Mean Dose Used for Concomitant GCs | Up to Week 104 |
| Percentage of Participants with Dose Reduction for Concomitant GCs | Up to Week 104 |
| Treatment Satisfaction Visual Analogue Scale (VAS) | Up to Week 104 |
| Treatment User-Friendliness VAS | Up to Week 104 |
| Percentage of Participants with Treatment Adherence | Up to Week 104 |
| Response to Follow-up Treatment in Case of Switch from Tocilizumab | Up to Week 104 |
| Percentage of Participants with Adverse Events During Follow-up Treatment | Up to Week 104 |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Up to Week 104 |
| Hannover Functional Ability Questionnaire (FFbH) Score | Up to Week 104 |
| Percentage of Participants by Type of Physical Exercise | Up to Week 104 |
| Percentage of Participants by Frequency of Physical Exercise | Up to Week 104 |
| Percentage of Participants by Duration of Physical Exercise | Up to Week 104 |
| Fatigue-VAS | Up to Week 104 |
| Sleep Disturbance-VAS | Up to Week 104 |
| State-Trait Anxiety Inventory (STAI) Questionnaire | Up to Week 104 |
| Beck Depression Inventory (BDI) Questionnaire | Up to Week 104 |
| Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) | Up to Week 104 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |