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The purpose of this clinical trial is to prospectively evaluate RA activity using the assessment of change in DAS28 under local conditions in Slovakia in participants who are treated with subcutaneously administered tocilizumab pursuant to the recommendations of the Ministry of Health of the Slovak Republic in order to better assess the disease activity and impairment of the joint function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Participants will receive tocilizumab (162 milligrams [mg]) SC injection for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Tocilizumab will be administered at 162 mg SC injection for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average change from baseline in DAS28 | up to Week 24 | |
| Average change from baseline in DAS28 | up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants achieving clinical remission defined as a DAS28 <2.6 | Baseline, Week 12, 24, 36, and 48 | |
| Percentage of participants achieving a DAS28 >=3.2 | Baseline, Week 12, 24, 36, and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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Moderate to severe RA participants who are treated with tocilizumab
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banská Bystrica | 975 17 | Slovakia | ||||
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| Evaluation of participant's pain using visual analogue scale (VAS) | Baseline, Week 12, 24, 36, and 48 |
| Evaluation of the disease activity by participant using VAS | Baseline, Week 12, 24, 36, and 48 |
| Evaluation of the disease activity by Doctor using VAS | Baseline, Week 12, 24, 36, and 48 |
| DAS28-joint count (erythrocyte sedimentation rate) [DAS28(ESR)] score | Baseline, Week 12, 24, 36, and 48 |
| DAS28-joint count (C-reactive protein) [DAS28(CRP)] score | Baseline, Week 12, 24, 36, and 48 |
| Absolute and percent change in the Health Assessment Questionnaire (HAQ) | Baseline, Week 12, 24, 36, and 48 |
| Bratislava |
| 813 69 |
| Slovakia |
| Bratislava | 826 06 | Slovakia |
| Nitra | 950 01 | Slovakia |
| Piešťany | 921 01 | Slovakia |
| 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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